Study finds differences in black-box warnings

Article

Black-box warnings or safety labels on drugs differed widely across drugs and drug classes, according to a new study published in the Journal of Internal Medicine.

Black-box warnings (BBW) or safety labels on drugs differed widely across drugs and drug classes, according to a new study published in the Journal of Internal Medicine. 

Researchers at the University of Ioannina School of Medicine in Greece collected labeling information on the 20 top-selling classes of drugs in 2008 and found labeling differences in 9 of the 20 classes, representing 15 BBW labels.

Furthermore, the information for 10 of the 15 different BBWs was included in the labels of the same-class drugs as simple warnings or texts, while it was absent entirely in 5 BBWs. The median interval from the time the BBW had appeared in another drug of the same class was 66 months.

“Differences in BBW labeling in same-class drugs are common and shape impressions about the safety of similar drugs. BBW labeling needs to become more systematic,” the researchers wrote. Until large-scale, robust evidence on adverse events becomes routinely available, the current system of BBWs allows for flaws, the researchers added.

Newsletter

Pharmacy practice is always changing. Stay ahead of the curve with the Drug Topics newsletter and get the latest drug information, industry trends, and patient care tips.

Recent Videos
Related Content
© 2025 MJH Life Sciences

All rights reserved.