Lamictal, Lyrica and other epilepsy drugs may get black box suicide warning

Yesterday, FDA officials proposed that epilepsy drugs receive a new “black box” warning about an increased risk of suicide and suicidal thoughts. Side effects of Lamictal, Lyrica, Topamax, Depakote and other similar anti-seizure drugs in the same class have been associated with an increased risk of suicide.

>>PRIOR POST (2/2/2008): FDA Indicates Epilepsy Drug Side Effects Associated with Suicide

Approximately 2.7 million people in the United States have epilepsy, which is a chronic neurological disorder. The FDA proposes that the new warnings be applied to 11 different drugs used to prevent seizures associated with the condition, including:

• Neurontin (gabapentin)
• Lamictal (lamotrigine)
• Lyrica (pregabalin)
• Trileptal (oxcarbazepine)
• Topamax (topiramate)
• Keppra (levetiracetam)
• Gabitril (tiagabine)
• Zonegran (zonisamide)
• Felbatol (felbamate)
• Depakote, Depakene, Depacon (valproate)
• Carbatrol, Equetro, Tegretol (carbamazepine)

In addition to seizures, the medications are also used to treat other conditions, such as migraines, nerve-pain disorders, bipolar disorder and other psychiatric diseases. The drugs generated sales of over $10 billion in the United States last year, making them the fifth best-selling class of drugs.

In January, the FDA issued an alert to healthcare providers about the increased suicide risk associated with epilepsy drug side effects. A review of about 200 different clinical studies involving nearly 44,000 individuals taking one of the epilepsy drugs or a placebo, found that users were twice as likely to experience suicidal behavior. The suicide problems include reports of self-inflicted death, suicide attempts, acts to prepare for suicide and documented thoughts of committing suicide.

An FDA Advisory Panel will meet Thursday to consider the proposal from FDA scientists and make a recommendation about whether the risk justifies a “black box” warning, which is the strongest warning that can be placed on a prescription medication. The FDA usually follows the recommendations of the panels of outside experts they convene, but they are not required to.

In addition to the epilepsy drugs, the FDA has identified several medications over the past nine months which could increase the risk of suicide, including the popular “quit-smoking” drug Chantix, and the asthma drug Singulair. In January, the drug regulator agency instituted a new policy which requires drug makers to examine whether patients become suicidal during clinical studies due to concerns about the risk.

SUICIDE SIDE EFFECT LAWSUITS

The lawyers at Saiontz & Kirk, P.A. are currently investigating potential Chantix lawsuits for suicides caused by the medication. The potential for legal claims are also being reviewed for the Epilepsy drug suicide side effects. If you, a friend or family member have suffered severe injury or death as a result of a suicide while taking Lamictal, Lyrica, Topamax, Depakote or one of the other antiseizure drugs in the same class, request a free consultation.

UPDATE: At the July 10, 2008 hearing, the FDA advisory panel did find that the epilepsy drugs carry an increased suicide risk, but did not believe a “black box” warning is necessary. The FDA will consider the recommendations of their advisory panel before taking any regulatory action.