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 new documents released on Friday.
The decision comes ahead of the release of a highly anticipated new analysis that FDA reviewers said supported earlier findings that certain antidepressants can increase the risk of suicide in some children and teen-agers.
The new 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.
Despite the new analysis, the FDA remained cautious.
"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.
Still, the FDA said it planned to ensure new labeling for antidepressants would "reflect the most recent information" from the studies and analyses, although the specific wording had not been determined.
Drugs approved based on clinical trials of adults
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 Prozac is approved in the United States for children and teenagers.
The FDA grants patent extensions to drugmakers who test products in children, but the companies are not required to make that data public.
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.
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.
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.
The agency is holding another two-day public meeting in September to discuss the Columbia University study.
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.
The FDA is looking at studies of newer drugs including Prozac, Pfizer Inc.'s Zoloft, Forest Laboratories Inc.'s Celexa, Wyeth's Effexor, Bristol-Myers Squibb's Serzone, Solvay's Luvox, Akzo Nobel's Remeron, and three GlaxoSmithKline Plc's drugs -- Paxil, Wellbutrin and Zyban.
The FDA's documents can be found online.
