Different Black Box Warning Labeling for Same-Class Drugs

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...

A black-box warning for antidepressants in children?

Black Box Warnings in Prescription Drug Labeling:

Prescription drugs are unavoidably associated with adverse effects, but the benefits of using such drugs outweigh the accompanying risks so long as the expert judgment of a licensed practitioner is first applied in the decision to use a drug for a particular patient. Most risks for prescription drugs appear in descending order of importance in the drug’s labeling, i.e., the package insert. The ...

Black box warning: is ketorolac safe for use after cardiac surgery?

OBJECTIVE In 2005, after the identification of cardiovascular safety concerns with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), the FDA issued a black box warning recommending against the use of NSAIDs following cardiac surgery. The goal of this study was to assess the postoperative safety of ketorolac, an intravenously administered NSAID, after cardiac surgery. DESIGN Retrospect...

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...