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IND -- Merck pulls Vioxx from market

Sunday, January 02 2005 | Comments

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What's This? Merck & Co. Inc. voluntarily pulled its arthritis drug Vioxx (rofecoxib) from the market because of heart safety concerns. Merck said its decision to pull Vioxx is based on new, three-year data from a clinical trial known as the APPROVe (Adenomatous Polyp Prevention on VIOXX) trial. The trial, which is being terminated, was designed to evaluate the efficacy of Vioxx in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas. During the study, however, investigators found an "increased relative risk for confirmed cardiovascular events," such as heart attack and stroke, beginning after 18 months of treatment in patients taking Vioxx as compared with those taking placebo. Merck noted that the results for the first 18 months of the study did not show any increased risk of confirmed cardiovascular events in patients on Vioxx, and in this respect, are similar to the results of two placebo-controlled studies described in the current U.S. labeling for Vioxx. "We are taking this action because we believe it best serves the interests of patients," said Raymond Gilmartin, chief executive officer of Merck. "Although we believe it would have been possible to continue to market Vioxx with labeling that would incorporate these new data, given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take." Merck said it is in the process of notifying health care practitioners in the United States and other countries where Vioxx is marketed. The Food and Drug Administration also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications. "Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," said acting FDA Commissioner Dr. Lester M. Crawford. "Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo." Dr. Crawford noted that the FDA will closely monitor other drugs in this class for similar side effects. The FDA approved Vioxx in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. Subsequently, the FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children. According to data from Pharmaprojects, a database tracking pharmaceutical research and development, Pfizer Inc. is currently in a position to benefit the most from Merck's withdrawal of Vioxx. In a press release, Pharmaprojects suggested that Merck will likely attempt to shift Vioxx users to Arcoxia (etoricoxib), its other COX-2 inhibitor, but added, "Pfizer has the remaining three [COX-2 inhibitors] on the market, so is likely to seek to benefit from Merck's discomfort." Pharmaprojects also noted that Pfizer may benefit from the opening left by Vioxx in the treatment of migraine; the company is currently awaiting approval of its drug valdecoxib for this indication.

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