FDA’s NSAID Panel Nixes Naproxen Safety Claim
SOURCE: MedPage Today ~ 2-11-2014
By John Gever, Deputy Managing Editor, MedPage Today
In 16-9 vote, the FDA advisory committee assessing NSAID safety said the warning label on naproxen should not be changed to suggest it has a better cardiovascular risk profile than other drugs in this class.
Those voting “No” on the question indicated that the current evidence on naproxen’s safety — much of which was indirect, coming from studies in which it served as a comparator to a coxib drug — did not meet the standards necessary to support label statements.
The panel — comprising members of FDA’s arthritis and risk management committees — split more closely on a question about label information on the duration of NSAID treatment that raises cardiovascular safety risks.
Currently, labels for these drugs say that short-term treatment is relatively safe; however, some recent studies have sown doubt. A total of 14 panel members said the current statement should be reconsidered, while 11 voted No.However, most of those in the latter camp indicated in post-vote discussion that they believed there is no completely safe dosing period.
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