- WASHINGTON (Reuters) - The
U.S. Food and Drug Administration plans to update antidepressant labels
to reflect studies that suggest a link between the drugs and suicide in
youths, but remains cautious about the strength of such ties, according
to documents released on Friday.
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- The decision comes ahead of the release of a highly anticipated
analysis that FDA reviewers said supported earlier findings that certain
antidepressants can increase the risk of suicide in some children and teen-agers.
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- The review from Columbia University showed "a statistically
significant association of suicidal events with antidepressant drug treatment
in short-term pediatric clinical trials for all indications," said
FDA reviewer Dr. Andrew Mosholder in his analysis of the data posted on
the agency's Web site.
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- Despite the analysis, the FDA remained cautious.
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- "While there are some findings among these data
suggestive of an increased risk of suicidality for some of these drugs,
there remain some inconsistencies in the results," the agency said
in a separate statement.
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- Still, the FDA said it planned to ensure labeling for
antidepressants would "reflect the most recent information" from
the studies and analyzes, although the specific wording had not been determined.
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- Antidepressant use in younger patients is part of a larger
controversy over prescribing children medicines when most drugs are approved
based on clinical trials of adults. Only Eli Lilly and Co.'s (LLY.N: Quote,
Profile, Research) Prozac is approved in the United States for children
and teenagers.
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- The FDA grants patent extensions to drugmakers who test
products in children, but the companies are not required to make that data
public.
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- The FDA has been reviewing antidepressant data for months
but has yet to determine whether the widely used drugs raise the risk of
suicide in children and adolescents, and what regulatory action should
be taken.
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- Officials asked New York-based Columbia University to
analyze a number of existing studies to determine the level of risk. The
documents posted Friday did not include the school's actual study.
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- Mosholder, a scientist in the FDA's Office of Drug Safety,
had previously concluded the drugs posed a suicide risk but was not allowed
to present those results to an FDA advisory panel earlier this year. The
agency's refusal to allow Mosholder to present his findings is the subject
of congressional investigations.
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- The agency is holding another two-day public meeting
in September to discuss the Columbia University study.
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- In Britain, health officials have advised doctors that
except for Prozac they should not prescribe most selective serotonin re-uptake
inhibitors, or SSRI, antidepressants for children or adolescents.
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- The FDA is looking at studies of newer drugs including
Prozac, Pfizer Inc.'s (PFE.N: Quote, Profile, Research) Zoloft, Forest
Laboratories Inc.'s (FRX.N: Quote, Profile, Research) Celexa, Wyeth's (WYE.N:
Quote, Profile, Research) Effexor, Bristol-Myers Squibb's (BMY.N: Quote,
Profile, Research) Serzone, Solvay's (SOLBt.BR: Quote, Profile, Research)
Luvox, Akzo Nobel's (AKZO.AS: Quote, Profile, Research) Remeron, and three
GlaxoSmithKline Plc's (GSK.L: Quote, Profile, Research) drugs -- Paxil,
Wellbutrin and Zyban.
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- The FDA's documents can be found online at http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-
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