Texas Lawyers Blog


The Texas Lawyers Blog provides useful information on the law and Texas lawyers. For more information on this Blog or a legal topic, please feel free to submit an inquiry or send an e-mail message to blog@texaslawyers.com

Thursday, April 22, 2010

Antiepileptic Drug (AED) Topiramate andTopamax Suicide Lawsuits

Antiepileptic Drug (AEDs), Anticonvulsant Drugs, and Topamax FDA Warnings and Safety Alerts (Topiramate Suicide Lawsuits)

On May 5, 2009, the FDA mandated a new warning for Topamax and all anticonvulsant drugs. The antiepileptic drug (AED) class label changes mandated that Topamax and all anticonvulsant drugs update product labeling to include a warning about an increased risk of suicidal thoughts or actions. Further, these manufacturers were directed to develop a Medication Guide to help patients understand the risk of suicidal thoughts or actions caused by the antiepileptic drugs. These changes affected all approved AEDs including Topamax except those indicated only for short-term use.

The FDA approved advice to be given to healthcare professionals is that "epilepsy and other illnesses for which antiepileptic drugs are prescribed are associated with an increased risk of suicidal thoughts and behavior. If suicidal thoughts or behavior emerge during treatment with AEDs, the prescriber should consider whether these symptoms may be related to the illness being treated. All patients who currently are taking or starting on any antiepileptic drug for any indication should be monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression."

Since the FDA issued safety alerts for the antiepileptic drugs on December 16, 2008 and January 31, 2008, the FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk. As described in the January 31, 2008, Information for Health Care Professionals Sheet on AEDS, eleven antiepileptic drugs were included in FDA’s original pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.

Topamax Birth Defect Malformation Lawsuits and Cleft Lips or Palate Lawsuits (Topiramate Birth Defect Lawsuits)

The epilepsy and migraine drug Topamax has also been associated with an increased risk of birth defects for children of mothers that were taking the drug during pregnancy. Research studies have found that there are higher than expected rates of babies born with cleft lips, cleft palates, genital defects and other birth malformations when Topamax is used by women during pregnancy. Thus there is growing amounts of research that indicate that the use of the epilepsy and migraine drug, Topamax, either on its own or in combination with other epilepsy drugs, may increase the risk of birth defects when it is used during pregnancy.

Topamax and Topiramate FDA Approved Uses

Topamax (generic name: Topiramate) is an anticonvulsant drug also referred to as an antiepileptic drug (AED) that is produced by Ortho-McNeil Neurologics and Noramco, Inc., both divisions of Johnson & Johnson. Topamax was first approved by the Food and Drug Administration in 1996 to treat epilepsy. In 2010, Topamax is approved for use by itself or in combination with other meds to treat a variety of forms of epilepsy as well as to treat migraines.

Off-Label Uses of Topamax and Topiramate

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.

Topamax is also being marketed for several off-label uses. Some of the off-label uses of Topamax include for treatment of bipolar disorder, cluster headaches, eating disorders, obesity, fibromyalgia, depression, posttraumatic stress disorder (PTSD), alcoholism, sleep disorders, sleep-eating disorders, infantile spasms, autism, periventricular leukomalacia in preterm infants after an hypoxic-ischemic injury, essential tremor, bulimia nervosa, obsessive-compulsive disorder, smoking cessation, idiopathic intracranial hypertension, neuropathic pain, and cocaine dependence.

Topamax Suicide Lawsuits and Topiramate Suicide Lawyers

Topamax Topiramate Suicide Lawsuits are currently in the process of being filed in the United States. It is expected that several Topamax Suicide Lawsuits will be filed in 2010 and Multidistrict Litigation status will be sought by Topamax Lawyers. For more information on Topamax Lawyers and Lawsuits, please go to the following web page: Topamax Suicide Lawsuits Antiepileptic Drug Suicide Lawyer.

No comments: