Vioxx Safety Timeline

In November 1998, Merck sought approval from the US Food and Drug Administration (FDA) for Vioxx (generic name, rofecoxib), after having tested the drug on 5400 people in eight studies. In May 1999, the FDA approved Vioxx for the treatment of osteoarthritis, menstrual pain and the management of acute pain in adults. Merck voluntarily withdrew Vioxx from the market in September 2004. This article highlights some of the key dates of studies, articles and other events regarding the safety of Vioxx. If you have questions about Vioxx, contact your doctor or an attorney who has handled Vioxx litigation.

VIGOR Study

In November 2000, the Vioxx Gastrointestinal Outcomes Research (VIGOR) study was published in the New England Journal of Medicine. Merck began the study in January 1999 to obtain data to support a gastrointestinal safety claim. VIGOR compared approximately 4000 patients on 50 mg of Vioxx per day (twice the highest approved dose) to approximately 4000 patients on the standard dose of Naprosyn (naproxen), an older NSAID. VIGOR was a one-year, double-blind study, meaning that neither the patients nor the researchers knew who was receiving which drug. According to study results, Vioxx had a much lower incidence of digestive tract punctures, bleeding and/or blockages than naproxen.

However, another finding in the VIGOR study was that there was a higher incidence of cardiovascular problems in the Vioxx group than the naproxen group. The report concluded that the relationship between cardiovascular distress and the use of Vioxx was still unknown. This outcome surprised many heart experts, who then wanted more research done to assess the cardiac risk Vioxx posed.

Subsequent Studies and Articles

More studies and articles regarding health concerns caused by the use of Vioxx followed. In June 2000, a safety study comparing Vioxx and Celebrex was presented at the European League Against Rheumatism meeting in France. This study showed that almost 60% more patients who took Vioxx rather than Celebrex had elevated systolic blood pressure.

In May 2001, Merck issued a press release entitled "Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx," in response to public concern over the drug's safety. However, in June 2001, an article published in The Lancet, a medical journal, reported that a woman suffered kidney failure after taking Vioxx. Then, in August 2001, a study by three doctors at the Cleveland Clinic, which linked Vioxx to an increase in the risk of blood clots, heart attack and stroke, was published in the Journal of the American Medical Association.

In September 2001, RXintelligence, a nonprofit pharmaceutical research organization founded by the Blue Cross and Blue Shield Association, released results of an analysis of Vioxx studies the FDA had on file at the time which showed a higher incidence of hypertension (high blood pressure) among people taking Vioxx than in those taking Celebrex. Also in September 2001, the American Heart Association, National Stroke Association and Arthritis Foundation requested that Merck test Vioxx to see if it increased the risk for heart attack and stroke.

On September 17, 2001, the FDA sent Merck a warning letter. This letter stated that Merck had misrepresented the safety profile for Vioxx and minimized the potentially serious cardiovascular findings from the VIGOR study. Specifically, Merck's advertisements discounted the fact that the VIGOR study showed that patients taking Vioxx had a four to five-fold increase in myocardial infarctions (MIs) compared to patients on naproxen. The FDA ordered that Merck immediately cease all violative promotional activities and issue a "Dear health care provider" letter to correct false or misleading information.

A February 2002 article in the journal Pharmacology explained that selective COX-2 inhibitors like Vioxx could promote adverse cardiovascular events, such as stroke, pulmonary embolism and heart attack, by creating an imbalance of thromboxane and prostacyclin.

In April 2002, the FDA approved Vioxx for use with rheumatoid arthritis and introduced new labeling requirements and warnings for Vioxx based on the VIGOR study results. Merck continued to defend Vioxx and its safety.

An April 2004 article in the Circulation journal by doctors at the Harvard Medical School concluded that Vioxx use was associated with an elevated risk of acute myocardial infarction. In late August 2004, a poster entitled "Risk of Acute Myocardial Infarction and Sudden Cardiac Death with Use of COX-2 Selective and Non-Selective NSAIDS" was presented at the International Conference on Pharmacoepidemiology and Therapeutic Risk Management in France. The data for this presentation was from a study done by Kaiser Permanente, which found that taking more than 25 mg of Vioxx per day increased the risk of heart attack and sudden cardiac death by 300%. Merck continued to defend Vioxx, issuing a press release on August 26, 2004 stating that Merck stands behind the efficacy and cardiovascular safety of Vioxx.

Vioxx Removed from Market

On September 27, 2004, Merck told the FDA that a safety-monitoring board for the ongoing APPROVe study of Vioxx had recommended that the study be stopped for safety reasons. The APPROVe study showed an increased risk of cardiovascular adverse events, including heart attack and stroke, for individuals taking Vioxx versus those taking a placebo, especially for people who took Vioxx for longer than eighteen months.

On September 30, 2004, Merck announced that it was voluntarily withdrawing Vioxx from both the US and worldwide markets. Between 1999 and 2004, roughly 20 million people in the United States took Vioxx. If you took Vioxx and have questions about the drug, talk to a lawyer who has experience handling Vioxx claims.

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