Another black box warning , belatedly. meanwhile omega 3 essential fatty acids – FISH OIL – is safe and effective. And cheap.
January 31, 2008: 03:23 PM EST
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration warned patients and health-care professionals Thursday about an increased risk of suicidal thoughts and behaviors associated with 11 drugs used to treat epilepsy and certain pyschiatric disorders.
The FDA said, in an alert posted to its Website, that it looked at nearly 200 clinical studies involving the 11 drugs and found a doubling of the risk of suicidal thinking or behavior. The drugs include Topamax by Johnson & Johnson ( JNJ), Lamictal by GlaxoSmithKline PLC (GSK), Pfizer Inc.’s (PFE) Lyrica, and Novartis AG’s (NVS) Tegretol and Trileptal. Topamax is also approved to treat migraine while Lyrica is approved to treat certain pain conditions from diabetes, shingles and fibromyalgia. The four companies either could not immediately comment on the FDA’s alert or didn’t immediately return requests for comment.
The FDA said patients receiving any of the 11 drugs had approximately twice the risk of suicidal behavior or ideation, or 0.43%, compared to 0.22% of patients receiving placebo in studies involving about 44,000 patients. The agency said increased risk was observed as early as one week after starting an anti-epileptic drug and continued through 24 weeks.
The agency also said patients currently on the drugs or starting treatment with the drugs “should be closely monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.”
The FDA said it would be working with manufacturers of the antiepileptic drugs to include the new information in product labeling. The FDA also said it planned to discuss the data at an upcoming advisory committee meeting.
The review looked at reports of suicidal behavior, which includes completed suicides, suicide attempts and preparatory acts and suicidal ideation or thinking about suicide that were seen in clinical studies of the drugs. The analysis included a total of 43,892 patients ages five and older with 27,863 in drug treatment groups and 16,029 in placebo groups or groups receiving fake drugs.
The FDA said four patients who were taking one of the antiepileptic drugs committed suicide compared to none of the patients in the placebo group.
The FDA said because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior that point could not be reliably assessed.
The review of suicidality data was similar to an earlier analysis of antidepressants, which resulted in the FDA’s toughest black-box warning being placed on those drugs in 2004 to warn about the risks of suidical behaviors and thoughts.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;