- The Washington Times - Wednesday, December 13, 2006


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

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

The Food and Drug Administration (FDA) put forth its plan to update the drug labels at a meeting of outside advisers on the issue. The changes also would include a recommendation for careful monitoring, especially when patients are beginning treatment.

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

In emotional testimony illustrated at times by slides of family photos, relatives of suicide victims pleaded for the warnings.

Suzanne Gonzalez, shouting and in tears, goaded the panel to action. She said her 40-year-old husband who had been taking Paxil shot himself.

“I wake up every morning thinking, ‘Oh my God, he’s dead.’ Do you wake up and think, ‘How many people are going to die today because I am doing nothing?’ ” Mrs. Gonzalez asked.

Still, mental health specialists worry that additional warnings could curtail use of the drugs and ultimately do more harm than good.

Dr. John Mann, a Columbia University psychiatrist, suggested simply replacing the proposed expanded warnings with the recommendation that doctors monitor their patients more closely.

“We can do more good by providing more treatment for depressed children and adults,” Dr. Mann said.

The FDA proposed the changes after completing a review that found use of the drugs might increase the risk of suicidal thoughts and behavior among adults 18 to 24, as well as among younger patients.

Psychiatrists testified yesterday that the 2004 addition of a warning for children led to a falloff in antidepressant prescriptions being written for patients younger than 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.

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 yesterday’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 older than 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.

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