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Drugs for depressed get new warnings

By ASSOCIATED PRESS
Published December 14, 2006

WASHINGTON - Antidepressants increase the risk of suicidal behavior for people up to age 24, the government said Wednesday. It plans new warning labels and says users of all ages should be closely monitored.

The label change proposed Wednesday would expand a warning now on the antidepressants that applies only to children and adolescents.

The Food and Drug Administration put forth its plan to update the drug labels at a meeting of outside advisers on the issue. They endorsed the plan.

The FDA also stressed that patients of all ages should continue to be carefully monitored for signs of suicidal tendencies when they are beginning treatment on the drugs.

Public reaction was split, with some saying the changes were overdue and others arguing they could keep drugs from those who need them.

Psychiatrists testified Wednesday that the 2004 addition of a warning for children led to a falloff in antidepressant prescriptions being written for patients under 18 - and an increase in suicides in that age group.

Still, overall use of antidepressants continues to grow, with nearly 190-million prescriptions dispensed in the United States last year, according to IMS Health, a health care information company. That suggests doctors have placed more weight on the long-term benefits of the drugs than on any short-term risks, said Dr. Thomas Laughren, director of the FDA's division of psychiatry products.

Expanding the "black box" or other warnings on the drugs could dissuade patients from seeking or starting treatment, mental health experts said. They warned that people with untreated depression - about half of those who suffer from the disease - face an estimated 15 percent greater likelihood of death by suicide.

Dr. Joseph Glenmullen, a Harvard Medical School clinical instructor in psychiatry and author of Prozac Backlash, said expanding the warnings wouldn't scare off patients, but instead would allow them to make informed choices.

The FDA recently completed a review of 372 studies involving about 100,000 patients and 11 antidepressants, including Lexapro, Zoloft, Prozac and Paxil.

When the results were analyzed by age, it became clear there was an elevated though small and short-term risk for suicidal thoughts and behavior among adults 18 to 24, the FDA said in documents released ahead of Wednesday's meeting of its psychopharmacologic drugs advisory committee.

The FDA's analysis of the multiple studies suggests an age-related shift in the risk of suicidal thoughts and behavior associated with treatment with the drugs. For instance, antidepressants seem to protect against suicidal thoughts and behavior in adults 30 and older, with the effect most pronounced in patients over 65.

The FDA said the increased risk could mean as many as 14 additional cases of suicidal thoughts or behavior in every 1,000 children treated with antidepressants. For adults 18 to 24, there could be four additional such cases per 1,000.

[Last modified December 14, 2006, 00:53:19]