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FDA clarifies heart risk from NSAID painkillers

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Late last month, the Food and Drug Administration (FDA) announced that Aleve (naproxen), manufactured by Bayer AG, appears to have less risk of a cardiovascular event than other non-steroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen (Motrin and Advil) and celecoxib (Celebrex), which is a prescription medication manufactured by Pfizer Inc. However, on February 11, the agency reversed its opinion that Aleve was safer than other NSAIDs.

An FDA advisory panel voted 16-9 against the conclusion that Aleve and generic equivalents pose a lower risk of heart attack and stroke than similar NSAIDs. The decision includes over-the-counter medications such as Aleve and Motrin as well as stronger prescription medications such as Celebrex to treat arthritis. All NSAIDs contains a warning on their labels that they can increase the risk of heart attack and other life-threatening cardiovascular events. However, controversy has existed for more than a decade whether one type of NSAID is actually safer than another.

This week, the FDA convened a two-day meeting to review the latest evidence, including a meta-analysis published last year that suggested that Advil has less cardiovascular risk than other NSAIDs. (A meta-analysis is a complication of data from several studies to clarify a point.) However, a majority of panelists asserted that the evidence was not conclusive and did not warrant changing the drug's label. The panelists who voted in favor of Aleve being safer conceded that the evidence is not definitive; however, they also noted that they had a “duty to inform the public.”

The study that suggested that Aleve was safer was conducted by Oxford University researchers who combined the results from more than 700 NSAID studies (approximately 350,000 patients); the study concluded that Aleve had less cardiovascular risk. However, the majority of panelists noted that the results were difficult to interpret. Despite the panel's opinion against relabeling Advil and generic equivalents, the assembly did suggest that the safety language of all NSAIDs should be updated. The current labeling suggests that cardiovascular risks only appear after 10 or more days of continuous use. However, a recent Danish study found that heart attack and stroke can occur within less than a week of treatment. Thus, a majority of the panelists recommended that the FDA should consider revising the label to warn of this short-term risk.

The advisory panel’s recommendations mark the latest review regarding the safety of NSAIDs. The first sign of trouble occurred in 2004, when Merck & Co Inc. removed Vioxx off the market because of links to heart attack and stroke. The medication had been heavily advertised as a new kind of NSAID that was supposed to cause less gastric upset; however, its withdrawal ushered in a new era of drug safety at the FDA. In 2005, the agency added boxed warnings to all prescription NSAIDS, including Celebrex and stronger versions of Aleve and ibuprofen. Celebrex is the only drug that is of the same class as Vioxx, which remains on the market. The prescription NSAIDs are primarily used for long-term chronic pain control for conditions such as arthritis. In addition, the FDA added similar warnings to lower-dose, over-the-counter NSAIDs. The labeling on those drugs warn patients to take the lowest dose possible for as short a period as possible.

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