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Stevens–Johnson Syndrome (SJS) Lawsuit and Toxic Epidermal Necrolysis (TEN) Lawsuit Information by Stevens–Johnson Syndrome (SJS) Lawyer and Toxic Epidermal Necrolysis (TEN) Lawyer Jason S. Coomer

2012-01-23T08:47:00.000-08:00

Stevens-Johnson Syndrome Lawsuit, Toxic Epidermal Necrolysis Lawsuit, SJS-TEN Lawsuit, Fatal Drug Reaction Lawsuit, and Deadly Medication Reaction Lawsuit Information
by Texas Stevens-Johnson Syndrome Lawyer, Toxic Epidermal Necrolysis Lawyer, and Fatal Drug Reaction Lawyer, Jason S. Coomer

Stevens–Johnson Syndrome and Toxic Epidermal Necrolysis are forms of a very rare, acute, serious, and potentially fatal skin reaction. The skin condition is usually, possibly always, caused by medications. If you believe that you or someone that you love has Stevens–Johnson Syndrome and/or Toxic Epidermal Necrolysis, it is crucial to immediately seek medical attention.

Stevens-Johnson Syndrome Lawyer, Toxic Epidermal Necrolysis Lawyer, SJS-TEN Lawyer, Fatal Skin Drug Reaction Lawyer, and Deadly Skin Medication Reaction Lawyer

Stevens–Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are two forms of a life-threatening condition affecting the skin in which cell death causes the epidermis to separate from the dermis. With this condition a person's skin and mucous membranes react severely to a medication or infection. Often, Stevens-Johnson syndrome begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters, eventually causes the top layer of a person's skin to die and shed. The syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membranes. Persons with Stevens-Johnson syndrome (SJS) should seek immediate medical treatment.

Medications are thought to be the most common cause of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. More than 200 medications have been reported in association with SJS/TEN. It is more often seen with drugs with long half-lives compared to even a chemically similar related drug with a short half-life. A half-life of a medication is the time that half of the delivered dose remains circulating in the body. The most commonly implicated medications are antibacterial sulfonamides. Other drugs that have been associated with Stevens-Johnson Syndrome include: Anti-gout Medications; Non Sterodal Anti-Inflammatory Drugs (NSAIDs); Sulfonamides; Penicillins; Ibuprofen (Advil, Children's Advil, Motrin, Children's Motrin, Advil Allergy Sinus Tablets; Advil Cold & Sinus Tablets; Advil Liqui-Gels; Advil Migraine Capsules; Children's Motrin Chewable Tablets; Motrin Junior Strength Chewable Tablets; Motrin Cold & Sinus Tablets; Motrin IB Tablets; Motrin Infants' Drops, and Nuprin); Ketek; Antibiotic; COX-2 inhibitors Bextra (Valdecoxib); Vioxx (Rofecoxib); Celebrex (Celecoxib); Barbiturates; Sedatives; Feldene (Piroxicam); Naproxen (Aleve); Antibiotic Medications; Zithromax (also known as a z-pack); Keflex (cephalexin); Coreg (carvedilol) (a popular beta blocker); Tolectin; Antifungals; Antivirals; and Anticonvulsants.

Medical Malpractice Stevens-Johnson Syndrome Lawyer, Failure to Diagnose Toxic Epidermal Necrolysis Lawyer, Medical Mistake SJS Lawyer, TEN Lawyer, Medical Malpractice Fatal Skin Drug Reaction Lawyer, and Medical Malpractice Deadly Skin Medication Reaction Lawyer

When diagnosing and treating a person with Stevens–Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), it is important to identify the condition early and discontinue the medications that may be causing the skin reaction. In identifying and diagnosing Stevens–Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), it is also important to determine what medications the patient has been taking and if prior to the rash appearing, the patient suffered from a flu-like illness resembling an upper respiratory tract infection with fever, cough, sore throat, difficulty swallowing, runny nose, sore red eyes, conjunctivitis, as well as general aches and pains.

After the flu-like symptoms, there is typically an abrupt onset of a tender/painful red skin rash starting on the trunk and extending rapidly over hours to days onto the face and limbs. These skin lesions typically include changes in surface color, target lesions, and blisters. The changes in surface color are typically flat, red and diffuse (measles-like) or purple (purpuric) spots. The target lesions or erythema multiforme consists of a polymorphous eruption of macules, papules, and characteristic “target” lesions that are symmetrically distributed with a propensity for the distal extremities. The blisters are typically flaccid, that begin to merge to form sheets of skin detachment, exposing red, oozing dermis. These blisters are positive for the Nikolsky sign which means if the blisters are rubbed gently skin will exfoliation the outermost layer. Nikolsky's sign is almost always present in TEN.

Developing Stevens–Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN) constitutes a dermatological emergency and failure to timely act can result in a more severe reaction or even death. When a person has Stevens–Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN), immediate treatment should be sought and all medications should be discontinued, particularly those known to cause SJS-TEN reactions.

A skin biopsy or autopsy is usually required to confirm the clinical diagnosis and to exclude Staphylococcal Scalded Skin Syndrome (SSSS) and other generalised rashes with blisters.

Stevens-Johnson Syndrome Lawyer, Toxic Epidermal Necrolysis Lawyer, SJS Lawyer, TEN Lawyer, Fatal Skin Drug Reaction Lawyer, and Deadly Skin Medication Reaction Lawyer

Stevens–Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are variants of the same skin condition. The condition presents as severe mucosal erosions with widespread skin lesions. In Stevens–Johnson Syndrome (SJS), epidermal detachment involves less than 10 percent of the total body skin area; transitional Stevens–Johnson Syndrome (SJS)-Toxic Epidermal Necrolysis (TEN) is defined by an epidermal detachment between 10 percent and 30 percent; Toxic Epidermal Necrolysis (TEN) is defined by a detachment greater than 30 percent.

Skin reactions during SJS-TEN can be horrific and death from or suffering from the condition either Stevens–Johnson Syndrome or Toxic Epidermal Necrolysis can be a horrific experience for everyone involved. To help the patient recover it is essential Even worse

Severe skin adverse drug reactions can result in death. Toxic epidermal necrolysis (TEN) has the highest mortality (30-35%); Stevens-Johnson syndrome and transitional forms correspond to the same syndrome, but with less extensive skin detachment and a lower mortality (5-15%). Hypersensitivity syndrome, sometimes called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), has a mortality rate evaluated at about 10%.

To learn more about Stevens–Johnson Syndrome (SJS) Lawsuit and Toxic Epidermal Necrolysis (TEN) Lawsuit Information, please feel free to go to the following webpage: Stevens–Johnson Syndrome (SJS) Lawsuit and Toxic Epidermal Necrolysis (TEN) Lawsuit Information.

Neurostimulation Product Liability Lawsuits and Implantable Neurostimulation Systems Lawsuits

2010-10-03T16:30:00.000-07:00

Neurostimulation Product Liability Lawsuits, Implantable Neurostimulation Systems Lawsuits, and Failed Back Surgery Resulting in Permanent Disability and Paralysis Lawsuits
by Texas Failed Back Surgery Product Liability Lawyer, Jason Coomer

Failed back surgery including defective implantable neurostimulation systems can cause catastrophic injuries and impairment. These failed back surgery cases can be caused by defective spinal-devices and can take significant resources to investigate and file a lawsuit. When investigating these potential failed back surgery lawsuits it is important to know what implant has been used as well as to obtain medical records of the surgery.

Implantable Neurostimulation System Lawsuits, Failed Back Implant Devices, and Failed Spinal Cord, Neck, & Back Surgery Lawsuits

Implantable Neurostimulation Systems have been used for a variety of types of chronic back pain situations including heriniated disks, postlaminectomy paid, Complex Reginal Pay Syndrome, unsuccessful disk surgery, Degenerative Disk Disease, and Failed Back Syndrome. In fact, implantable neurostimulation systems and other spinal-devices are a huge business for the medical implant device industry including Medtronic, a leader in medical implantable devices. Medtronic’s spinal-devices unit has about $3 billion in annual revenue from selling spinal devices including the Medtronic implantable neurostimulation system. With this success, several other companies are developing similar implantable neurostimulation systems.

The Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs—including unilateral or bilateral pain associated with several different conditions. Unfortunately, there are several claims that the implantable neurostimulation system has some defects that can cause serious health problems.

Patients with Serious Back Injuries Including Severed Spinal Cords, Crushed Discs, Bulged Discs, and Herniated Discs when Seeking Pain Relief can sometimes Fall Victim to Defective Products, Negligent Health Care, and "For Profit" Medical Professionals Seeking to Increase Profits

The human spinal cord is basically a bundle of nerves which is surrounded by 33 bones or vertebrae. Located between each vertebrae is a spinal disc which is a liquid filled disc shaped pouch. These discs are stacked on top of one another and act as shock absorbers allowing the spine to flex, bend, and twist. When functioning properly, the vertebrae and discs protect the spinal cord allow nerve impulses to travel from and to the brain to other parts of the body. This allows us to experience sensations, move our bodies, and control many bodily functions.

Problems arise when the vertebrae, discs, or spinal cord are injured. Broken vertebrae can damage and impinge on discs or the spinal cord causing extreme pain, numbness, and loss of control of bodily functions. Back injuries can occur through traumatic events that result in paralysis. Depending where and how severe the injury is will determine what type and how severe the paralysis is.

The human body has remarkable healing potential. Combining determination, proper medical attention, knowledge about an injury, and focus on the healing process can greatly help most injuries. Hiring a lawyer to battle the insurance companies and responsible parties can allow the injured person to focus on the healing process.

If you or a loved one have suffered a traumatic spinal cord injury or other serious back injury including a severed spinal cord, broken vertebrae, crushed discs, herniated discs, or a bulged discs; the most important thing you can do is to find a good medical doctor to assess the injury so you know what you are dealing with and how to best treat the injury. From physical therapy and steroid injections to back surgeries (lumbar diskectomy, cervical fusion, and other lumbar or cervical procedures), there are many different ways to treat a back injury and it is important to know what will work best for you.

Unfortunately, there are also medical clinics, medical implant sales people, and doctors that are more interested in profit and their bottom line than what is best for a patient. Some of these medical professionals carelessly cause painful and difficult conditions to become much worse by paralyzing patients that are seeking relief from pain.

Defective Implantable Neurostimulation System Lawyers, Medical Negligence Failed Back Surgery Lawyers, and Combination Failed Implantable Neurostimulation System Medical Negligence Spine Surgery Lawyers (Defective Implantable Neurostimulation System Medical Device and Medical Negligence Lawsuits)

Texas Failed Back Surgery Defective Implantable Neurostimulation System and Medical Negligence lawyer, Jason S. Coomer, helps individuals and families that have been injured or killed from defective products and surgeon negligence. He commonly works with other Failed Back Surgery and Defective Implantable Neurostimulation System Attorneys throughout the United States and Texas on defective product lawsuits and medical negligence lawsuits.

For more information on Texas Failed Back Surgery Defective Implantable Neurostimulation System and Medical Negligence lawyer, Jason S. Coomer, please go to the following web site, Failed Back Surgery & Implant Neurostimulator Lawsuit Lawyer.

Isotretinoin and Accutane Inflammatory Bowel Disease (Ulcerative Colitis and Crohn's Disease) Lawsuits

2010-07-15T16:13:00.000-07:00

Accutane Crohn's Disease Lawsuits, Accutane Ulcerative Colitis Lawsuits, and Accutane Inflammatory Bowel Disease (IBD) Lawsuits by Texas Accutane Lawyer Jason S. Coomer

Isotretinoin which is sold under several tradename including Accutane is an acne medication that is a synthetic form of Vitamin A. The drug has been commonly sold and marketed to alleviate severe acne symptoms by inhibiting oil gland and cell growth. Scientific evidence has linked the acne drug, Isoterinoin and Accutane, to severe side effects including increased risk of severe digestive problems, inflammatory bowel disease (IBD), Ulcerative Colitis, and Crohn's Disease.

Accutane and Isotretinoin Digestive Disorder Lawsuits including Inflammatory Bowel Disease (IBD), Crohn's Disease, and Ulcerative Colitis
The digestive system provides our bodies with nourishment as well as gets rid of toxins that can cause health problems. The digestive system includes the stomach, large and small intestines, and rectum. It converts the foods we eat into nutrients and absorbs these nutrients into the bloodstream to fuel our bodies. We seldom appreciate the workings of our digestive system unless something goes wrong, as in the case of inflammatory bowel disease (IBD).

Inflammatory bowel disease (IBD) is a group of inflammatory conditions of the colon and small intestine that can cause significant health problems and can be extremely unpleasant and can cause disability. The major types of Inflammatory Bowel Disease IBD are Crohn's Disease and Ulcerative Colitis

Crohn's Disease is a form of inflammatory bowel disease (IBD). It usually affects the intestines, but may occur anywhere from the mouth to the end of the rectum (anus). Crohn's Disease symptoms depend on what part of the gastrointestinal tract is affected. Symptoms range from mild to severe, and can come and go with periods of flare-ups. The main symptoms of Crohn's disease are cramps and abdominal pain, fever, fatigue, loss of appetite, pain with passing stool (tenesmus), persistent & watery diarrhea, and unintentional weight loss. Other symptoms may include constipation, eye inflammation, fistulas (usually around the rectal area, may cause draining of pus, mucus, or stools), joint pain, liver inflammation, mouth ulcers, rectal bleeding and bloody stools, skin rash, and swollen gums.

Ulcerative colitis is a type of inflammatory bowel disease (IBD) that affects the large intestine (colon) and rectum. Symptoms of Ulcerative Colitis can include abdominal pain and cramping that usually disappears after a bowel movement; abdominal sounds (a gurgling or splashing sound heard over the intestine); diarrhea, from only a few episodes to very often throughout the day (blood and mucus may be present); fever; tenesmus (rectal pain); weight loss; gastrointestinal bleeding; joint pain; and nausea and vomiting.

Isotretinoin Acne Medication and Related Health Problems including Inflammatory Bowl Disease IBD, Crohn's Disease, and Ulcerative Colitis

The leading pharmaceutical manufacturers of the acne drug, Isotretinoin, have received billions in revenue from the sale of the acne drug, Isotretinoin and Accutane. Isotretinoin is sold under several trade names including Accutane, Amnesteem, Claravis, Decutan, Isotane, Izotek, Oratane, Isotrex, Isotrexin, Sotret, Ratane, and Raccutane.

Isotretinoin is a medication used for the treatment of severe acne. It was first developed to be used as a chemotherapy medication for the treatment of some forms of cancer. It was later discovered that it was effective and treating severe acne. Though Isotretinoin including Accutane was originally only meant for the treatment of severe acne, over time many dermatologists pushed by pharmaceutical marketing representatives began to prescribe the drug for mild cases.

Isotretinoin including Accutane works by inhibiting the growth and reproduction of oil glands and cells. It depletes the body of molecules that hold water which help to keep skin, eyes, scalp, and joints well lubricated. Scientific research has determined that Isotretinoin including Accutane can cause several health problems including Crohn's Disease, irritable bowel disease, Ulcerative Colitis, depression, suicidal tendencies, birth defects, miscarriages, vision problems, ringing in the ear, psychosis, liver damage, heart attack, stroke, seizures, lowered white blood cell count, and inflammatory bowel disease.

Accutane FDA Action, Accutane Black Box Warning, and Accutane Lawsuits

The FDA has required a black box warning be put on all containers of Accutane, warning of all the known health risks associated with taking Isotretinoin including Accutane. A proper warning label notifying health care providers and users of a drug will typically protect a drug manufacturer from liability. As such, it is thought that because Isotretinoin and Accutane had warnings about the drug potentially causing birth defects and warnings to patients and medical providers that women who are pregnant or about to get pregnant should not take the drug, it is thought that birth defect cases will probably not be viable against the makers of Accutane.

However, Plaintiffs that have suffered severe inflammatory bowel disease after taking Accutane and were taking the drug prior to the risk being added to the warning label may have viable claims. This is because the drug manufacturer did not warn those outside the company of known serious risks of taking the drug. Plaintiffs that have suffered inflammatory bowel disease (IBD) including Crohn’s Disease and Ulcerative Colitis and took Accutane prior to the warning label changes are expected to have viable cases because it is thought that some of the manufacturers of Isotretinoin hid known health risks of the drug from medical doctors and the public in order to increase their revenues and profits.

Additionally, there are potential off label marketing issues where patients were given Isotretinoin when they did not have severe acne. These issue may impact the viability of potential cases if it is proven that the manufacturers provided false and misleading information to medical providers for the purpose of selling more of the drug.

Accutane Ulcerative Colitis Lawyers, Isotretinoin Crohn's Disease Lawyers, and Accutane Inflammatory Bowel Disease (IBD) Lawyers (Isotretinoin Ulcerative Colitis and Accutane Crohn's Disease Lawsuits)

For more information on Accutane Inflammatory Bowel Disease (IBD) Lawsuits and Accutane Inflammatory Bowel Disease (IBD) lawyers feel free to go to the following web page on Isotretinoin and Accutane Inflammatory Bowel Disease (IBD) Lawsuits.

Lyrica (Pregabalin) Off-label Use Suicide and Attempted Suicide Lawsuits

2010-04-22T16:45:00.000-07:00

Lyrica Off-label Use Suicide and Attempted Suicide Lawsuits
(by Pregabalin Off-label Use Suicide Lawyer Jason Coomer)

Lyrica (Pregabalin) is a derivative of the drug Neurontin. Nuerontin has been aggressively marketed for many off-label uses and Lyrica has been also. Some of the off-label uses of the drugs include pain relief, migraine headaches, neuropathic pain, nystagmus, Complex Regional Pain Syndrome, mood-stabilizing treatment for bipolar disorder, menopausal hot flashes, and idiopathic subjective tinnitus. The FDA has recently issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking pregabalin.

Lyrica Approved Uses, FDA Actions, and FDA Warnings
(Pregabalin Suicide Lawsuits)

Lyrica (pregabalin) is a prescription medication approved for the treatment of the following conditions:

Diabetic peripheral neuropathy -- Lyrica is approved to be used for the treatment of nerve pain associated with Diabetic Peripheral Neuropathy
Epilepsy -- Lyrica is approved to be used with other medication for the treatment of seizures called partial seizures
Fibromyalgia -- Lyrica is approved to be used in the treatment of fibromyalgia pain
Postherpetic neuralgia -- Lyrica is approved to be used in the treatment of nerve pain that occurs after an outbreak of shingles.

The U.S. Food and Drug Administration (FDA) issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking antiepileptic drugs (AED) including Lyrica (pregabalin). An independent analysis by the FDA showed that anticonvulsant drugs, including pregabalin, can increase suicidal thoughts in patients. The approved label for Lyrica now includes a warning about an increased risk of suicidal thoughts or actions and a guide to help patients understand this risk.

Off-Label Marketing of Lyrica, Off-Label Criminal Penalties & Civil Fines Paid by Pfizer, and Off-Label Marketing Lawsuits

The Federal Food Drug and Cosmetic Act (”FDCA”), provides a systematic scheme for the approval of new drugs and new drug formulations intended to be marketed for use in interstate commerce. Under the FDCA, a new drug product cannot be marketed unless the FDA approves the product and determines that it is safe and effective for its intended use. When the FDA approves a drug, it approves the drug only for the particular use for which it was tested, but after the drug is approved for a particular use, the FDCA does not regulate how the drug may be prescribed. Thus, a drug that has been tested and approved for one use only can also be prescribed by a physician for another use, known as “off-label.”

Though physicians may prescribe drugs for off-label usage, the FDA prohibits drug manufacturers from marketing or promoting a drug for a use that the FDA has not approved. A manufacturer illegally “misbrands” a drug if the drug’s labeling includes information about its unapproved uses. A drug is deemed misbranded unless its labeling bears adequate directions for use. The courts have agreed with the FDA that the FDCA requires information not only on how a product is to be used (e.g. dosage and administration), but also on all the intended uses of the product. Oral statements and materials presented at industry-support scientific and educational activities may provide evidence of a product’s intended use. If these statements or materials promote a use that is inconsistent with the product’s approved labeling, the product is misbranded under the FDCA for failure to bear labeling with adequate directions for all intended uses.

Lyrica is one of four drugs which a subsidiary of Pfizer in 2009 pleaded guilty to misbranding "with the intent to defraud or mislead". Pfizer agreed to pay $2.3 billion in settlement, and entered a corporate integrity agreement. Pfizer illegally promoted the drugs and caused false claims to be submitted to government healthcare programs for uses that were not medically accepted. For more information on Off-Label Marketing Fraud, go to the following web page on Off-Label Marketing Fraud.

Lyrica is basically a next generation drug of gabapentin. As the patents ran out on gabapentin (brand name Neurontin), Pfizer altered the medication slightly and created Lyrica (Pregabalin). Both drug have been aggressively marketed for many off-label uses including to relieve pain, migraine headaches, neuropathic pain, nystagmus, Complex Regional Pain Syndrome, mood-stabilizing treatment for bipolar disorder, menopausal hot flashes, and idiopathic subjective tinnitus. This off-label marketing for Lyrica and Neurontin is a serious problem in that the FDA has issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking Neurotin.

It is estimated that over 90 percent of Pfizer's revenue from Neurontin which is in the billions of dollars is from off-label use. Pfizer has paid a total of $2.75 billion in off-label penalties since 2004 which is a little more than 1 percent of the company’s revenue of $245 billion from 2004 to 2008. (Pfizer Broke the Law by Promoting Drugs for Unapproved Uses)

Pfizer continues aggressively marketing Lyrica and is enjoying expanding sales of this product to about $3 Billion annually. They continue to push for new approved uses through the FDA and were able to make Lyrica one of the first drugs approved for Fibromyalgia. This drug is being pushed through television advertisements and doctors, despite dangerous side effects. For more information on drug company aggressive marketing and pursuit of profits, go to the following web page: Economic Incentives for Drug Companies Lead to Aggressive Marketing of Defective & Ineffective Medications and Need for FDA Regulations, Checks on Drug Marketing, and Defective Drug Lawsuits.

FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior
for Antiepileptic Drugs AEDs

In December 2008, the U.S. Food and Drug Administration announced it will require the manufacturers of antiepileptic drugs to add to these products' prescribing information, or labeling, a warning that their use increases risk of suicidal thoughts and behaviors (suicidality). The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.

The FDA is also requiring the manufacturers to submit for each of these products a Risk Evaluation and Mitigation Strategy, including a Medication Guide for patients. Medication Guides are manufacturer-developed handouts that are given to patients, their families and caregivers when a medicine is dispensed. The guides will contain FDA-approved information about the risks of suicidal thoughts and behaviors associated with the class of antiepileptic medications.

"Patients being treated with antiepileptic drugs for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. " Patients who are currently taking an antiepileptic medicine should not make any treatment changes without talking to their health care professional."

The FDA today also disseminated information to the public about the risks associated with antiepileptic medications by issuing a public health advisory and an information alert to health care professionals. Health care professionals should notify patients, their families, and caregivers of the potential for an increase in the risk of suicidal thoughts or behaviors so that patients may be closely observed.

The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent). This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo.

Four of the patients who were randomized to receive one of the antiepileptic drugs committed suicide, whereas none of the patients in the placebo group did. Results were insufficient for any conclusion to be drawn about the drugs' effects on completed suicides. The biological reasons for the increase in the risk for suicidal thoughts and behavior observed in patients being treated with antiepileptic drugs are unknown.

The FDA alerted health care professionals in January 2008 that clinical trials of drugs to treat epilepsy showed increased risk of suicidal thoughts and actions. In July 2008, the FDA held a public meeting to discuss the data with a committee of independent advisors. At that meeting the committee agreed with the FDA's findings that there is an increased risk of suicidality with the analyzed antiepileptic drugs, and that appropriate warnings should extend to the whole class of medications. The panel also considered whether the drugs should be labeled with a boxed warning, the FDA's strongest warning. The advisers recommended against a boxed warning and instead recommended that a warning of a different type be added to the labeling and that a Medication Guide be developed.

Acting under the authorities of the Food and Drug Administration Amendments Act of 2007 (FDAAA), the FDA is requiring manufacturers of antiepileptic drugs to submit to the agency new labeling within 30 days, or provide a reason why they do not believe such labeling changes are necessary. In cases of non-compliance, FDAAA provides strict timelines for resolving the issue and allows the agency to initiate an enforcement action if necessary.

The following antiepileptic drugs (AEDs) are required to add warnings about the risk of suicidality:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal)
Phenytoin (marketed as Dilantin)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Rufinamide (marketed as Banzel)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Valproic Acid (marketed as Depakene, Stavzor Extended Release Tablets)
Zonisamide (marketed as Zonegran)

Neurontin and Lyrica Suicide Lawsuits (Gabapentin and Pregabalin Suicide Lawyers)

In 2009, the first cases against Pfizer, the maker of Neurontin, began going to trial, and there are an estimated 1200 pending cases regarding the safety of Neurontin. Although a Pfizer spokesperson noted that "the reliable scientific evidence does not demonstrate a causal association between Neurontin treatment and suicidal behavior," the FDA analysis found an 80 percent rise in suicidal thoughts and behavior in data from 199 studies of gabapentin and other anticonvulsants.

In March 2010, a jury awarded $140 million in a Neurontin case. Many more Neurontin cases are pending and are moving to trial. Additionally, it is expected that Lyrica Suicide cases are going to filed in the near future and start going to trial in the future.

For more information on Neurontin (Gabapentin) and Lyrica (Pregabalin) Lawsuits, please go to the following web page on Lyrica (Pregabalin), Antiepileptic Drugs (AED), and Neurontin (Gabapentin) Suicide Lawsuits.

Reglan and GERD Tardive Dyskinesia Lawyer (Drug Reactions)

2010-02-19T14:00:00.001-08:00

Tardive Dyskinesia Lawsuits (Neuroleptic Drug Reactions)

Tardive dyskinesia is a neurological disorder that exhibits itself through repetitive, involuntary, & purposeless movements like grimacing; tongue protrusion; lip smacking, puckering & pursing; and rapid eye blinking. Victims of tardive dyskinesia also can exhibit rapid & involuntary movements of the arms and legs. The neurological disorder is usually caused by the long-term and/or high-dose use of dopamine antagonists, usually antipsychotics and among them especially the typical antipsychotics. These neuroleptic drugs are generally prescribed for psychiatric disorders by psychiatrists.

If you or someone you love has been given high doses of neuroleptic drugs by a psychiatrist and has exhibited Tardive Dyskinesia symptoms, mkae sure that you get this person to a proper medical doctor, then feel free to submit an inquiry or send an e-mail to Texas Tardive Dyskinesia lawyer Jason Coomer. He may be able to help you recover your damages.

Reglan and GERD Tardive Dyskinesia Lawyer (Drug Reactions)

The symptoms a person can experience from Tardive Dyskinesia can vary from mild barely noticeable facial ticks and involuntary movements to severe problems. Severe cases of Tardive Dyskinesia can have a significant impact on a person's life disabling them from normal functioning. Severe facial ticks and involuntary body movements can be extremely embarrassing cause a person to withdraw from social interactions.

Older typical antipsychotics appear to cause tardive dyskinesia more often than the newer atypical antipsychotics. Haldol® is an older typical antipsycotic and has been linked to tardive dyskinesia. Other dopamine antagonists that can cause tardive dyskinesia are drugs for gastrointestinal disorders ( metoclopramide ) and neurological disorders. In addition to the dopamine antagonists that cause tardive dyskinesia other drugs that are not intended to affect dopamine, such as SSRI antidepressants, may also cause tardive dyskinesia. Newer atypical antipsychotics such as olanzapine and risperidone appear to also cause tardive dyskinesia, but somewhat less frequently.

FDA Requires Boxed Warning for Reglan and other Metoclopramide Containing Drugs (Tardive Dyskinesia GER and GERD Lawsuits)

On February 26, 2009, the U.S. Food and Drug Administration announced that manufacturers of metoclopramide, a drug used to treat gastrointestinal disorders, must add a boxed warning to their drug labels about the risk of its long-term or high-dose use. Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.

Manufacturers are required to implement a risk evaluation and mitigation strategy, or REMS, to ensure patients are provided with a medication guide that discusses this risk.

The FDA wants patients and health care professionals to know about this risk so they can make informed decisions about treatment, said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. The chronic use of metoclopramide therapy should be avoided in all but rare cases where the benefit is believed to outweigh the risk.

Current product labeling warns of the risk of tardive dyskinesia with chronic metoclopramide treatment. The development of this condition is directly related to the length of time a patient is taking metoclopramide and the number of doses taken. Those at greatest risk include the elderly, especially older women, and people who have been on the drug for a long time.

Tardive dyskinesia is characterized by involuntary, repetitive movements of the extremities, or lip smacking, grimacing, tongue protrusion, rapid eye movements or blinking, puckering and pursing of the lips, or impaired movement of the fingers. These symptoms are rarely reversible and there is no known treatment. However, in some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.

Metoclopramide works by speeding up the movement of the stomach muscles, thus increasing the rate at which the stomach empties into the intestines. It is used as a short-term treatment of gastroesophageal reflux disease in patients who have not responded to other therapies, and to treat diabetic gastroparesis (slowed emptying of the stomach's contents into the intestines). It is recommended that treatment not exceed three months.

Metoclopramide is available in a variety of formulations including tablets, syrups and injections. Names of metoclopramide-containing products include Reglan Tablets, Reglan Oral Disintegrating Tablets, Metoclopramide Oral Solution, and Reglan Injection. More than two million Americans use these products.

Recently published analyses suggest that metoclopramide is the most common cause of drug-induced movement disorders. Another analysis of study data by the FDA showed that about 20 percent of patients in that study who used metoclopramide took it for longer than three months. The FDA has also become aware of continued spontaneous reports of tardive dyskinesia in patients who used metoclopramide, the majority of whom had taken the drug for more than three months.

Reglan Tardive Dyskinesia Lawsuits (GER and GERD Malpractice)

Gastroesophageal reflux disease (GERD) is a more serious form of gastroesophageal reflux (GER), which is common. GER occurs when the lower esophageal sphincter (LES) opens spontaneously, for varying periods of time, or does not close properly and stomach contents rise up into the esophagus. GER is also called acid reflux or acid regurgitation, because digestive juices—called acids—rise up with the food.

When acid reflux occurs, food or fluid can be tasted in the back of the mouth. When refluxed stomach acid touches the lining of the esophagus it may cause a burning sensation in the chest or throat called heartburn or acid indigestion. Occasional GER is common and does not necessarily mean one has GERD. Persistent reflux that occurs more than twice a week is considered GERD, and it can eventually lead to more serious health problems. People of all ages can have GERD.

An estimated two-thirds of all infants suffer from GER, though the pathological condition called GERD (gastroesophageal reflux disease) affects approximately only one in 300 babies.

Reglan is a neuroleptic medication used to treat gastrointestinal problems that have had many cases of Tardive Dyskinesia reported in response to it. Reglan is supposed to increase the stomach and small intestine contractions to help the passage of food. As every medication, Reglan has side effects associated to it and some of them are very serious. In February 1996, the FDA warned that Reglan causes an increased risk of Parkinsonism.

Reglan is a dopamine antagonist that increases lower esophageal sphincter pressure and improves gastrointestinal emptying. The FDA approved Reglan, which is manufactured by Baxter Healthcare Corporation, for short-term treatment (between 4 and 12 weeks) of these conditions only after conservative methods of treatment have failed. However, it is common that patients are prescribed Reglan for longer than 12 weeks, which is against FDA recommendations.

This is problematic because prolonged use of Reglan can cause Tardive Dyskinesia, a serious and often irreversible movement disorder. Infants who are given Reglan appear to be at an even greater risk for this serious drug side effect.

Tardive Dyskinesia Lawsuits (Drug Reaction Lawsuits)

Using neuroleptic or anti-psychotic medication is believed to be the leading cause of tardive dyskinesia. These drugs are typically prescribed to treat psychiatric disorders such as schizophrenia by psychiatrists. The class of drugs known as first generation antipsychotics, including Haldol, is believed to pose the greatest risk of tardive dyskinesia. The newer atypical or second-generation antipsychotics, such as Risperdal or Geodon, appear to be safer but may still cause tardive dyskinesia. Additional medications that are prescribed to treat certain neurological and gastrointestinal disorders, such as Reglan, may also be linked to tardive dyskinesia.

There is no cure or customary treatment for tardive dyskinesia. Stopping the use of the medication or switching to another drug does not guarantee that the symptoms will improve or disappear. It can also be dangerous to immediately stop the use of the drug and advice of a medical doctor should be sought when making this determination. Even after discontinuing use of the offending drug, the damage may have already been done and tardive dyskinesia symptoms may remain well after use of the drug has ended.

Texas Tardive Dyskinesia Lawyer (Drug Reactions)

If you or someone you love is suffering from tardive dyskinesia, Austin Texas Tardive Dyskinesia lawyer, Jason S. Coomer, helps individuals that have been injured from high doses or long term use of neuroleptic medications. If you have a question about a anti-psychotic medication or other neurological or gastrointestinal medications that may have caused Tardive Dyskinesia, contact Austin Texas Tardive Dyskinesia Lawyer Jason Coomer.

He works with other Texas Psychiatrist Malpractice Lawyers including Houston psychiatrist malpractice lawyers, Dallas Psychiatrist Malpractice Lawyers, San Antonio Psychiatrist Malpractice Lawyers, and other Austin Psychiatrist Negligence Lawyers on a variety of psychiatrist malpractice claims.

Neurontin Off-label Use Suicide and Attempted Suicide Lawsuits

2010-01-18T08:56:00.000-08:00

Neurontin Off-label Use Suicide and Attempted Suicide Lawsuits
(Gabapentin Off-label Use Suicide Lawyer)

Gabapentin (brand name Neurontin) is a GABA analogue. It was originally developed for the treatment of epilepsy, but has been aggressively marketed for many off-label uses including to relieve pain, migraine headaches, neuropathic pain, nystagmus, Complex Regional Pain Syndrome, mood-stabilizing treatment for bipolar disorder, menopausal hot flashes, and idiopathic subjective tinnitus. The FDA has issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking gabapentin.

Neurontin FDA Actions and Warnings (Gabapentin Suicide Lawsuits)

The U.S. Food and Drug Administration (FDA) has issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking gabapentin. An independent analysis by the FDA showed that anticonvulsant drugs, including gabapentin, can increase suicidal thoughts in patients. The approved label for Neurontin now includes a warning about an increased risk of suicidal thoughts or actions and a guide to help patients understand this risk.

FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications Including Neurontin

The following antiepileptic drugs are required to add warnings about the risk of suicidality:

Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR
Clonazepam (marketed as Klonopin)
Clorazepate (marketed as Tranxene)
Divalproex sodium (marketed as Depakote, Depakote ER)
Ethosuximide (marketed as Zarontin)
Ethotoin (marketed as Peganone)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Lacosamide (marketed as Vimpat)
Levetiracetam (marketed as Keppra)
Mephenytoin (marketed as Mesantoin)
Methosuximide (marketed as Celontin)
Oxcarbazepine (marketed as Trileptal)
Phenytoin (marketed as Dilantin)
Pregabalin (marketed as Lyrica)
Primidone (marketed as Mysoline)
Rufinamide (marketed as Banzel)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Trimethadione (marketed as Tridione)
Valproic Acid (marketed as Depakene, Stavzor Extended Release Tablets)
Zonisamide (marketed as Zonegran)

Off-Label Marketing Claims and Off-Label Marketing Lawsuits

Gabapentin (brand name Neurontin) has been aggressively marketed for many off-label uses including to relieve pain, migraine headaches, neuropathic pain, nystagmus, Complex Regional Pain Syndrome, mood-stabilizing treatment for bipolar disorder, menopausal hot flashes, and idiopathic subjective tinnitus. This off-label marketing for Neurontin is a serious problem in that the FDA has issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking Neurotin.

For more information on Off-Label Pharmacy Practices, please feel free to go to the following Website on Medicare Fraud and False Claims Act Qui Tam Claims.

Neurontin Suicide Lawsuits (Gabapentin Suicide Lawyers)

In July 2009, the first case against Pfizer, the maker of Neurontin, went to trial, and there are an estimated 1200 pending cases regarding the safety of Neurontin. Although a Pfizer spokesperson noted that "the reliable scientific evidence does not demonstrate a causal association between Neurontin treatment and suicidal behavior," the FDA analysis found an 80 percent rise in suicidal thoughts and behavior in data from 199 studies of gabapentin and other anticonvulsants.

If you or a loved one have been taking Neurontin have attempted suicide, it is important to seek to medical assistance. For more information on a potential Neurontin lawsuit for the death of a loved one, please go to the following webpage on Neurontin Suicide Lawsuits or please feel free to e-mail Texas Neurontin Suicide Lawyer Jason Coomer with your name & contact information.

Yaz, Yasmin, and Ocella Birth Control Drug Gallbladder & Death Lawsuits

2009-11-24T18:00:00.000-08:00

Birth Control Medication Lawsuits (Yaz, Yasmin, and Ocella Birth Control Drug Lawsuits)

YAZ, Ocella, and Yasmin are oral contraceptives that produced over $1 Billion in sales in the United States and $1.8 Billion worldwide in 2008. These birth control pills are oral contraceptives that have been heavily marketed by Bayer HealthCare Pharmaceuticals, Inc., however, the FDA has found that past marketing campaigns were misleading as it minimized the potential health risks that have been associated with these oral contraceptives. These health risks include sudden death, cardiovascular problems, blood clots, heart attacks, stokes, and gallbladder disease.

Yaz, Yasmin, and Ocella Birth Control Medications Contain Drospirenone (DRSP) that has been Associated with Serious Health Risks

YAZ and Yasmin are combined oral contraceptive (COC) pills that contain ethinylestradiol (EE) and drospirenone (DRSP). These birth control medications are manufactured by Bayer HealthCare Pharmaceuticals, Inc., while Ocella is the generic equivalent of Yasmin that is manufactured by Barr Laboratories. Each of these birth control medications contain ethinyl estradiol and the new "fourth generation" progestin drospirenone (DRSP). Drospirenone is known for increasing the risk for hyperkalemia and these DRSP oral contraceptives have been associated with adverse health effects such as Death, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Strokes, Heart Attacks, Gallbladder Disease, and other health problems.

YAZ Marketing Campaign Created Annual Revenues of over $600 Million, but Overstated Drug Benefits and Understated Drug Dangers

The FDA has found that Bayer's marketing campaign that was directed at young women for the birth control drug, YAZ, was misleading. The misleading marketing campaign allowed YAZ to become the best-selling oral contraception pill in the United States with annual sales revenue of over $600 million in 2008, but understated the birth control medications' health risks.

Through the efforts of the FDA and several states' Attorney Generals, the manufacturer and marketer of the oral contraceptive YAZ was required to run a $20 million advertising campaign for the purpose of correcting previous YAZ marketing statements and will be required to submit all future YAZ ads for the next six (6) years to the FDA for screening.

The YAZ ads allegedly overstated the pill's ability to improve women’s moods and clear up acne, while not fully warning of the drug's potential serious side effect health risks including Death, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), Strokes, Heart Attacks, Gallbladder Disease, and other health problems.

Recent FDA and Attorney Generals Take Action to Correct the YAZ Marketing Campaign Making Sure Bayer Does Not Understate Drug Dangers and Risks

In October 2008, the FDA took action against Bayer sending a warning letter to Bayer saying that two television ads overstated the drug’s benefits while understating its risks. The FDA warning letter stated that two 60 second direct to consumer broadcast television advertisements entitled "Not Gonna Take it" and "Balloons" submitted by Bayer HealthCare Pharmaceuticals, Inc. were "misleading because they broaden the drug's indication, overstate the efficacy of YAZ, and minimize serious risks associated with the use of the drug". Further, that these televisions advertisements "misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act".

The FDA had approved YAZ as a birth control pill that has a side benefit in treating a very specific mood-related psychological problem called "premenstrual dysphoric disorder" and improving moderate acne, however, Bayer overstated the drug's efficacy and minimized its potential dangers.

FDA Action against Yasmin for Minimizing Health Risks in 2003 Suggests Bayer May Have Had Prior Knowledge of Misleading Marketing that Minimized YAZ Health Risks

The contraceptive medication, YAZ, closely resembles another birth control medication, Yasmin. Both drugs contain contain ethinyl estradiol and the "fourth generation" progestin drospirenone (DRSP). Yasmin has been the subject of a similar FDA warning letter in 2003 that warned the manufacturer and marketer that their marketing advertisements were understating potential health risks and overstating the benefits of the birth control medication. At that time Yasmin was manufactured and marketed by Berlex Laboratories.

In 2006, Bayer HealthCare Pharmaceuticals, Inc. acquired Berlex Laboratories. Bayer now markets both oral contraceptives, YAZ and Yasmin which had sales of about $1.8 Billion in 2008.

Health Risks Related to the Oral Birth Control Mediations
Yaz, Yasmin, and Ocella

YAZ, Yasmin, and Ocella contain drospirenone (DRSP), a synthetic progestational compound that can cause serious side effects and has been associated with serious health problems including formation of dangerous blood clots, strokes, pulmonary embolisms (PE), gallbladder disease, deep vein thrombosis (DVT), heart attacks, and sudden death. Yaz and Yasmin are combined oral contraceptive (COC) pills that contain ethinylestradiol (EE) and drospirenone (DRSP). Both have been linked to blood clots and cardiovascular events as well as other serious health risks.

While it has long been known that taking a combined oral contraceptive (COC) pill with a combination of estrogen and a progestin hormone can increase the risk of stroke and blood clots in the legs and lungs, the health risks of newer synthetic should have been deceptively marketed as having less health risks with other benefits that the contraceptives do not have.

In October 2008, the Food and Drug Administration (FDA), concerned with the improper advertising of the YAZ/Yasmin/Ocella birth control drugs, issued a warning letter to the Bayer Corporation to cease unlawful promotion. Also, women who have taken these popular oral contraceptives reported serious side effects, including blood clots, stroke, gallbladder complications and heart attack as a result of taking the drugs.

It is thought that these birth control medications contain hormones the effect cholesterol metabolism and excretion into the gallbladder thereby affecting the cholesterol concentration and crystallization of bile acids in the secretions leading to gall stones as well as can lead to clots, strokes, or heart attacks.

For more information on YAZ/Yasmin/Ocella birth control drug Gallbladder Disease and Death Lawsuits, please go to the following YAZ Yasmin Ocella Lawsuit Website.

SSRI Birth Defect Lawsuits, Primary Pulmonary Hypertension (PPH) Lawsuits, Persistent Pulmonary Hypertension in Newborns (PPHN) Lawsuits, and Prozac, Zoloft and Paxil Lawsuits

2009-10-09T15:29:00.000-07:00

SSRI Birth Defect Lawsuits, Primary Pulmonary Hypertension (PPH) Lawsuits, Persistent Pulmonary Hypertension in Newborns (PPHN) Lawsuits, and Prozac, Zoloft and Paxil Lawsuits

Women that have taken SSRI antidepressants such as Prozac, Zoloft, and Paxil during pregnancy may be at a increased risk of their children having birth defects and health problems. Recent studies have been linked SSRI Antidepressants to birth defects and other health problems in babies including persistent pulmonary hypertension in newborns (PPHN) or developing a lung disorder, primary pulmonary hypertension (PPH). In a recent study published in the New England Journal of Medicine, women who took antidepressants in the third trimester delivered babies who were six times more likely to have persistent pulmonary hypertension of the newborn (PPHN) or developing a lung disorder, primary pulmonary hypertension (PPH) than babies not exposed to SSRIs.

If you or a loved one is taking a SSRI antidepressant during pregnancy or have had a child with primary pulmonary hypertension or other birth defects, it is important to seek medical assistance and advice. If you have questions about a potential SSRI Birth Defect Lawsuit, feel free to e-mail any questions you might have to toxicdose@texaslawyers.com.

SSRI Birth Defects, Primary Pulmonary Hypertension (PPH), Primary Pulmonary Hypertension of a Newborn, and other Potential Health Problems

Primary Pulmonary Hypertension (PPH) is a disorder of the lungs in which the arteries are severely restricted, causing the blood pressure in the pulmonary artery of the heart to rise to excessive levels. Blood flow is restricted and oxygen levels in the blood are suppressed.

Primary Pulmonary Hypertension (PPH) is a rare disease in the statistical sense, in that there are between one and two cases of Primary Pulmonary Hypertension (PPH) per million residents of the United States, which results in 300 new cases per year. However, recent studies show that Primary Pulmonary Hypertension (PPH) may be more prevalent than once thought as many cases have gone undiagnosed and the number of cases appear to be on the rise.

Persistent Pulmonary Hypertension in Newborns (PPHN) starts while the baby is in the womb. It is thought that the SSRI antidepressants effect the baby's natural development. During pregnancy circulation is handled by the placenta and does not go through the lungs, but after birth, the baby's circulation switches over from the ductus arteriosus (which now closes) to the lungs. However, in a baby born with Persistent Pulmonary Hypertension in Newborns (PPHN), the ductus arteriosus stays open and the baby's blood flow continues to bypass the lungs. Because the blood does not enter the lungs, it returns to the heart very low in oxygen causing serious health problems. The baby's organs, such as the brain, kidneys and liver quickly become stressed due to lack of oxygen. Persistent Pulmonary Hypertension in Newborns (PPHN) is usually diagnosed within 12 hours of delivery.

Persistent pulmonary hypertension of the newborn is a cardiopulmonary disorder characterized by systemic arterial hypoxemia secondary to elevated pulmonary vascular resistance with resultant shunting of pulmonary blood flow to the systemic circulation. This pathophysiologic syndrome has been variously described as: Persistent pulmonary vascular obstruction, Persistent fetal circulation, Pulmonary vasospasm, Neonatal pulmonary ischemia, Persistent transitional circulation.

Persistent pulmonary hypertension of the newborn (PPHN) is the result of elevated pulmonary vascular resistance to the point that venous blood is diverted to some degree through fetal channels (i. e. the ductus arteriosus and foramen ovale) into the systemic circulation and bypassing the lungs, resulting in systemic arterial hypoxemia.

This disorder can be classified into three forms dependent on the likely etiology of the pulmonary hypertension: PPHN associated with pulmonary parenchymal disease, such as hyaline membrane disease, meconium aspiration, or transient tachypnea of the newborn as the cause of alveolar hypoxia known as secondary PPHN or appropriate PPHN alveolar oxygen tension appears to be the major determinant of pulmonary artery vasoconstriction. PPHN with radiographically normal lungs and no evidence of parenchymal disease frequently called Persistent Fetal Circulation (PFC), or primary or inappropriate PPHN. PPHN associated with hypoplasia of the lungs most often in the form of diaphragmatic hernia associated with an anatomic reduction in capillary number in addition to the pathophysiology listed below.

FDA Information on SSRI Antidepressant Birth Defects, Primary Pulmonary Hypertension (PPH), Primary Pulmonary Hypertension of a Newborn, and other Potential Health Problems

A recent study on women who had been treated with antidepressant drugs that act as selective serotonin reuptake inhibitors (SSRIs) showed risks of SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant. The study, by Christina Chambers and others, was published on February 9, 2006 in The New England Journal of Medicine.

The finding of PPHN in babies of mothers who used a SSRI antidepressant in the second half of pregnancy adds to concerns coming from previous reports that infants of mothers taking SSRIs late in pregnancy may experience difficulties such as irritability, difficulty feeding and in very rare cases, difficulty breathing. In addition, the labeling for paroxetine (Paxil) was recently changed to add information about findings in an epidemiology study suggesting that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects (see FDA Public Health Advisory for Paxil dated December 8, 2005).

Women who are pregnant or thinking about becoming pregnant should not stop any antidepressant without first consulting their physician. The decision to continue medication or not should be made only after there has been careful consideration of the potential benefits and risks of the medication for each individual pregnant patient. If the decision is made to stop treatment with SSRIs before or during pregnancy, this should be done with a healthcare professional, according to the prescribing information for the drug, and patients should be observed closely in case their depression comes back.

SSRI Birth Defect Lawyers, Primary Pulmonary Hypertension (PPH) Lawyers, Primary Pulmonary Hypertension in Newborns (PPHN) Lawyers, and Prozac, Zoloft and Paxil Lawyers

Texas Primary Pulmonary Hypertension (PPH) Attorney Jason Coomer commonly works with other SSRI Birth Defect lawyers throughout Texas and the United States including Houston Primary Pulmonary Hypertension in Newborns (PPHN) Lawyers, Boston SSRI Antidepressant Birth Defect Lawyers, San Antonio Primary Pulmonary Hypertension in Newborns (PPHN) Lawyers, Dallas Defective Medication Lawyers, and other Austin Dangerous Drug Attorneys. By sharing information and working together, his law firm and other firms throughout Texas and the United States are able to provide better representation for there clients.

If you or a loved one is taking a SSRI antidepressant during pregnancy or took Zoloft, Paxil, Prozac, or another SSRI antidepressant drug during pregnancy and have had a child with primary pulmonary hypertension (PPH), Primary Pulmonary Hypertension in Newborns (PPHN), or other birth defects, it is important to seek medical assistance and advice. If you have questions about a potential SSRI Birth Defect Lawsuit, feel free to e-mail any questions you might have to toxicdose@texaslawyers.com.

Fentanyl Patch Lawsuits

2009-10-09T15:26:00.000-07:00

Fentanyl Patch Lawsuits

Fentanyl is a strong narcotic painkiller that is now commonly administered in a “patch.” The Fentanyl Patch is a preferred method of delivery because if the patch is properly designed, manufactured, and administered, the dosage of the drug can provide a consistent dose of the drug. However, recently there have been some recalls of potentially defective Fentanyl Patches as these defects can lead to overdoses resulting in death.

If you or a loved one have been injured or exposed to a damaged Fentanyl Patch seek medical assistance. If you or a loved one has suffered a serious injury or have lost a loved one as a result of a damaged Fentanyl Patch, feel free to e-mail any questions you might have to toxicdose@texaslawyers.com.

Fentanyl Patch Potential Health Problems

Fentanyl skin patches provide pain relief for many people who experience chronic pain, and who have been taking pain medications for long periods of time. However, the Food and Drug Administration (FDA) has posted a warning that deaths and other serious problems have resulted from accidental overdoses related to inappropriate use of the fentanyl patch.

The Fentanyl patch is applied to the skin and is designed to deliver fentanyl, a potent, strong opiate analgesic. The drug is slowly absorbed through the skin into the bloodstream and can relieve pain for up to three days from a single patch application.

Please keep in mind that after applying the first patch, it can take 12 to 18 hours to reach the peak of pain relief, with some early pain relief occurring at four to six hours after the first administration.

The FDA is investigating deaths and overdoses that have occurred with both brand-name and generic fentanyl patches. The brand Duragesic (fentanyl transdermal system), manufactured by Janssen L.P. of Titusville, N.J., was approved by the FDA in 1990. A generic version, manufactured by Mylan Laboratories Inc. of Canonsburg, Pa., was approved in 2005.

Fentanyl Patch Recall

On February 17, 2008, Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, announced that 14 lots of Fentanyl transdermal system CII patches sold in the United States by Actavis' subsidiary Actavis South Atlantic LLC were being voluntarily recalled from wholesalers and pharmacies as a precaution.

The recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States by Actavis South Atlantic LLC.

"The 14 lots of Fentanyl transdermal system patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Although unaware of any injuries resulting from this issue Actavis, as a precaution, is recalling these lots. As per the approved product labelling for Fentanyl transdermal system, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are leaking or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.

The lots covered by this recall are: 27261 (exp 05/09), 27317 (exp 05/09), 27318 (exp 06/09), 27319 (exp 06/09), 27391 (exp 06/09), 27409 (exp 06/09), 27475 (exp 07/09), 27476 (exp 06/09), 27488 (exp 06/09), 27514 (exp 07/09), 27536 (exp 07/09), 27537 (exp 08/09), 27538 (exp 08/09), 27545 (exp 07/09), covering the following strengths: 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr.

Please note: Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches are labelled with an Abrika Pharmaceuticals label, but the outer carton bears the Actavis logo with the following product names:

Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-18.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-18.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-18.

Anyone who has fentanyl patches labelled with an Abrika or Actavis label should check them for these lot numbers.

Affected patches should not be handled directly.

Anyone with Actavis Fentanyl transdermal system patches with the above listed lot numbers should call 1 877 422 7452.

Patients using fentanyl patches who have medical questions should contact their health-care providers.

This recall is being conducted with the knowledge of the Food and Drug Administration.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch."

Fentanyl Patch Lawyers

Texas Fentanyl Patch Attorney Jason Coomer commonly works with other Fentanyl Patch lawyers throughout Texas and the United States including Houston Fentanyl Patch Lawyers, Boston Fentanyl Patch Lawyers, San Antonio Fentanyl Patch Lawyers, Dallas Defective Medication Lawyers, and other Austin Dangerous Drug Attorneys. By sharing information and working together, his law firm and other firms throughout Texas and the United States are able to provide better representation for there clients.

Pharmacy Misfilled Prescription & Mistake Claims

2009-10-09T15:24:00.001-07:00

Pharmacy Misfilled Prescription & Mistake Claims

Pharmacy mistakes and misfilled prescriptions can cause devastating problems. From pharmacy technicians that have confused ear cleaner for eye drops to be given to an infant to mistaking one medication for another causing heart problems or death to a consumer, giving a person the wrong amount or type of medication can cause major problems.

If you have any questions about pharmacy mistakes, feel free to send an e-mail to pharmacy-mistake@toxicexposurelaw.com or submit an inquiry.

Many pharmacies are great and well run, but others try to cut costs and have underpaid and under trained pharmacy technicians handle too much in the prescription filling process. It often will take a pharmacist to recognize dangerous drug interactions or determine if similar medication names have been accidentally confused or switched. Also it is always good to have a qualified pharmacy with quality control procedures in effect to prevent mistakes in amount of a medication or type of a drug from being mixed up.

Unfortunately, pharmacy mistakes occur when pharmacists and pharmacy technicians get too busy or are just not paying attention. If you feel you have been seriously injured by pharmacy mistake or have lost a loved one due to a medication mistake, it is important to investigate the claim and make sure that it does not happen again.

Asbestos Exposure

2009-10-09T14:32:00.001-07:00

Asbestos Exposure

Asbestos products can be extremely dangerous and cause serious injuries, if someone you know has mesothelioma or other form of cancer related to Asbestos exposure it is important that they get the best medical care that they can find and that the source of their exposure is stopped. If you have any questions feel free to send an e-mail to toxicexposure@toxicexposurelaw.com or submit an inquiry through the online form on this page.

Information on Asbestos and Asbestos Products

The term "asbestos" describes six naturally occurring fibrous minerals, namely chrysotile, amosite, crocidolite, tremolite, anthophylitte and actinolite. When mined and processed, asbestos is typically separated into very thin bundles of fibers and then commonly mixed with a binder during processing.

Asbestos has been known to man for centuries and has been used in literally hundreds of products. Asbestos was used because it is strong, insulates well, and resists fire and corrosion. Common modern uses are as thermal pipe and boiler insulation, spray-applied fire proofing and sound proofing, floor coverings, ceiling tiles, roofing materials and "transite" pipe and sheeting.

In the United States, asbestos became widely used in the early 1900s and its use peaked during the 1950s, 1960s, and 1970s. Despite wide spread use of asbestos many asbestos manufacturers and industry insiders became aware of the serious health issues surrounding asbestos in the 1930s and 1940s, but kept the information secret from workers and from the public. In the 1970s the Federal government stepped in and regulated the use of asbestos products. It is also now commonly agreed that exposure to asbestos can cause mesothelioma, lung cancer, and other health problems.

Today despite being better regulated an estimated 1.3 million employees in construction and general industry face significant asbestos exposure on the job. Heaviest exposures occur in the construction industry, particularly during the removal of asbestos during renovation or demolition. Employees are also likely to be exposed during the manufacture of asbestos products (such as textiles, friction products, insulation, and other building materials) and during automotive brake and clutch repair work.

Asbestos Product Dumping

In addition to domestic exposure, some companies have taken asbestos products that cannot be sold in the United States and have sold the product in other countries. This product dumping of dangerous asbestos insulation, asbestos block, and other asbestos products can cause serious problems including mesothelioma, lung cancer, and other health problems. Texas companies that dump dangerous products in other countries and cause significant harm can sometimes be brought into the Texas courts to answer for their wrongful dumping and be made to pay money compensation for their wrongful acts.

If someone you know has mesothelioma or other form of cancer related to Asbestos exposure it is important that they get the best medical care that they can find and that the source of their exposure is stopped. If you have any questions feel free to send an e-mail to toxicexposure@toxicexposurelaw.com.

Texas Tardive Dyskinesia Lawyer (Drug Reactions)

2009-10-09T14:16:00.001-07:00

Texas Tardive Dyskinesia Lawyer (Drug Reactions)

Tardive dyskinesia can be caused by medical negligence in prescribing the wrong types of medication, the wrong dose or duration of a drug, or in misdiagnosing a medical condition. Tardive Dyskinesia is a neurological disorder that exhibits itself through repetitive, involuntary, & purposeless movements like grimacing; tongue protrusion; lip smacking, puckering & pursing; and rapid eye blinking. Victims of tardive dyskinesia also can exhibit rapid & involuntary movements of the arms and legs. The neurological disorder is usually caused by the long-term and/or high-dose use of dopamine antagonists, usually antipsychotics and among them especially the typical antipsychotics. These neuroleptic drugs are generally prescribed for psychiatric disorders by psychiatrists.

If you or someone you love has been given high doses of neuroleptic drugs including Reglan by a medical doctor and has exhibited Tardive Dyskinesia symptoms, mkae sure that you get this person to a proper medical doctor, then feel free to submit an inquiry or send an e-mail to Texas Tardive Dyskinesia lawyer Jason Coomer. He may be able to help you recover your damages.

Tardive Dyskinesia Lawsuits (Neurological Drug Reactions)

It is believed that certain drugs can cause Tardive Dyskinesia by affecting how nerve impulses are transmitted across gaps between nerve cells (synapses). They do this in part by blocking a chemical made by the body called dopamine. After a while, the nerves seem to become hypersensitive to dopamine. Stimulation by even a little bit of dopamine may cause the abnormal movements.

The medicines most commonly associated with Tardive Dyskinesia include:

Antipsychotic medicines used to treat schizophrenia and other psychoses. These are also known as neuroleptic medicines.
Levodopa or L-dopa, which is used to treat Parkinson's disease (although high doses of L-dopa may actually help control tardive dyskinesia).
Antiemetic medicines used to control nausea and vomiting.
Tricyclic antidepressants used to treat depression and other mood disorders.
Other medicines that block dopamine.

Reglan Tardive Dyskinesia Lawsuits (GER and GERD Malpractice)

An estimated two-thirds of all infants suffer from GER, though the pathological condition called GERD (gastroesophageal reflux disease) affects approximately only one in 300 babies.

Haldol Tardive Dyskinesia Lawsuits (Psychiatric Malpractice)

Texas Tardive Dyskinesia Lawyer (Drug Reactions)

He works with other Texas Medical Malpractice Lawyers including Houston medical and psychiatrist malpractice lawyers, Dallas Medical Malpractice Lawyers, San Antonio Psychiatrist Malpractice Lawyers, and other Austin Psychiatrist Negligence Lawyers on a variety of medical malpractice claims.

Chantix Lawsuits (Suicide Claims)

2009-10-09T13:48:00.000-07:00

Chantix Lawsuits (Suicide Claims)

Chantix is a stop smoking aid or smoking cessation medication that has been linked to mood and behavior changes in people that use the drug. These behavior changes include suicidal behavior and suicidal idealation. These changes are especially problematic when Chantix is used in combination with alcohol.

If you or a loved one have been taking Chantix have attempted suicide, it is important to seek to medical assistance. If you have questions regarding a potential Chantix lawsuit for the death of a loved one, please feel free to e-mail Texas Chantix Lawyer Jason Coomer with your name & contact information.

Chantix FDA Actions and Warnings (Suicide Claims)

The U.S. Food and Drug Administration (FDA) has issued a Public Health Advisory to alert health care providers, patients, and caregivers to new safety warnings concerning Chantix (varenicline), a prescription medication used to help patients stop smoking. Initially, the FDA had issued an Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.

After further investigation the FDA has determined based on adverse event reports that it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients.

Chantix was approved by FDA in May 2006 as a smoking cessation drug. Chantix acts at sites in the brain affected by nicotine and may help those who wish to stop smoking by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if users resume smoking.

In the Public Health Advisory and a Health Care Professional Sheet issued by the FDA, the FDA emphasized the following safety information for patients, caregivers, and health care professionals:

Patients should tell their health care provider about any history of psychiatric illness prior to starting Chantix. Chantix may cause worsening of current psychiatric illness even if it is currently under control. It may also cause an old psychiatric illness to reoccur. FDA notes that patients with these illnesses were not included in the studies conducted for the drug's approval.

Health care professionals, patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy.

Patients should immediately report changes in mood and behavior to their doctor.
Vivid, unusual, or strange dreams may occur while taking Chantix.
Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery.

FDA will continue to update health care professionals with new information from FDA's continuing review or if new information is received on Chantix and serious neuropsychiatric symptoms.

Chantix Lawsuit Lawyers

Texas Dangerous Drug Attorney Jason Coomer commonly works with other lawyers throughout Texas and the United States including Texas Chantix Lawyers, Houston Chantix Lawyers, Boston Chantix Lawyers, San Antonio Pharmaceutical Lawyers, Dallas Defective Medication Lawyers, and other Austin Dangerous Drug Claim Lawyers. By sharing information and working together, his law firm and other firms throughout Texas and the United States are able to provide better representation for there clients.

Texas Chantix Lawyer Jason Coomer also works on Avandia Lawsuits and other defective mediation lawsuits. If you or a loved one have or are taking Chantix and have had mood swings, suicidal thoughts, or attempted suicide consult your doctor. If you or a loved one has questions about a potential Chantix Lawsuit, feel free to e-mail any questions you might have to toxicdose@texaslawyers.com.

YAZ, Yasmin, Ocella Birth Control Drugs

2009-10-09T13:46:00.001-07:00

YAZ, Yasmin, Ocella Birth Control Drugs

If you or a loved one have been injured by YAZ, Yasmin, Ocella birth control drugs seek medical assistance. If you or a loved one has suffered a serious injury or have lost a loved one as a result of YAZ, Yasmin, Ocella birth control drugs, feel free to e-mail any questions you might have to toxicdose@texaslawyers.com.

2009-10-09T13:45:00.000-07:00

Diabetes Drug Avandia Claims

2009-10-09T13:09:00.000-07:00

Diabetes Drug Avandia Claims

Evidence recently confirmed that the Diabetes Drug Avandia causes an increased risk of heart attacks, strokes, and other health problems. There is evidence that both the Food and Drug Administration (FDA) and the drug producer Glaxo have been aware of the problems for quite a while.

If you have suffered a heart attack or serious heart damage and have been taking Avandia, please seek medical advice as soon as possible. If you have lost a person that you love from a heart attack and/or have questions about Avandia, please feel free to e-mail your questions about Avandia.

Avandia Research Confirms Diabetes Drug Causes Heart Problems

The New England Journal of Medicine recently confirmed that people using the diabetes drug Avandia have a 43 percent increase in heart attacks over people not using Avandia. If you review the research on Avandia, this should come as no surprise either to the Food and Drug Administration (FDA) or to Glaxo as animal studies done prior to its approval showed constant findings that Avandia caused damage to the heart of many animals. Within the first six years of approval there have now been over 689 cases of heart failure reported to the FDA in patients using the drug. In addition, there have been reports of other health problems including strokes, anemia, and other heart problems.

More recently, there have been numerous reports of visual abnormalities in the form of macular edema (swelling of part of the retina) and increases in several kinds of fractures in women. Despite prior knowledge of serious cardiac problems, the FDA has failed to require Glaxo to adequately warn about the dangers of this drug that should be, at best, a last-choice treatment for Type II diabetes. In addition to the accumulating evidence of the health risks of Avandia, many experts suggest that Avandia is not as effective as other diabetes drugs in controlling glucose by lowering blood sugar or hemoglobin A1C.

If you have questions about a heart attack that you think was caused by Avandia or you believe that you have suffered heart damage from Avandia, please feel free to e-mail your questions.

The ToxicDoseLaw.com Website was developed by Texas Dangerous Drug Attorney Jason Coomer. He is a Texas Avandia Lawyer who commonly works with other lawyers throughout the nation including Chicago Avandia Lawyers, Boston Avandia Lawyers, New York Avandia Attorneys, California Avandia Attorneys, Houston Avandia Lawyers, Oklahoma Pharmaceutical Lawyers, Dallas Defective Medication Lawyers, and other Texas Dangerous Drug Claim Lawyers. By sharing information and working together, his law firm and other firms throughout the nation are able to provide better representation for there clients. For more information on Texas Lawyer Jason Coomer, go to his Law Firm's Web Site.