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A6O2 | Warnings for serious adverse events in drug labelling: are same-class drugs treated the same?

Abstract text
Background:Adverse events carry major morbidity and are a considerable cause of mortality. Black box warnings (BBWs) are the strongest medication-related safety warnings in a drug’s labeling information and are placed on a drug label to highlight major risks. Absence of a BBW or asynchronous addition of a BBW among same-class drugs could create confusion in prescription patterns or differentially favor drugs in the same category and should, thus, be justified appropriately.

Objectives: We aimed to evaluate systematically the concordance in the BBW labeling between drugs of the same class.

Methods: We tagged the 20 top-selling drugs for 2008 (10 with BBWs and 10 without BBWs on their label) that belonged to different drug classes. Labeling information on all drugs belonging in these 20 classes was captured, and differences were recorded regarding the presence and timing of acquisition of BBWs for same-class drugs.

Results: e assessed 176 different agents, belonging to the 20 evaluated drug classes. Seven of these agents had been withdrawn for safety reasons. The reasons for withdrawal became BBWs in other same-class agents only in two of the 7 cases. BBW-related differences were identified in 9 of the 20 classes corresponding to 15 BBWs that were not present in all drugs of the same class. The information for 10 of the 15 different BBWs were included in the labels of same-class drugs as simple warnings or text, 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.

Conclusions: Differences in BBW labeling in same-class drugs are common and shape perceptions of safety among similar agents. BBW labeling needs to become more systematic and requires clear justification for the differences observed within drug classes.
Panagiotou OA1, Contopoulos-Ioannidis DG2, Papanikolaou PN1, Ntzani EE1, Ioannidis JP3
1 Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece
2 Department of Pediatrics, University of Ioannina School of Medicine, Ioannina, Greece
3 Stanford Prevention Research Center, Stanford University School of Medicine, Stanford, USA
Presenting author and contact person
Presenting author: 
Evangelia Ntzani
Contact person: 
Evangelia Ntzani (Contact this person)
Date and Location
Oral session A6O2
Friday 21 October 2011 - 11:35 - 12:05