FDA panel urges “black box” warning for antidepressants

Pediatric prescribing practices and the FDA Black-box warning on antidepressants.

BACKGROUND Since the FDA Black box warning in 2004, there has been a 58% drop in antidepressant use among children and adolescents with depression. Paralleling this decrease is an associated increase in completed suicides in youth. To date, no study has examined, on a clinician level, the changes in practice that have occurred subsequent to the FDA warning. OBJECTIVE To examine changes in ped...

A black-box warning for antidepressants in children?

Challenging the FDA Black Box Warning for High Aspirin Dose With Ticagrelor in Patients With Diabetes

Ticagrelor, a novel reversible antiplatelet agent, has a Food and Drug Administration (FDA) black box warning to avoid maintenance doses of aspirin (ASA) >100 mg/daily. This restriction is based on the hypothesis that ASA doses >100 mg somehow decreased ticagrelor's benefit in the Platelet Inhibition and Patient Outcomes (PLATO) U.S. cohort. However, these data are highly postrandomized, come f...

The revised black box warning for antidepressants sets a public health experiment in motion.

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of [insert established name] or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinic...

The black box warning for droperidol.

To the Editor:—I read with interest the recent article and accompanying editorial regarding the black box warning on the package insert for droperidol. Nuttall et al. indicate that droperidol is a safe, effective, and inexpensive antiemetic and that the black box warning on the package insert is not needed. In addition, they seem to believe that their use of droperidol is prevented by the prese...