FDA rejects Merck's Vioxx-type drug

On April 12, 2007 the Food and Drug Administration (FDA) review committee voted 20-1 to reject Merck’s application for a new Vioxx-type pain relieving drug. Some scientists on the review panel openly criticized Merck for poorly designed research studies, and for blatantly trying to show its new drug, called Arcoxia, in the best light rather than gather scientifically-relevant data.

Sound familiar? Merck has been accused manipulating data and eliminating unexpected (and unwanted) results from clinical trials in order to get FDA approval for Vioxx. The difference is that it didn’t work this time.

Arcoxia is part of the nonsteroidal anti-inflammatory drugs (NSAIDs) class of drugs, which includes Merck’s own Vioxx as well as Celebrex and Bextra, both manufactured by Pfizer. All four drugs are also called COX-2 inhibitors, relieving pain by reducing the amount of a certain chemical in the body.

These so-called “next generation” pain relievers were touted as superior because they offered the same pain relief as aspirin and ibuprofen, but did not have the same gastro-intestinal side effects. As many as 25% of people who needed to take pain relievers suffered stomach side effects from “traditional” alternatives, and 5% suffered from serious effects like stomach bleeding, kidney failure, and even death. Obviously drugs like Vioxx and Arcoxia, which supposedly reduced these risks, would be a welcome alternative for these people.

The problem was, the COX-2 inhibitor side effects were in many cases worse than the alternative – and Vioxx was the worst of the group. Not only did doctors and patients find that stomach side effects were still possible with these NSAIDs, but over time scientists began to realize that the risk of heart attack and stroke was increasing. By some estimates, Vioxx alone has caused 60,000 heart attack deaths in the United States.

Arcoxia, dubbed the “son of Vioxx” by Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, does not appear to be much safer. "If it's approved, I believe people will be hurt,” he told USAToday.

In fact, Dr. David Graham (the ex-FDA scientist who became the Vioxx whistleblower) said that he estimated for every one million patients taking Arcoxia, the number of heart attacks would increase by up to 30,000 every year.

Merck has stated that it is disappointed by the decision, but is “committed to continuing to work with the FDA to discuss the application in an effort to gain U.S. regulatory approval for Arcoxia." Arcoxia is available in Europe and dozens of other countries around the world.

If you have been injured while taking Vioxx or any other drug, you may be eligible for compensation. Contact a Vioxx lawyer with Jim S. Adler & Associates for a free case review, and find out if we can help you recover your medical costs and lost wages, and compensate you for your mental anguish. Call us directly, or fill in the form on this page with the details of your Vioxx case, and someone from Jim S. Adler & Associates will contact you with a free case assessment.