The Food and Drug Administration (FDA) has long warned antidepressants have been linked to suicidal thoughts and behaviors among the youth. To raise awareness, “black box” warnings have been put on these medications since 2005.
Black box warnings, labels in bold black border on the medication or in the info pamphlet, highlight the medication’s risks.
However, new research from the Harvard Pilgrim Health Care Institute has found these warnings might have the opposite effect for pediatric health care and suicidality.
The review found a link between black box warnings and decreased mental health care and increases in psychotropic drug overdoses and suicide deaths.
Psychotropic drugs affect how the brain functions and cause changes in mood, awareness, thoughts, feelings or behavior.
The study found even after putting black box warnings in place, doctors only monitored about 5% of pediatric patients as the FDA had recommended, which is about the same rate it was before the labels were added. Researchers said the warnings seemed to make doctors think again before prescribing antidepressants to kids and teens — with up to 50% declines in use after they were implemented. They say the same changes could be seen among young adults 18 to 24 years old.
The study’s authors said based on their findings, they recommend that instead of displaying prominent black box warnings, the FDA incorporate the concerns into the regular warnings list or even get rid of them altogether.
Depression is a leading cause of suicide in the U.S. and suicide is the second-leading cause of death among 10- to 14-year-olds and the third-leading cause of death among 15- to 24-year-olds, according to the National Institute of Mental Health.
While researchers said they recognized the link between black box warnings and youth suicide rates, that does not necessarily mean the warnings are what caused the change.
Help is available for those struggling with thoughts of suicide or self-harm. You can call or text the National Suicide and Crisis Lifeline at 988 for free, confidential support 24/7.