FDA Panel Says Available Data Does Not Prove Naproxen Has Lower Heart Risk Than Rival Products
Pfizer’s naproxen does not carry a lower cardiac risk than rival products, an advisory panel citing available evidence told the U.S. Food and Drug Administration (FDA) this week. Naproxen is sold under brand names Aleve and Naprosyn.
The FDA Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee convened after analyzing multiple clinical trials published in The Lancet last year. Data showed naproxen was not significantly safer to the heart compared to other non-steroidal anti-inflammatory drugs (NSAID) like Celebrex and ibuprofen.
The pharma company said it agrees with the panel’s recommendation. “Pfizer agrees with the recommendation…that the available data do not support a conclusion that naproxen has a lower risk of cardiovascular thrombotic events as compared to other non-steroidal anti-inflammatory drugs (NSAIDs). Based on Pfizer’s review of the data discussed, we believe there is insufficient evidence to make this type of distinction. Differentiation between NSAIDs on cardiovascular safety should be based on substantial scientific evidence.”
The advisory panel recommended the current product labeling be left as it is by the FDA until results from a large, ongoing study sponsored by Pfizer, known as Precision, become available.
“Pfizer is sponsoring a study that may provide substantial evidence. Precision is a large, ongoing, well-controlled, randomized clinical trial designed in agreement with FDA to assess the relative long-term cardiovascular safety of Celebrex compared to prescription doses of two commonly prescribed NSAIDs, ibuprofen and naproxen, in the treatment of arthritis pain. It is an important study that will provide meaningful information on the cardiovascular safety of these medicines,” the company said in its press release.
The FDA is not required to follow the recommendations of its advisory panel, but usually takes its advice in consideration. The FDA’s final decision could have significant implications in guidelines for drug prescription and use in the future, as well as for whether Pfizer’s Precision trial will continue.
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