WASHINGTON – Young adults beginning treatment with antidepressants should be warned about an increased risk of suicidal thoughts and behavior, federal health officials said Wednesday.\nThe Food and Drug Administration proposed labeling changes that would expand a warning now on all antidepressants including Prozac, made by Indianapolis’ Eli Lilly and Co. 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.\nThe 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.\nThe proposed expanded warnings emphasize that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.\n“Antidepressant medications benefit many patients, but it is important that doctors and patients are aware of the risks,” said Dr. Steven Galson, director of FDA’s Center for Drug Evaluation and Research.\nThe 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.\nLast month, a comprehensive analysis of antidepressants for children and teenagers found that 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.\nThe 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.\nMessages left with the companies were not immediately returned.\n___
On the Net:\nFood and Drug Administration antidepressant information:\nhttp://www.fda.gov/cder/drug/antidepressants/default.htm
