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Antidepressants may get new labels Legal Evaluation

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Antidepressants May Get New Labels

December 2006

The Food and Drug Administration (FDA) will decide if antidepressant labels should include a warning for patients that the drugs can increase suicidal thoughts and behavior in patients up to age 24. Currently, antidepressants carry a “black box” warning label for children and adolescents.

The FDA decided the labels may need to change after studies reported adults up to age 24 using antidepressants were more than twice as likely to have suicidal thoughts and behaviors as those taking sugar pills. The studies didn’t suggest that antidepressants increased suicide risk for adults ages 25 to 64, but found the drugs reduced the risk in patients 65 and older.

The FDA is also recommending monitoring all patients of every age after beginning an antidepressant regimen. Mental health advocates worry that the proposed warnings could do more harm than good by decreasing the use in people who should be taking the antidepressants.

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Source: “Feds Propose Anti-Depressant Label Changes.” The Associated Press. December 13, 2006.

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