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Merck & Co. has taken its arthritis medication Vioxx® (rofecoxib) off the market due to concerns that it may significantly increase the risk of heart attack and stroke.
The company based the withdrawal on the results of a now halted study that sought to determine whether Vioxx would prevent the recurrence of colorectal polyps in patients with a history of colorectal adenomas.
The study found that the increased relative risk for heart attack and stroke began after patients had been treated for 18 months with Vioxx, a COX-2 inhibitor drug, compared to those taking placebo.
However, Merck noted that study results for the first 18 months of the study did not show any increased risk of these cardiovascular events with Vioxx. The company said these shorter-term results are similar to the results of two placebo-controlled studies described in the current U.S. labeling for the drug.
Merck has informed the U.S. Food and Drug Administration and regulatory authorities in other countries of its decision. The company also is in the process of notifying health care practitioners in the United States and other countries where Vioxx is marketed.
Merck officials said patients currently taking Vioxx should contact their health care providers to discuss discontinuing use of the drug and possible alternative treatments. An estimated 105 million Vioxx prescriptions were written in the United States from May 1999 to August 2004. About 20 million patients in the United States are believed to have taken the drug.
Source:
Medical Week Staff, week
of September 25, 2004
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