Antidepressant labeling updated yet again
The FDA is requesting an update to the existing black box to include information regarding the risk of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first two months of treatment.
The FDA has proposed new labeling changes to manufacturers of antidepressants. This time, the agency is requesting an update to the existing black box to include information regarding the risk of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first two months of treatment. In addition, manufacturers are asked to include a statement explaining that scientific data did not show this increased risk in adults older than 24 years and that patients over 65 years old actually have a decreased risk of suicidal thinking when taking antidepressants. Companies have 30 days to submit their updated product labeling and Medication Guides to the FDA for review. Labeling changes made in 2005 required the addition of a black box warning and Medication Guides to describe an increased risk of suicidal thinking and behavior in children and adolescents. The new agency request applies to the entire category of antidepressants.
To see more Hot off the Press news articles, click here.
To go to the Drug Topics homepage, click here.
Pharmacists Play Unique Role in Advancing Health Equity for Patients With Chronic Disease
December 7th 2023A new study, outlined in a poster at ASHP Midyear 2023, identified 3 key themes associated with the ways in which pharmacists are positioned to advance health equity for patients with chronic diseases.
