FDA Decides on Epilepsy Drug Situation

By Alex Garrel
13:53, July 13th 2008
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FDA Decides on Epilepsy Drug Situation

Although an advisory panel of the US Food and Drug Administration said certain epilepsy drugs may increase the patients’ suicide risk, the FDA rejected a proposal targeting the addition of warning labels on eleven such anti-seizure drugs.

The twenty members in charge with such decisions voted unanimously to reach the aforementioned resolution.

In January, the FDA talked about the possibility of placing new black box warnings after having received the results of a series of drug-oriented studies. The studies were carried out by comparing drugs to placebos. In the end it was found that people who had taken the real drugs presented a much higher the risk of suicidal behavior than those who had been given placebos.

Out of the 43,000 patients who took part in the study, 30 who were on epilepsy drugs had suicide attempts, while with placebos, there were only 6 such cases. Sadly, out of the 30, four completed the attempts.

The list of drugs the FDA has been keeping an eye on contains the following names: Carbamazepine (aka Carbatrol, Equetro, Tegretol, Tegretol XR), Felbamate (aka Felbatol), Gabapentin (aka Neurontin), Lamotrigine (aka Lamictal), Levetiracetam (aka Keppra), Oxcarbazepine (aka Trileptal), Pregabalin (aka Lyrica), Tiagabine (aka Gabitril), Topiramate (aka Topamax), Valproate (aka Depakote, Depakote ER, Depakene, Depacon) and Zonisamide (aka Zonegran).

These types of drugs are usually used for treating epilepsy, bipolar disorders, migraines and several other conditions. A January FDA announcement was advising patients not to modify medications without getting the doctor’s approval. FDA spokeswoman Sandy Walsh said doctors should be very careful with the way their patients’ "mood, behavior and actions" change.

Altogether this is a very delicate issue; some say that too concerning warnings may cause people to be switch or even stop the treatments they need. How things will evolve from this point on remains to be seen.



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