FDA seeks antidepressant warning | VailDaily.com
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FDA seeks antidepressant warning

WASHINGTON – Young adults beginning treatment with antidepressants should be warned about an increased risk of suicidal thoughts and behavior, federal health officials said Wednesday.

The Food and Drug Administration proposed labeling changes that would expand a warning now on all antidepressants. The current language applies only to children and adolescents. The expanded warning would apply to adults 18-24 during the first month or two of treatment with the drugs, the FDA said.

The proposed labeling changes also would note that studies have not shown this increased risk in adults older than 24, and that adults 65 and older taking antidepressants have a decreased risk of suicidal thoughts and behavior, it said.

The proposed expanded warnings emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.

“Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks,” said Dr. Steven Galson, the FDA’s drugs chief.

The proposed changes came with the endorsement of FDA expert advisers. Some experts have argued that the changes are overdue while others maintain they could keep drugs from those who need them.

Last month, a comprehensive analysis of antidepressants for children and teenagers found the benefits of treatment trump the small risk of increasing suicidal thoughts and behaviors in some patients. The Journal of the American Medical Association study also found that risk is lower than what the FDA identified in 2004, the year the agency warned the public about the risks of the drugs in children.

The proposed label changes would apply to all antidepressants, including Lexapro (Forest Laboratories Inc.), Paxil (GlaxoSmithKline PLC), Prozac (Eli Lilly and Co.) and Zoloft (Pfizer Inc.). Some of the drugs are available in generic form as well.

Messages left with the companies were not immediately returned.

Food and Drug Administration antidepressant information:

http://www.fda.gov/cder/drug/antidepressants/default.htm


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