A U.S. Food and Drug Administration (FDA) panel has voted that there is not enough scientific proof to support claims that naproxen, a painkiller sold as Aleve by Bayer Corp., is safer than other nonsteroidal anti-inflammatory drugs (NSAIDs), including ibuprofen. On Feb. 11 the panel voted 16-9 that there is not enough data to show that naproxen poses lower heart health risks compared with other NSAIDs including ibuprofen. Pfizer Inc., a rival drugmaker, markets ibuprofen as Advil and aspirin. The vote came on the second day of a joint meeting between the agency’s arthritis advisory committee and its drug safety and risk management advisory committee.
The FDA has consistently said that such advisory committee recommendations are not binding, and that it makes the final decisions. Pfizer said in a statement that it agrees with the committee’s position that existing data do not show that naproxen has a lower risk of cardiovascular thrombosis — or blood clots forming in a vessel — than do other NSAIDs. Bayer had not commented at press time on the panel’s vote.
Pfizer is backing a large ongoing study called Precision to evaluate the long-term heart health effects of its arthritis medication Celebrex. The drug maker says the study compares Celebrex to other NSAIDs, such as ibuprofen and naproxen, in treating arthritis pain. Pfizer said the clinical trial was devised in agreement with the FDA.
It should be noted that a whistleblower lawsuit was filed in 2012 against Bayer in a New Jersey state court by a former pharmaceutical executive. Dr. Shirley Chen claimed she was fired after telling a senior manager there was no legitimate data to support certain efficacy claims for the pain reliever Aleve. Dr. Chen said that she was fired after pointing out to company officials in November 2011 that certain advertising claims they were poised to make regarding recommended dosages of Aleve for osteoarthritic patients were unfounded. I am not sure about the status of this suit.
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