On September 30, 2004, Merck & Co. announced the voluntary worldwide recall of its blockbuster arthritis drug Vioxx® (rofecoxib). The Vioxx recall marks the largest drug recall in history. More than two million people worldwide took Vioxx. The recall has left thousands of Vioxx users confused about treatment options. The manufacturer and the FDA advise patients to consult their doctor about alternatives.
Vioxx was approved by the U.S. Food and Drug Administration (FDA) in 1999 for the reduction of pain and inflammation caused by oeteoarthritis, as well as for acute pain in adults, and for the treatment of menstrual pain. It was later approved to treat signs and symptoms of rheumatoid arthritis in adults and children. Vioxx belongs to a class of drugs known as COX-2 inhibitors. When these drugs were first introduced a few years ago, they were thought to be safer, more effective, and less prone to causing gastrointestinal side effects than traditional non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen and naproxen. However, several studies have questioned the cardiovascular safety of Vioxx and other COX-2 inhibitors known as Celebrex® and Bextra®.
Merck & Co. announced the recall after a study confirmed previous studies. Merck halted the study after it discovered that participants taking Vioxx for 18 months had twice the risk of heart attack than participants taking placebos. Antoher study examined the records of 1.39 million Kaiser Permanente patients, including 26,748 treated with Vioxx. That study found that high doses of Vioxx tripled risks of heart attacks and sudden cardiac death. In an October 2004 article, the Wall Street Journal cited an unreleased study estimating that Vioxx may have led to as many as 27,000 heart attacks and sudden cardiac deaths. These recent studies confirm the findings of the studies published as early as 2000, including the Vioxx Gastrointestinal Outcomes Research Study (VIGOR) which compared Vioxx and traditional NSAID naproxen among 8,000 patients. The VIGOR Study found twice the risk of cardiovascular problems, including heart attack, stroke, and sudden death, among Vioxx patients when compared to patients taking naproxen.
These recent studies confirm the findings of other studies published as early as 2000, including the Vioxx Gastrointestinal Outcomes Research Study (VIGOR) which compared Vioxx and the traditional NSAID naproxen among 8,000 patients. The VIGOR Study found twice the risk of cardiovascular problems, including heart attack, stroke and sudden death among Vioxx patients when compared to patients taking naproxen.
Many critics, including Dr. Eric Topol of the Cleveland Clinic, have publicly voiced their outrage at Merck and the FDA for not taking action sooner given the numerous early warning signs. The recall has also prompted the call for Congressional hearings concerning the monitoring of drug safety.
Lopez Hodes currently is representing individuals who suffered heart attacks or strokes, and families of individuals who died as a result of their ingestion of Vioxx. Members of the firm are taking active roles in the litigation nationwide, including Ramon Lopez and Steve Skikos, who are members of the Plaintiffs' Executive Committee in the California Coordinated Vioxx litigation, and both serve on the Discovery Committee in the Vioxx federal multidistrict litigation pending in the U.S. District Court for the Eastern District of Louisiana.
If you or someone you know has suffered a cardiovascular event, including heart attack, ischemic stroke, or sudden death while using Vioxx, and you would like to consult Lopez, Hodes, Milman & Skikos regarding a possible claim, click on the link "Do You Have A Case" Questionnaire . You will receive a response as soon as possible and certainly within two business days.
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