Vioxx alternative Aleve found to cause heart problems

Vioxx patients who may have heard the news about the warning issued by the FDA and the National Institutes of Health (NIH) today should not panic. If your doctor has switched you to Celebrex (which incidentally is a drug that is being closely watched by the FDA and a decision is imminent on whether to recall Celebrex after it was found that it increased the risk of heart attacks) or any other drug, then you should simply go back to your doctor, particularly if you have been taking naproxen (marketed as Aleve in the United States). (Related article: Problems with all drugs like Vioxx may bolster the case of Vioxx victims in class action lawsuits)

As you know, Aleve is an over-the-counter drug found in the drug cabinet of every home. While it may be much less expensive than Vioxx or any of the other drugs like Vioxx, it is fairly effective for controlling pain. Naproxen was first sold as a prescription drug under the trade name Naprosyn in 1976. FDA approved its use as an over-the-counter drug in 1994.

What NIH and the FDA found in a totally different study that had nothing to do with arthritis was that two drugs that have been used as alternatives since the recall of Vioxx, naproxen (220 mg twice a day and commonly sold as Aleve) and celecoxib (200 mg twice a day, commonly sold as Celebrex), was that there was an apparent increase in cardiovascular and cerebrovascular events among the participants taking naproxen when compared with those on placebo. In simple words, Aleve, like Vioxx may be bad for your heart. (Related article: Treatment options for Vioxx patients)

It is very important to understand that neither drug has been pulled off the market yet and this is merely a warning. As indicated on the Aleve label, the FDA says, you should not take the drug for more than 10 days and in higher dosage than recommended on the label, and if you need to do so, you need to speak to your doctor, even though naproxen is an over-the-counter drug. If you are taking Aleve in place of Vioxx, you should not do so without the recommendation of your doctor.

“This step is being taken as a precautionary measure to ensure the safety of the study’s participants,” said NIH Director, Elias A. Zerhouni, M.D. “The investigators made their decision based on the risk/benefit analysis specific to this trial,” added Dr. Zerhouni.

Investigators and NIH scientists will continue to review this and other NSAIDs studies sponsored by NIH in the light of these findings. It should be pointed that the cancer prevention trials and the ADAPT study are among the first long-term, clinical trials to test these classes of drugs. These studies are examining these compounds for uses very different from the uses for which these medications are currently approved. NIH and FDA will work together to provide the public with information they need to make informed health decisions. (Related article: Vioxx alternative Celebrex faces an uncertain future)

At this time, a decision is still awaited from the FDA on what to do with the other Vioxx alternative, Celebrex.

Recommended article: Bextra and Celebrex may need to be recalled