Vioxx drug recall; pain and arthritis drug shown to increase risks of stroke, heart attack
Thursday, September 30th, 2004.
Results of a recent study on Vioxx confirmed long-standing concerns that the drug increases the risk of stroke and heart attack, spurring maker Merck to voluntarily pull the drug worldwide (in some countries, the drug is marketed under the name “Ceoxx”).
Vioxx is regularly prescribed for treatment of arthritis and acute pain in adults including the pain associated with menstrual cycles. It was recently approved for use in children suffering from rheumatoid arthritis.
The increased risks began surfacing 18 months into a three year study designed to analyze Vioxx’s effectiveness in preventing the recurrence of colorectal polyps. Such polyps sometimes become cancerous. Patients in the clinical study taking Vioxx were twice as likely to suffer from stroke or heart attack as those taking placebo. The study was halted as a result of the findings.
Vioxx was FDA approved in May 1999. A June 2000 study—VIGOR (VIOXX GI Outcomes Research)—first indicated the connection between Vioxx and heart attacks, raising health concerns about chronic use of the drug. As late as September of 2001, the FDA sent a warning letter to Merck accusing it of glossing over these findings in their advertising and other literature. The FDA’s letter mentions, among other things, a press release issued in May of 2001:
We have identified a Merck press release entitled, “Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx,” dated May 22, 2001, that is also false or misleading for similar reasons stated above. Additionally, your claim in the press release that Vioxx has a “favorable cardiovascular safety profile,” is simply incomprehensible, given the rate of MI [myocardial infarctions] and serious cardiovascular events compared to naproxen. The implication that Vioxx’s cardiovascular profile is superior to other NSAIDS is misleading; in fact, serious cardiovascular events were twice as frequent in the VIOXX treatment group (101 events, 2.5%) as in the naproxen treatment group (46 events, 1.lYo) in the VIGOR study.
According to CNN.com, about 2 million people worldwide are on Vioxx (rofecoxib), which is the 16th most used drug in the U.S. Although, CNN.com also reported that “Vioxx sales have been flat in recent years amid safety concerns.” Doctors instead turned to Celebrex and Bextra, neither of which have been linked to heart attack and stroke. Nonetheless, Vioxx was a major revenue source for Merck, with worldwide sales totaling some $2.55 billion last year.
If you are currently taking Vioxx, the FDA and Merck urge you to contact your physician to investigate alternative treatments. Pharmacists will not fill any outstanding prescriptions for the drug.
Vioxx Press Releases
- FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product
- Questions & Answers about Vioxx (FDA’s site)
- Merck Announces Voluntary Worldwide Withdrawal of VIOXX®
From CNN.com
- Doctor tells panel Vioxx raises heart attack risk. Thursday, February 17, 2005 Posted: 10:46 AM EST (1546 GMT)
- Report: Merck knew Vioxx unsafe in 2000. Monday, November 15, 2004 Posted: 10:16 AM EST (1516 GMT)
- Arthritis drug Vioxx being pulled. Thursday, September 30, 2004 Posted: 9:59 AM EDT (1359 GMT).
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