The epilepsy drug suicide study was published in the most recent issue of the medical journal, Neurology. Researchers say that the study shows that people taking certain newer antiepileptic medications, including Keppra, Gabitril, and Sabril, were three times as likely to try to commit suicide than people not on any antiepileptic medications, or on several older classes of antiepileptic drugs.

Researchers looked at 44,300 patients in the United Kingdom who used epilepsy drugs between 1990 and 2005. They found that newer antiepileptics that also carried risks of depression were most likely to cause suicidal or self-destructive tendencies. Valproate-based drugs, like Depakote, and new low-depression drugs, such as Neurontin and Lamictal, appeared to have no increased risk of suicide, according to the study.

The research is an attempt to fill in the gaps by an FDA meta-analysis that led to a 2008 decision requiring all epilepsy drugs to carry a suicide risk warning. The meta-analysis did not identify which epilepsy drugs were most associated with suicide risk, and some experts were critical of the FDA for what they said was casting to wide a net with the all-encompassing warning.

An editorial published with the article warned that the researchers gleaned their results from a very small number of suicide cases. It also points out that epileptics taking the newer drugs may have more severe epilepsy, a group that is traditionally more suicide-prone.

The study’s findings contradict those of a study published in April in the Journal of the American Medical Association (JAMA) in which U.S. researchers found an increased risk of suicide among users of Neurontin, Lamictal, Trileptal, Gabitral and Depakote.

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.