The Injectable Diabetes Drug Byetta May Cause Pancreatitis that May Lead to Pancreatic Cancer: Persons Taking Byetta Should Be Aware of Pancreatic Cancer Danger and Consult Their Physician Regarding Potential Pancreas Cancer Risks by Texas Byetta Pancreatic Cancer Lawyer, Byetta Pancreatitis Lawyer and Byetta Pancreas Cancer Lawyer Jason S. Coomer

The Injectable Diabetes Drug Byetta May Cause Pancreatitis that May Lead to Pancreatic Cancer: Persons Taking Byetta Should Be Aware of Pancreatic Cancer Danger and Consult Their Physician Regarding Potential Pancreas Cancer Risks by Texas Byetta Pancreatic Cancer Lawyer, Byetta Pancreatitis Lawyer and Byetta Pancreas Cancer Lawyer Jason S. Coomer

In November 2009, the FDA revised the prescribing information for Byetta to include information on reported cases of acute pancreatitis in patients using this drug.  This revision came after the FDA had received more than 30 reports of acute pancreatitis in Byetta users.  Based on these adverse reports, the FDA directed Amylin to conduct six post-marketing studies regarding acute pancreatitis associated with the use of Byetta, as well as to look at the risk of Byetta cancer, including thyroid cancer and pancreatic cancer. 

Pancreatic Cancer, Exocrine Pancreas Cancers (Pancreatic Adenocarcinoma) and Endocrine Pancreatic Cancers

Pancreatic cancer is the fourth leading cause of cancer death for both men and women and is one of the most deadly of all types of cancer. This year approximately 45,000 Americans will be diagnosed with pancreatic cancer and about 38,000 will probably die from it.

The most common kind of pancreatic cancer is pancreatic adenocarcinoma and includes about 90% of the cases of pancreatic cancer.  Pancreatic adenocarcinoma is a cancerous overgrowth of exocrine pancreatic cells and is unfortunately commonly undetected until it is too late for the patient.  Pancreatic adenocarcinoma because of late detection can often result a fatal diagnosis with very limited survival time. Other forms of exocrine pancreas cancer include: intraductal papillary mucinous neoplasm (IPMN), adenosquamous carcinomas, acinar cell carcinomas, mucinous cystadenocarcinomas, signet ring cell carcinomas, hepatoid carcinomas, colloid carcinomas, undifferentiated carcinomas, pancreatoblastomas, and undifferentiated carcinomas with osteoclast-like giant cells.

Unfortunately, pancreatic cancer is difficult to diagnose, and the diagnosis is often made late in the course of the disease.  Early detection of pancreatic cancer is essential and will greatly improve a person's chances of surviving the disease. As such, people that have taken Byetta, especially those with symptoms of weight loss, dark urine and clay-colored stools, back pain, and jaundice, should seek advice from a qualified medical professional as to if they may have pancreatic cancer and what symptoms they should be aware of to detect any early onset of pancreatic cancer.

Acute Pancreatitis, Hemorrhagic Pancreatitis, Necrotizing Pancreatitis 

Acute pancreatitis is a sudden inflammation of the pancreas that occurs over a short period of time. The pancreas is a digestive organ behind the stomach that secretes essential enzymes needed for the digestion of certain foods, including fats, carbohydrates and proteins. During an episode of acute hemorrhagic pancreatitis, several symptoms relating to digestion and abdomen may occur.  In severe cases, the person may experience confusion, difficulty breathing, or respiratory failure.  The person may also fall into a coma.

The severity of acute pancreatitis may range from mild abdominal discomfort to a severe, life-threatening illness. However, the majority of people with acute pancreatitis (more than 80%) recover completely after receiving the appropriate treatment.  In very severe cases, acute pancreatitis can result in bleeding into the gland, serious tissue damage, infection, and cyst formation. Severe pancreatitis can also create conditions which can harm other vital organs such as the heart, lungs, and kidneys.

The warning signs of pancreatitis include: 1) Upper abdominal pain that radiates into the back. Patients may describe this as a "boring sensation" that may be aggravated by eating, especially foods high in fat. 2) Swollen and tender abdomen 3) Nausea and vomiting 4) Fever  and 5) Increased heart rate.

Acute hemorrhagic pancreatitis is the sudden inflammation of the pancreas. This leads to death of pancreatic tissue and the formation of lesions, causing extensive bleeding. 

Necrotizing pancreatitis is a serious health condition where a person's pancreas is inflamed and bleeding. In Necrotizing Pancreatitis patients, there is inflammation and tissue death, with the pancreas destroying itself.  Whereas in Hemorrhagic Pancreatitis patients, the pancreas is bleeding.  Both are serious conditions and should be treated immediately.

Byetta Pancreatic Cancer Lawsuit Information, Byetta Pancreas Cancer Lawsuit Information, and Byetta Cancer Death Lawsuit Information

Byetta Pancreas Cancer Lawsuits and Byetta Pancreatic Cancer Lawsuits are in the process of being reviewed and filed as recent scientific evidence indicates that the injectable diabetes drug, Byetta (Exenatide), may cause an increased risk of pancreatitis, this side effect can and often does lead to the development of pancreatic cancer.  Pancreatic Cancer is an extremely deadly form of cancer.  Most people diagnosed with Pancreatic Cancer or Cancer of the Pancreas do not survive beyond the five years and many are given much less time as Pancreatic Cancer is hard to detect.  Early detection is the key to surviving pancreatic cancer.

Diabetics are more vulnerable to developing pancreatitis than those without the disease, recent studies indicate that taking Byetta can potentially increase the risk of pancreatitis. And, if pancreatitis becomes chronic, the inflammation of the pancreas will alter its normal structure and functions.  This can lead to pancreatic cancer. 

For more information on this topic, please feel free to go to the following web page: Byetta Pancreatic Cancer Lawsuit, Byetta Pancreas Cancer Lawsuit, and Byetta Cancer Death Lawsuit Information.

Increased Competition and Expansion in the Pharmaceutical Industry Creates Opportunity for Increased Corruption in Pharmaceutical Procement and Expands the Opportunity for Fraud in Pharmaceutical Drug Supply Chains that can create Dangerous Adulterated Drugs by International Adulterated Drug Whistleblower Lawyer and International Pharmaceutical Executive Whistleblower Reward Lawyer Jason S. Coomer

Increased Competition and Expansion in the Pharmaceutical Industry Creates Opportunity for Increased Corruption in Pharmaceutical Procement  and Expands the Opportunity for Fraud in Pharmaceutical Drug Supply Chains that can create Dangerous Adulterated Drugs by International Adulterated Drug Whistleblower Lawyer and International Pharmaceutical Executive Whistleblower Reward Lawyer Jason S. Coomer

Included in this globalization of the pharmaceutical industry is a shift in many international pharmaceutical manufacturing supply chains where raw material supplies for pharmaceuticals, medical supplies, and medical equipment that were traditionally from the United States and Europe are now produced in from China and India as well as other emerging countries.  This manufacturing shift create has created an environment where adulterated ingredients to pharmaceuticals, medical supplies, and medical devices may be used in the manufacturing of these products and can create dangerous and defective drugs, medical supplies, and medical devices being purchased by governments and given to patients. 

In the fiercely competitive medical device, medical supply, and pharmaceutical markets, there are strong economic incentives to search for the cheapest ingredients and methods to produce products.  Often these cheaper ingredients and manufacturing locations are in countries where standards and regulations are less stringent and corruption is more common.  When large corporations set up subsidiaries and joint venture partners in these countries, good manufacturing practices can often suffer, fraudulent actors can cut corners to reduce costs, and cheaper sometimes toxic materials can be added to the products.

Example of this scenario include the Baxter Heparin Recall in 2008 where Baxter, a US pharmaceutical firm which manufactures approximately 50% of the US heparin products, voluntarily recalled its heparin due to nearly 350 reported adverse events, including 19 deaths. In investigating this case, the USFDA revealed that the recalled heparin products contained a contaminated API. The tainted API, imported from Changzhou SPL China, contained a heparin-like contaminant that was structurally similar to heparin and not recognized in the solution until the FDA developed special testing for it. In March 2008, the FDA announced that they had identified the contaminant to be an altered form of an oversulfated chondroitin sulfate which is not a natural byproduct of the heparin manufacturing process. In April 2008, the US government held hearings and determined the cause to be non-sterile equipment, lack of following proper procedures, and lack of expertise.

Further, supply chains that are bigger and more complex present more opportunities for fraud.  As such, when a large corporation has a supply chain with several international subsidiaries and joint venture partners throughout the world, there are numerous opportunities along the supply chain for fraud to occur including supplier fraud, purchase order fraud, good manufacturing practices fraud, inventory fraud, documentation fraud, export fraud, import fraud, and other pharmaceutical fraud. 

International Whistleblowers along the pharmaceutical supply chain and other health care professionals are being offered large potential rewards to blow the whistle on adulterated pharmaceutical ingredients, adulterated medicine, adulterated drugs, contaminated medical supplies, and defective medical devices.  These whistleblower rewards can come from SEC Whistleblower Reward Lawsuits and traditional Qui Tam False Claims Act Whistleblower Reward Lawsuits.  For more information on these potential whistleblower rewards, feel free to go to the following web pages: International Adulterated Drug Supply Chain Whistleblower Reward Lawsuits and Drug Safety Fraud Qui Tam Adulterated Drug Whistleblower Reward Lawsuits.

Pradaxa Linked to Fatal Blood Loss, Internal Bleeding, and Hemorrhaging Deaths by Texas Pradaxa Fatal Blood Loss Lawyer, Pradaxa Hemorrhaging Death Lawyer, and Pradaxa Death Lawyer Jason S. Coomer

Pradaxa Linked to Fatal Blood Loss, Internal Bleeding, and Hemorrhaging Deaths by Texas Pradaxa Fatal Blood Loss Lawyer, Pradaxa Hemorrhaging Death Lawyer, and Pradaxa Death Lawyer Jason S. Coomer

 

Scientific evidence has recently confirmed that the the blood thinner, Pradaxa, may cause serious health problems including internal bleeding and hemorrhaging in certain populations of patients that may cause death.  Further, there are allegations that the drug manufacturer may have been aware of certain dangers of the drug's use, but did not warn the public in a timely manner of these health dangers.

Pradaxa Research May Lead to Pradaxa Internal Bleeding Lawsuits, Pradaxa Hemorrhaging Death Lawsuits, Pradaxa Internal Bleeding Death Lawsuits, and other Pradaxa Lawsuits

In September 2011, Pradaxa became the subject of an investigation in New Zealand after as many as five elderly Pradaxa patients reportedly died as a result of internal bleeding / hemorrhaging. Another 36 patients reportedly suffered bouts of serious internal bleeding / hemorrhaging. New Zealand media outlets reported that some families claimed the chain of events leading to their relatives' deaths began when they switched from warfarin to Pradaxa, and infections set in after their conditions had deteriorated to the point of hospital admission.

The New Zealand reports came weeks after regulators in Japan asked the maker of Pradaxa to notify doctors about potentially deadly bleeding / hemorrhaging in some Pradaxa patients. According to a letter sent to Boehringer Ingelheim by the country's health ministry, between March 14 and August11, 81 elderly patients taking Pradaxa suffered heavy bleeding / hemorrhaging, leading to five deaths. Japanese officials suggested that patients older than 70 may need a lower dose of Pradaxa. Bleeding / hemorrhaging is also a side effect of older blood thinners, such a warfarin. But warfarin bleeding can be treated with vitamin K. There is no antidote available for bleeding caused by Pradaxa and similar drugs, known as direct thrombin inhibitors. 

Please feel free to go to the following web page for more information on Pradaxa Internal Bleeding Death Lawsuit, Pradaxa Hemorrharing Death Lawsuit, and other Pradaxa Lawsuit Information.

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

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

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

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

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.