Differences in safety warning labels identified in nine of 20 top-selling drug classes
MONDAY, Feb. 14 (HealthDay News) -- Labeling differences of black box warnings (BBWs) in drugs of the same class are common and affect perceptions of safety of similar agents, according to a study published online Feb. 1 in the Journal of General Internal Medicine.
Orestis A. Panagiotou, M.D., from the University of Ioannina School of Medicine in Greece, and colleagues collected labeling information on the 20 top-selling drug classes in 2008 and recorded the differences in the presence and timing of acquisition of BBWs for drugs from the same class.
The researchers identified 176 different agents in the 20 drug classes. Seven of these agents were withdrawn due to safety considerations. In two of these cases, the reason for withdrawal became a BBW in other same-class agents. Labeling differences were identified in nine of the 20 classes, representing 15 BBWs that were not present in all same-class drugs. The information pertaining to 10 of these 15 BBWs was present in the labels of same-class drugs as warnings or text, but were completely absent in five BBWs. The average time for the BBW to appear in another drug of the same class was 66 months.
"Until large-scale robust evidence on adverse events becomes routinely available, the current creation and application of BBWs allows introduction of flaws," the authors write. "Overall, our findings imply that the process of BBW acquisition requires transparent and systematic rules and clear justification for the presence or lack of evidence for specific major risks for specific drugs."
Full Text (subscription or payment may be required)