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The FDA is requiring the manufacturers of 11 different epilepsy drugs, such as Lamictal, Lyrica, Topamax and Depakote, to warn about potential side effects that may increase the risk of suicide and suicidal thoughts.
About 2.7 million Americans have epilepsy, and the anti-seizure drugs generate sales of over $10 billion a year, making them the fifth best-selling class of medications in the United States.
FDA officials originally indicated earlier this year that the medications should carry a “black box” warning about the suicide side effects of the epilepsy drugs, which would be the strongest warning that can be placed on a prescription medication.
However, a panel of independent advisors to the FDA met in July 2008, and concluded that that a “black box” suicide warning was not appropriate.
In a statement released December 16, 2008, the FDA indicates that they have completed their analysis of data involving suicides and suicidal thoughts with the drugs used to treat epilepsy, psychiatric disorders and other conditions.
Based on their review, the FDA is requiring all manufacturers to add information about the risk of suicidal thoughts an actions to the Warning section of their labeling and to develop a Medication Guide which will be provided to patients receiving the drugs.
The 11 epilepsy drugs which will carry the new suicide warnings include: Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR); Felbamate (marketed as Felbatol); Gabapentin (marketed as Neurontin); Lamotrigine (marketed as Lamictal); Levetiracetam (marketed as Keppra); Oxcarbazepine (marketed as Trileptal); Pregabalin (marketed as Lyrica); Tiagabine (marketed as Gabitril); Topiramate (marketed as Topamax); Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon); and Zonisamide (marketed as Zonegran).
The FDA indicates that they have reviewed data from nearly 200 clinical trials, which indicate that those taking one of the epilepsy drugs are nearly twice as likely to experience suicidal behavior or thoughts when compared to those taking a placebo.
For every 500 patients treated with an antiepileptic drug, the FDA suggests that one additional suicide could be caused.
Healthcare providers have been asked to notify patients, their families and caregivers about the potential epilepsy drug suicide side effects, so that they can watch for unusual behavior or suicidal thoughts.