Antidepressants need stronger warnings

1.00pm

BETHESDA - Antidepressant medications, including such best-selling drugs as Prozac and Paxil, should come with strong warnings that they appear to raise the risk of suicidal thoughts and behaviour in younger patients, a US advisory panel concluded on Tuesday.

The US Food and Drug Administration's panel of experts voted 15-8 to urge regulators to require "black box" warnings, the strongest type of warning the agency can use for prescription drugs.

Earlier in the meeting, the advisers concluded the use of antidepressants appears linked to a higher risk of suicidal behaviour in some children and teenagers.

The committee said evidence from two dozen clinical trials of nine of the newest antidepressants showed children treated with the drugs were more likely to report suicidal thoughts or actions. No suicides occurred during the trials.

"The purpose is to put physicians on notice that this group of medicines can cause problems," said panel member Dr. James McGough, a child and adolescent psychiatrist from Los Angeles.

Panel member Robert Gibbons, a statistician from the University of Illinois-Chicago, agreed there was a risk but stressed it was "very small."

A FDA analysis concluded two or three out of every 100 young people treated with antidepressants might be at higher risk of suicidal behaviour.

The panelists said the concern applied to all nine drugs studied, including Eli Lilly and Co.'s Prozac, GlaxoSmithKline Plc's Paxil and Wellbutrin, Pfizer Inc.'s Zoloft. Forest Laboratories Inc.'s Celexa, Wyeth's Effexor, Solvay SA's Luvox and Akzo Nobel NV's Remeron were also reviewed.

Bristol-Myers Squibb's Serzone was also included, but the company discontinued the drug earlier this year.

The panel also said the black box warnings should appear on older antidepressants such as tricyclics.

Data on suicidal behaviour varied among the drugs, but "we are unable to conclude any single agent is free from risk at this time," said Dr. Lauren Marangell, a psychiatrist from Baylor College of Medicine in Houston.

Millions of children are treated with various antidepressants, although only Lilly's Prozac is approved for treating pediatric depression.

The FDA first became aware of a possible link to suicide in May 2003. Critics charge the agency was slow to act and instead chose to discount the findings of one of its own researchers.

In March 2004 the FDA advised doctors and parents to watch for signs of worsening depression or suicidal thoughts in patients taking the newer antidepressants.

But British authorities had already told doctors last year to avoid prescribing most antidepressants to children because of worries over possible suicidal behaviour.

The FDA has committed to updating the drug labels, but has not said when they will make a final decision. The agency usually follows the advice of its advisory panels.

- REUTERS