FDA advisory panel ambivalent on NSAID cardiovascular risk

The US Food and Drug Administration’s joint Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee was split on whether the data show adequate differences in cardiovascular risk among non-steroidal anti-inflammatory drugs (NSAIDs) to support labeling change for NSAIDs due to cardiovascular (CV) risk.

The advisory panel was convened after a retrospective analysis from multiple clinical trials published last year in The Lancet suggested naproxen was less dangerous to the heart than other NSAIDs, such as ibuprofen and Celebrex. Among naproxen products, Naprosyn is a prescription product sold by Switzerland’s Roche, while Aleve is sold over the counter by Germany’s Bayer. Ibuprofen is marketed as Advil by Pfizer and Motrin by Johnson & Johnson. Celebrex is a prescription product made by Pfizer.

The committee found that there was not enough data at this time to differentiate among the NSAIDs. During the discussion, the committee did recognize the risk of gastrointestinal (GI) events when taking NSAIDs. The panel voted 16-9 that, while the retrospective combining of results from different studies, or meta-analysis, hints at a relative benefit for naproxen over other NSAIDs, the data is not reliable and does not warrant changing the prescribing information to reflect a differentiated risk. The FDA will take the committee's discussion into consideration and will make the final determination in this matter.