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Drugs warning -- check the label
Date:2/2/2011

rugs' labels. Significantly, withdrawn drugs tended not to have a black box warning before their withdrawal and the reason for their withdrawal rarely became a black box warning for the other drugs in the same category.

In addition, among the 10 drug classes with at least one warning, there was a considerable time-lag in black box warning acquisition in 8 categories, ranging from 2 months to 14 years in some cases.

The authors argue that labels should mention and justify why a major recognized risk is not an issue for a particular agent in the same class, where other members have demonstrated major toxicity. In their view, unjustified omission of a black box warning may leave patients largely unaware of potential risks.

Orestis Panagiotou and colleagues conclude: " Our findings imply that the process of black box warning acquisition requires transparent and systematic rules, as well as clear justification for the presence of, or lack of evidence for, specific major risks for individual drugs."


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Contact: Renate Bayaz
renate.bayaz@springer.com
49-622-148-78531
Springer
Source:Eurekalert  

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