Black box labels on antidepressants warning of a link between the drugs and suicidal thoughts in children and young adults may not have had the intended effect, a study published Oct. 7 in Health Affairs found.
Since 2005, the FDA has required antidepressants to display a warning that the drugs may be linked to suicidal thoughts and behavioral for those under 18. The warning was expanded to adults up to age 24 in 2007.
The study, a review of 11 previous studies on the outcomes of the black box warnings, found they did not lead to an increase in monitoring in suicidal thoughts and were linked to a decline in pediatric mental health.
Here are five findings to note:
- "Antidepressant treatment declined by 20% to 50% in the years after the black box warnings were implemented, according to seven studies included in the review."
- Physician visits for depression and depression diagnoses declined after the FDA warnings were implemented, four studies found.
- Some studies found abrupt increases in suicide deaths and suicide attempts among pediatric patients. No study found a decline in suicide deaths following the warnings.
- Fewer than 5% of patients were monitored for suicidal thoughts in accordance with the FDA's recommended schedule after the warnings were implemented, the review found.
- Stephen Soumerai, ScD, a professor of population medicine at the Harvard Pilgrim Health Care Institute, was the lead author of the study. Dr. Soumerai said the consistent harm and absence of benefits observed in the review are "not a coincidence."
"We recommend that the FDA consider incorporating the black box warnings into the list of routine warnings that pose fewer health risks, or potentially removing the warnings altogether," Dr. Soumerai said in an Oct. 7 news release.
Read the full study here.