Vioxx found to increase risk of heart attack

According to Merck, the maker of Vioxx, its decision to withdraw Vioxx from the market was based on data from a "prospective, randomized, placebo-controlled clinical trial, known as the "APPROVe" trial. The trial, which was also terminated, was established to test the efficacy of Vioxx in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas. Some 2,600 patients were enrolled in the study which commenced in 2000. According to Merck, the clinical trial revealed that beginning after 18 months, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, among the test group taking Vioxx as compared to those taking placebo. According to Merck, the results for the first 18 months of the study, which supported two earlier placebo-controlled studies described in the current U.S. labeling for Vioxx, did not indicate any increased risk of heart attacks or other cardiovascular events for those taking Vioxx.

Researchers have been quick to point out that the results of a study or clinical trial with one molecule in a given class of drugs (Vioxx) are not necessarily applicable to other drugs in the class (eg. Celebrex, Bextra). Accordingly, the clinical significance of the APPROVe trial (if any at all), for the long-term use of other COX-2 specific inhibitors and NSAID's, is not known.

While the FDA did not force Merck to withdraw Vioxx from the market, it did agree with the company's decision to pull the drug and stated, "there appear to be significant safety concerns for patients, particularly those taking the drug chronically."

Both Merck and the FDA recommend that patients who are currently taking Vioxx should contact their physician for recommendations regarding the discontinuation of Vioxx and potential alternative therapies. Further, they indicated that patients and health care professionals could obtain information from www.merck.com and www.vioxx.com, or by calling 1-888-36-VIOXX (1-888-368-4699).