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FDA Pushes Suicide Warning for Epilepsy Drugs

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The Food and Drug Administration (FDA) is urging that a new black box warning on suicide risks be added to the labels of 11 epilepsy drugs.

The FDA began investigating if epilepsy drugs posed any suicide risk in 2005. In doing so, the FDA analyzed almost 200 studies of 11 anti-seizure drugs, some that have been on the market for decades. The studies tracked almost 28,000 people given epilepsy medications and another 16,000 given dummy pills.

According to the FDA, 0.43 percent of drug-treated patients experienced suicidal thoughts or behavior, compared with 0.22 percent of placebo-takers. The higher risk of suicidal thoughts and behaviors was observed at one week after starting a drug and continued to at least 24 weeks. The results were generally consistent among all the different drug products studied and were seen in all demographic subgroups. Overall, 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.

In total, 11 epilepsy drugs could get the new black box warning – the FDA’s strongest safety notice. They 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)
  • Zonisamide (marketed as Zonegran)

According to the FDA, three of the 11 drugs studied showed no clear signal of suicidal problems. However, the agency is still leaning towards including the warning on all the drugs, as sample sizes in some of the studies might have been too small to accurately assess suicide risks.

The FDA is set to ask an outside advisory panel for its recommendations on the proposed black box at a meeting this Thursday. One of the issues the agency will ask the panel to address at Thursday’s meeting is whether all of the drugs, or just some of them, should be subjected to the black box. The FDA is not bound to follow the recommendations of its advisory panels, but it usually does so.

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