FDA urges young adult warning on antidepressants

Warnings on antidepressant drugs should be expanded to say the risks of suicidal thoughts and behavior extend to adults ages 18 to 24, U.S. health officials said on Wednesday.

The danger decreases, however, for adults 65 and older when they take the medicines, the Food and Drug Administration said. New warning labels should note that finding and stress that depression and some other psychiatric disorders are themselves a major causes of suicide, officials said.

The drugs already come with strong warnings that taking them may increase the chances of suicidal thoughts or actions in children and teenagers. Many psychiatrists have criticized the warnings, saying they scare people away from effective treatment and may have contributed to an increase in suicide in recent years.

Millions of Americans take antidepressants. The drugs include Wyeth's Effexor, Pfizer Inc.'s Zoloft, GlaxoSmithKline Plc's Paxil, Eli Lilly and Co's Prozac and Cymbalta, and Forest Laboratories Inc.'s Lexapro.

The FDA reviewed 295 studies of various antidepressants that included more than 77,000 adults.

The analysis found a "slight increase" in suicidal thinking and behavior among young adults during early treatment, which was generally the first one to two months, the FDA said. The data did not find a higher risk for adults older than 24.

For every 1,000 patients treated, about five more cases of suicidal thoughts and actions were reported among 18- to 24-year-olds who took the drugs rather than a placebo.

"The risk is quite small, but we think it is a real risk and it's something that needs to be paid attention to," Dr. Thomas Laughren, director of the FDA's division of psychiatry products, told reporters.

Fourteen additional cases were seen in patients under 18 who took antidepressants. For people 65 and older, there were six fewer cases.

Patients of any age who start taking antidepressants should be monitored for worsening depression, suicidal actions or unusual changes in behavior, FDA officials said. Anyone now taking one of the drugs should not stop, but should consult a doctor if they have concerns, they said.

Some psychiatrists have urged the FDA to remove or revise the warnings for children, which are highlighted in a "black box," the most serious type of warning for prescription drugs.

Prescriptions dropped after the warning for children and teens was added in 2004. The cautions about adults would be added to that warning.

The American Psychiatric Association said it was pleased the FDA now wanted the black box to note that depression itself may lead to suicide.

Dr. Carolyn Robinowitz, the group's president-elect, said the revised warning was "a major step in the right direction."

"We believe the new label, which still contains important warning information, reminds physicians and patients that antidepressants save lives," she said.

Researchers who published a study in April in the Journal of the American Medical Association said they found the benefits of antidepressants for children and teens far outweighed the risk of suicidal thoughts and behavior.

Pfizer will add the new warning for young adults to the Zoloft label, company spokeswoman Shreya Prudlo said. She added "there is no established causal link between Zoloft and suicide in adults, young adults or children."

Officials at Lilly, Forest and Wyeth also said the companies would add the new warnings to their products.

Source : http://www.sciam.com