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ANTIDEPRESSANT LABELING EXPANDED AGAIN

Published Online: Friday, June 1, 2007   [ Request Print ]

<p>It looks as if antidepressant drug labels are headed for revisions. The FDA wants drugmakers of all antidepression medications to update the existing black-box warning on their products&rsquo; labeling. The agency is proposing that the labels include warnings about the increased risk of suicidal thinking and behavior, known as suicidality, in young adults aged 18 to 24 during the first 1 to 2 months of treatment.</p>
<p>Furthermore, the FDA&rsquo;s proposed labeling changes include language stating that scientific data did not find this increased risk in adults older than 24, and that adults aged 65 and older taking these medications have a lower risk of suicidality. The suggested warning statements also underscore that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide.</p>
<p>The manufacturers of antidepressant drugs were given 30 days to submit their revised product labels and revised Medication Guides to the agency for review. The latest proposed labeling expansion follows similar labeling changes made 2 years ago that warned of a suicidality risk in children and adolescents who use these medications.</p>
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