Neurontin Off-label Use Suicide and Attempted Suicide Lawsuits

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

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 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

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.

 

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.

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)

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

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

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

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.  

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.

Pharmacy Misfilled Prescription & Mistake Claims

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

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)

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)

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.

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.

Haldol Tardive Dyskinesia Lawsuits (Psychiatric Malpractice)

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.

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 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.