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Carol Eustice

FDA Advisory Committee Votes Down Naproxen Label Change

By February 11, 2014

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pillsOn February 10-11, 2014, there was a Joint Meeting of the Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee. Up for consideration was a change to the warning label on naproxen that would reflect the drug has a better cardiovascular risk profile than other drugs in the NSAID (nonsteroidal anti-inflammatory drug) class. According to MedPage Today, in a 16-9 vote, the FDA advisory committee decided the warning label should not be changed due to the fact that safety data came indirectly via studies that compared naproxen to a COX-2 inhibitor.

Another matter that was considered by the committee pertained to current label information which suggests a short course of NSAIDs is relatively safe. Fourteen committee members said that should be reconsidered, while 11 voted against reconsidering the label statement.

Both of these matters were brought before the committee to determine if labeling needed to be updated based on more current studies compared to what was presented in the early 2000s and ended with a boxed warning about cardiovascular and gastrointestinal risks in 2005. In 2013, The Lancet reported that while all NSAIDs carry some cardiovascular risk, naproxen appeared safest. The FDA advisory committee decided now that has yet to be proven.

Naproxen - What You Need to Know | Facts About NSAIDs | NSAID Quiz

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