"MOOD STABILIZERS" Double the risk of suicide
Paragraph 7 reads: "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."
http://money.cnn.com/news/newsfeeds/articles/djf500/200801311523DOWJONESDJONLINE001003_FORTUNE5.htm
Epilepsy Drugs
January 31, 2008: 03:23 PM EST
(Updates throughout with details on specific drugs.)
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;
jennifer.corbett@dowjones.com
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