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Naproxen Side Effects

On December 20, 2004, the National Institutes of Health (NIH) announced research investigators were suspending the use of two drugs naproxen and Celebrex from its large, three-arm, national Alzheimers disease prevention trial. Just days after Pfizer Inc. said its best-selling arthritis drug Celebrex was associated to increased heart risks, the naproxen side effects announcement was made.

As a precautionary measure, the study investigators made their decision based on the risk/benefit analysis that was specific to the trial. Up until the recent naproxen side effects announcement, researchers claim there has been no evidence that the use of naproxen could cause heart problems. The concerns were prompted by preliminary findings by the NIH study that showed patients taking naproxen have about a 50 percent greater chance of suffering strokes or heart attacks than those taking a placebo.

According to the studys principal investigator, Dr. John Breitner, there was a fairly impressive signal of increased risk of heart attack and stroke for naproxen side effects in the study. While more research will need to be performed to better understand the actual naproxen side effects risks, Breitner thinks it will be hard to find anyone to take part in placebo-controlled trials with NSAIDs.

NSAIDs, or nonsteroidal anti-inflammatory drugs, are a class of drugs that includes over-the-counter drug naproxen, as well as prescription drugs Vioxx, Celebrex and Bextra. Vioxx, Celebrex and Bextra belong to a subset of NSAID drugs, called COX-2 inhibitors. At the end of September 2004, Vioxx was recalled from the market in the largest prescription drug recall because of significant increased risks of heart attack and strokes. Just after the Vioxx recall, studies indicated both Bextra and Celebrex also showed links to increased heart risks, and Bextra labeling was changed in response and Celebrex warnings issued.

The discovery of possible naproxen side effects calls into question if the adverse effects could be a class wide effect. Preliminary naproxen side effects have left federal officials, researchers, doctors and patients confused about the entire situation. Breitner said he has no knowledge of whether this is unique to naproxen, or whether it may be a problem for all NSAIDs, saying that, weve never had the opportunity to study that.

Although the FDA issued Celebrex warnings a few days prior, urging patients to seek alternative drug treatments, drug officials stopped short of doing the same in light of the possible naproxen side effects. Consumers have been urged to avoid possible increased risk of naproxen side effects by following label directions carefully and avoiding taking the drug for more than 10 days.

When the naproxen side effects announcement was made, it was after the stock markets had closed. Bayer manufacturers name-brand naproxen under the name of Aleve, and the company said at the time of the announcement it had not yet seen the data to comment on the study. FDA drug researcher and whistleblower David Graham told CNNs American Morning that, over-the-counter drugs are supposed to be the ones that are absolutely the safest. Dr. Sandra Kweder, deputy directory of the FDAs Office of New Drugs says, This is a very confusing situation.

For more information on naproxen and aleve side effects, please contact us to confer with a Naproxen Lawyer and learn your legal rights and options.

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