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WASHINGTON -- The U.S. Food and Drug Administration (FDA) proposed Tuesday that all makers of antidepressant medication should update their existing black box warning on product labeling with information about increased risks of suicidal thinking and behavior in young adults.
During initial treatment (generally the first one to two months), young adults aged 18 to 24 on antidepressant medication face a substantial increased risk of experiencing suicidal tendencies, the federal health regulator warned.
The proposed labeling changes apply to the entire category of antidepressants. Manufacturers of antidepressants will now have 30days to submit their revised product labels to the FDA for review.
However, the proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults aged 65 and older taking antidepressants have a decreased risk of experiencing suicidal tendencies.
During initial treatment (generally the first one to two months), young adults aged 18 to 24 on antidepressant medication face a substantial increased risk of experiencing suicidal tendencies, the federal health regulator warned.
The proposed labeling changes apply to the entire category of antidepressants. Manufacturers of antidepressants will now have 30days to submit their revised product labels to the FDA for review.
However, the proposed labeling changes also include language stating that scientific data did not show this increased risk in adults older than 24, and that adults aged 65 and older taking antidepressants have a decreased risk of experiencing suicidal tendencies.
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