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Epilepsy Drugs on the Way to get Suicide Warnings

Posted by Administrator (admin) on Jun 13 2008 at 5:15 PM
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The Food and Drug Administration (FDA) is almost finalizing new suicide warnings for 11 epilepsy drugs after a safety appraisal showed they increased patients’ risk of suicidal thoughts and behavior. Epilepsy is a disorder of the nervous system, characterized either by mild, episodic loss of attention or sleepiness or by severe convulsions with loss of consciousness.

The 11 epilepsy medicines slated for a new suicide warning are:

  • Carbamazepine (sold as Carbatrol, Tegretol, Equetro, Tegretol XR)
  • Felbamate (sold as Felbatol)
  • Gabapentin (sold as Neurontin)
  • Lamotrigine (sold as Lamictal)
  • Levetiracetam (sold as Keppra)
  • Oxcarbazepine (sold as Trileptal)
  • Pregabalin (sold as Lyrica)
  • Tiagabine (sold as Gabitril)
  • Topiramate (sold as Topamax)
  • Valproate (sold as Depakote, Depakote ER, Depakene, and Depacon)
  • Zonisamide (sold as Zonegran)

In addition to treating epilepsy, the anti-seizure drugs are used for a range of other diseases, including migraines, certain nerve-pain disorders, and psychiatric diseases such as bipolar disorder that themselves carry a suicide risk.

It was in 2005 that FDA started investigating whether epilepsy drugs poses any suicide risk. FDA analyzed just about 200 studies of 11 anti-seizure drugs. Some of those drugs have been on the market for decades. The studies tracked almost 28,000 people given epilepsy drugs and another 16,000 given dummy pills. Suicidal thoughts or behavior were experienced by 0.43 percent of drug-treated patients, compared with 0.22 percent of placebo-takers. In general, the results were consistent among all the different drug products studied and were seen in all demographic subgroups. On the whole, four people in the drug-treated groups committed suicide, and none in the placebo groups. For every 1,000 patients, about two more patients taking epilepsy drugs experienced suicidal thoughts than those who took placebo.


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