More than 84 million people worldwide face a reduced incidence of heart attack, stomach bleeding, or stroke now that VIOXX, the popular arthritis medication, has been pulled from the market.
Echoing one of its commercial jingles, Thursday September 30, 2004 turned out to be not such a beautiful morning for Merck, the New Jersey-based international pharmaceutical company that has been manufacturing VIOXX since 1999. Merck chairman, president, and chief executive officer, Raymond V. Gilmartin, said of the recall, “We are taking this action because we believe it best serves the interests of patients.”
|More Information About Vioxx Recall
1) For those taking VIOXX, please contact your physician for alternative medications (scroll down page to box at bottom)
2) Click here for more information from the U.S. Food and Drug Administration: Vioxx FAQs
3) For further information, you may call VIOXX at 1-888-36-VIOXX
4) Merck's withdrawal of VIOXX stemmed from the results of a clinical trial where it was determined that patients who took the drug for longer than 18 months showed an increased risk of cardiovascular events, such as heart attacks and strokes
5) For information on how to get a refund for Vioxx, click here: Vioxx refund
Generically known as rolecoxib, VIOXX was used primarily to relieve symptoms of arthritis and acute pain by helping patients regain flexibility.
Questions about the safety of VIOXX are not new. In 2000, Merck’s VIGOR study indicated that there was an increased risk of cardiovascular problems while using the drug. In 2002, Merck added new safety information to VIOXX labeling after the FDA issued a warning to the company for downplaying the cardiovascular risks associated with the drug’s use. In August 2004, an FDA-sponsored study also revealed that patients who took the starting dose of VIOXX were 50 percent more likely to suffer heart attacks and sudden cardiac death than patients who took Celebrex, the arthritis treatment manufactured by Pfizer. The same study found that patients taking the highest recommended dose of VIOXX, 50 milligrams, were three times more likely to face the lethal health risks.
It was little surprise then when the results of a new study hinted at a murky future for VIOXX. The APPROVe trial was designed to assess how effective the standard 25-milligram dose of VIOXX was in preventing the recurrence of sometimes-cancerous colon polyps. VIOXX was used in this trial because another study suggested that small, daily doses of aspirin could prevent colon cancer. From 2000 to 2003, APPROVe compared the effects of VIOXX versus placebo among 2,600 patients. The APPROVe study was multi-centered, randomized, and double-blind—investigating patients from different geographic areas; canceling the influence of factors not under study; and allowing the most objective results to surface because neither patient nor practitioner knew whether the drug was placebo or not.
After the first 18 months, Merck said they noticed that APPROVe began to produce disapproving results. Patients who were using VIOXX experienced twice as many heart attacks and strokes as the placebo group. In all, the increased relative risk caused 15 cases of heart attack, stroke, or blood clots per 1,000 among the VIOXX-using trial subjects. Before the 18-month mark, the APPROVe study did not show that VIOXX increased the risk of confirmed cardiovascular events because the results, up to this time, were similar to the results from those who used the dummy pills.
|Alternatives to VIOXX
Other NSAIDS (non-steroidal anti-inflammatory drugs) as prescribed by a physician
Advil, Aleve, Tylenol for less severe cases of arthritis
An independent panel, studying the APPROVe results, concluded a few days before Sept. 30 that taking VIOXX for more than 18 months doubled the risk of heart attack or stroke. The results left Merck with two options: edit the product’s warning labels again or recall VIOXX—the option they voluntarily pursued worldwide.
Researchers still do not understand why there is an increased risk of heart attacks and strokes associated with VIOXX, but one can expect Merck to evaluate this and other drugs further. Said Dr. Peter S. Kim, president of Merck Research Laboratories, “Merck has always believed that prospective, randomized, controlled clinical trials are the best way to evaluate the safety of medicines.”
The lack of VIOXX on the market would not prove entirely drastic for most patients. “There are very few patients for whom there won't be a good alternative drug,” said Dr. Steven Abramson, director of rheumatology at New York University Hospital for Joint Diseases. Furthermore, other doctors advise that younger patients who are otherwise healthy, and patients who have been using the drug for less than 18 months, do not need to immediately stop using the drug. However, older patients, especially those with a history of heart disease, should cease using the drug immediately. Patients should speak with their health care providers to discuss possible alternative treatments. They may also call 1-888-36-VIOXX for more information. Merck has even promised to reimburse customers for unused medication.