Topiramate (brand name Topamax) is a anticonvulsant drug. It has been approved for the treatment of epilepsy and migraines, but has been aggressively marketed for many off-label uses including 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. In May of 2009, the FDA issued a warning of an increased risk of suicidal thoughts and behaviors in patients taking topiramate.
If you or a loved one have been taking Topamax and has attempted suicide or were taking Topamax during pregnancy and had a child with a birth defect, it is important to seek medical assistance. If you have questions regarding a potential Topamax lawsuit for the death of a loved one or birth defect, please feel free to e-mail Texas Topamax Suicide Lawyer Jason Coomer with your name & contact information. or to submit an inquiry through this submission form.
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, 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.
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 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)
Topamax Suicide Lawyers and Topiramate Suicide Attorneys
Texas Dangerous Drug Attorney Jason Coomer commonly works with other lawyers throughout Texas and the United States including Texas Topamax Lawyers, Houston Topiramate Lawyers, Boston Suicide Lawyers, San Antonio Pharmaceutical Lawyers, Dallas Off-label Topamax Lawyers, and other Austin Dangerous Drug Claim Lawyers. By sharing information and working together, his law firm and other firms throughout Texas and the United States are able to provide better representation for there clients.
Texas Topamax Lawyer Jason Coomer also works on Reglan Tardive Dyskinesia Lawsuits and other defective drug mediation lawsuits. If you or a loved one have or are taking Topamax or another Antiepileptic Drug (AED) and have had suicidal thoughts, or attempted suicide consult your doctor. If you or a loved one has questions about a potential antiepileptic drug (AED) or Topamax Suicide or Attempted Suicide Lawsuit, feel free to e-mail any questions you might have to TopamaxLawyer@texaslawyers.com.