Science and Law
12th February 2014

NSAIDs Appear on the FDA’s Radar

As we predicted in November (Will Traditional NSAIDs Be the Next Big Pharmaceutical Litigation?), the FDA has signaled its intention to weigh in on the purported link between non-steroidal anti-inflammatory drugs (NSAIDs) and cardiovascular thrombotic risk, a warning that appears on NSAID class labeling.

NSAIDs Appear on the FDA’s Radar

As we predicted in November (Will Traditional NSAIDs Be the Next Big Pharmaceutical Litigation?), the FDA has signaled its intention to weigh in on the purported link between non-steroidal anti-inflammatory drugs (NSAIDs) and cardiovascular thrombotic risk, a warning that appears on NSAID class labeling. An FDA advisory committee met this week to review current labeling rules, but ultimately recommended the FDA maintain the current labeling, at least for now  (read meeting materials here). The meeting increased the visibility of the issue and raised questions in the media about the relative safety of NSAIDs.

A WSJ article published before the meeting noted, “One outcome of the review could be a cleaner label and major marketing advantages for Aleve [naproxen], compared with some or all of its competitors.” However, the advisory panel decided that the available evidence (read the meta-analysis here) fails to demonstrate that naproxen carries a lower cardiac risk than competitor products.

An article published after the meeting pointed out that the majority of the panelists agreed with Milton Packer, MD, who spoke during the public portion of the meeting. Dr. Packer of the University of Texas Southwestern Medical Center said the trials varied significantly in terms of patient populations and drug doses, yielding results that were too weak to support a label change, according to the article.

The panel intends to revisit the issue after the PRECISION trial, a head-to-head comparison of naproxen with ibuprofen and Celebrex. PRECISION, which is about a year from completion, aims to provide a valuable safety comparison. But some experts are skeptical, contending that the study is biased toward a null result.

While NSAIDs continue to attract attention from the FDA, the media and the public, the potential impact on the legal arena remains unclear. Stay tuned to our blog for continuing coverage of this issue.

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