Vioxx

Merck announced on Thursday September 30, 2004, that it would be withdrawing its arthritis drug Vioxx globally after a colon cancer study confirmed long-standing concerns that the drug raises the risk of heart attack and stroke. The study was stopped in mid-course due to the results which confirmed that Vioxx risks outweighed its benefits for any class of patients. This AAPPROVEe study (which stands for the Adenomatous Polyp Prevention on Vioxx study) was a three-year prospective, randomized, placebo-controlled clinical trial designed to evaluate the efficacy of Vioxx 25 mg. in preventing recurrence of colorectal polyps in patients with a history of colorectal disease.

The Approve study confirmed that there was an increased relative risk of confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in patients taking Vioxx as opposed to those on placebo. The APPROVe study was overseen by the U.S. Food and Drug Administration and suggested that patients taking Vioxx faced a 50 percent greater risk of heart attacks and sudden cardiac death than those taking Pfizer Inc.=s Celebrex. Celebrex was and is clearly a safer alternative remedy with equal or greater benefits than Vioxx and a far less dangerous risk profile.

Announcing the recall at a September 30, 2004, press conference Merck CEO Raymond Gilmartin, said: "[w]e are taking this action because we believe it best serves the interests of patients," "[a]lthough 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." Gilmartin further said people who are currently taking Vioxx should consult their healthcare provider about the ongoing treatment using Vioxx and should also obtain information on alternative treatments.

Merck previously marketed Vioxx, despite knowledge in its clinical trials and post-marketing reports associating Vioxx with hypertension and/or hypertension-related adverse health effects, Merck marketed and promoted Vioxx as safe and effective for persons with hypertension, or persons who had risk factors for stroke or cardiac problems.

Merck launched Vioxx in the United States in 1999 and it has been marketed in more than 80 countries. The drug's worldwide sales in 2003 were $2.5 billion. Vioxx had sales in 2003 of $2.55 billion.

Taking more than 25 mg per day of rofecoxib (Vioxx) is linked to a tripling of the risk of heart attack, said a paper presented in August at the International Society for Pharmacoepidemiology Conference in Bordeaux, France.

Researchers analyzed data from the HMO Kaiser Permanente for all patients prescribed COX-2 inhibitors or non-steroidal anti-inflammatories. Patients on higher doses of rofecoxib increased their heart attack risk by a factor of 3.15. No increase was found in patients taking another COX-2 inhibitor, celecoxib (Pfizer=s Celebrex). Kaiser intends to re-evaluate use of this drug based on this information.

The manufacturer disagreed with the conclusions of the study. Peter S. Kim, PhD, president of Merck Research Laboratories. said: A[o]bservational analyses do not have the rigor of randomized, controlled clinical trials. ... Based on the data that are available from our clinical trials, Merck stands behind the efficacy and safety, including cardiovascular safety, of Vioxx.@

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