FDA Warns Of Suicide Risk In Epilepsy Drugs

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epilepsy.jpgThe agency posted a warning on its web site this afternoon about an increased risk of suicidal thoughts and behaviors associated with 11 drugs used to treat epilepsy and certain psychiatric disorders. The drugs include Pfizer’s Lyrica, which is approved for treating pain associated with diabetes and fibromyalgia; Johnson & Johnson’s Topamax, which is also approved to treat migraines; and Glaxo’s Lamictal.

“Patients who were treated for epilepsy, psychiatric disorders, and other conditions were all at increased risk for suicidality when compared to placebo, and there did not appear to be a specific demographic subgroup of patients to which the increased risk could be attributed. The relative risk for suicidality was higher in the patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions,” the FDA wrote.

After examining nearly 200 clinical trials, the FDA saw approximately twice the risk of suicidal behavior or ideation, or 0.43 percent, compared with 0.22 percent of patients receiving a placebo in studies involving about 44,000 patients. The increased risk was seen as early as one week after starting an anti-epileptic drug and continued through 24 weeks. The agency plans to discuss the data at an upcoming advisory committee meeting.

In a statement, Pfizer said it hasn’t identified any evidence an increased risk of suicide-related events in Lyrica or Neurontin based on a review of clinical studies and post-marketing reports. GlaxoSmithKline said they would work with the FDA to update Lamictal’s label if needed, and Johnson & Johnson said there is already a discussion about suicide attempts in the Topamax label. Novartis didn’t immediately return requests for comment, The Wall Street Journal reports.

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  1. [...] Do Epilepsy Drugs Increase Risk For Suicide? The agency posted a warning on its web site this afternoon about an increased risk of suicidal thoughts and behaviors associated with 11 drugs used to treat epilepsy and certain psychiatric disorders. The drugs include Pfizer’s Lyrica, which is approved for treating pain associated with diabetes and fibromyalgia; Johnson & Johnson’s Topamax, which is also approved to treat migraines; and Glaxo’s Lamictal.“Patients who were treated for epilepsy, psychiatric disorders, and other conditions were all at increased risk for suicidality when compared to placebo, and there did not appear to be a specific demographic subgroup of patients to which the increased risk could be attributed. The relative risk for suicidality was higher in the patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions,” the FDA wrote…..read entire story [...]

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