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Topamax and Zonegran can increase the risk of suicidal thoughts and behaviors according to the FDA
Wednesday, December 17, 2008 6:04 am Email this article
The U.S. Food and Drug Administration announced on Tuesday, December 16th, 2008 that it will require manufacturers of antiepileptic drugs, which includes Topamax (topiramate) and Zonegran (Zonisamide), to add a warning label that the use of these drugs use increases the risk of suicidal thoughts and behaviors.
The action includes all antiepileptic drugs including those used to treat psychiatric disorders, migraine headaches and other conditions, as well as epilepsy.
"The FDA's actions are based on the agency's review of 199 clinical trials of 11 antiepileptic drugs which showed that patients receiving antiepileptic drugs had almost twice the risk of suicidal behavior or thoughts (0.43 percent) compared to patients receiving a placebo (0.24 percent)," according to a press release from the FDA.
"This difference was about one additional case of suicidal thoughts or behaviors for every 500 patients treated with antiepileptic drugs instead of placebo."
Anon. FDA Requires Warnings about Risk of Suicidal Thoughts and Behavior for Antiepileptic Medications. 2008 Dec 16. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01927.html
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