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. 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. 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. Despite the 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 labeling for antidepressants would "reflect the most recent information" from the studies and analyzes, although the specific wording had not been determined. 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 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, informs Reuters. According to Bloomberg, antidepressant drugmakers such as Pfizer Inc., GlaxoSmithKline Plc and Wyeth will have to disclose trial results suggesting a higher risk of suicide among children and teenagers taking the pills, U.S. regulators said. The Food and Drug Administration will require companies to include the information on labels for depression drugs, used by more than 1 million Americans under age 18, according to a study by pharmacy-benefit manager Express Scripts Inc. The agency has been examining the potential risk since it warned last year against any use of Glaxo's Paxil in children and teenagers, citing reports of suicide attempts and thoughts. U.S. regulators moved after New York Attorney General Eliot Spitzer accused Brentford, U.K.-based Glaxo, Europe's largest drugmaker, of hiding study data suggesting Paxil might increase the risk of suicide among children. The American Medical Association on June 15 asked the U.S. to require drugmakers to disclose all study results. Shares of New York-based Pfizer, the world's biggest drugmaker, rose 26 cents, or less than a percent, to $31.74 as of 4:16 p.m. in New York Stock Exchange composite trading. Pfizer makes the antidepressant Zoloft, the top-selling antidepressant last year with sales of $3.1 billion. ``Our sense is that this will continue to be a topic of ongoing interest between now and the hearing, and we believe the hearing will do a lot to move the issue forward,'' said Susan Bro, a Pfizer spokeswoman. About 1.3 million children and teenagers who were covered by insurance took antidepressants in 2002, said Thomas Delante, who conducted a study for Maryland Heights, Missouri-based Express Scripts, the third-largest pharmacy-benefit manager. The percentage of all children and teenagers jumped by half to 2.4 percent from 1.6 percent in 1998, he said. ABCNEWS publishes, that the question is how strong the warnings will be, and whether any of the drugs will come with specific instructions not to use them in children and teenagers. The controversy erupted last year, when British health authorities declared that most popular antidepressants might sometimes increase the risk of suicidal behavior in children and teenagers. They declared all but one Prozac unsuitable for depressed youth, but stopped short of a pediatric ban. It's difficult to sort out because depression itself can lead to suicide, and studies show antidepressants can help adults recover. Here, only Prozac is FDA-approved to treat pediatric depression, and a taxpayer-funded study earlier this week showed that Prozac plus talk therapy was more effective for depressed teenagers than either approach alone. The latest FDA analyses don't link Prozac to increased suicidal tendencies. But while doctors widely prescribe antidepressants for children which is legal despite the lack of FDA approval there is little evidence that any other than Prozac work for pediatric depression, thus deepening concern about even potential risks.
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