Vioxx Recall
Vioxx (rofecoxib) is part of a class of prescription drugs called COX 2 inhibitors, which are also known as non-steroidal anti-inflammatory drugs (NSAIDs). These drugs work by impeding the production of certain chemical messengers responsible for pain and swelling by blocking the COX 2 enzyme. Vioxx received FDA approval in March 1999 to help relieve the signs and symptoms of osteoarthritis, manage acute pain in adults and treat menstrual symptoms. The drug was later approved to provide relief for adults and children afflicted with rheumatoid arthritis.
On September 30, 2004, Vioxx’s manufacturer, Merck & Co., Inc. voluntarily removed the drug from the market after a study showed the drug increased a patient’s risk of dangerous cardiovascular problems, including heart attacks and strokes. The FDA did not demand that Merck & Co., Inc. recall Vioxx, but agreed with the manufacturer’s actions after reviewing the study’s results.
Consumers who were prescribed Vioxx expected Merck to manufacture a safe, effective drug. Allowing this drug to remain on the market, even when the cardiovascular risks were known, shows the company’s negligence in protecting consumers. This failure to properly warn consumers about the dangerous side effects of Vioxx may make Merck & Co., Inc. liable for any injury or death associated with the drug. Contact the law offices of Levin, Simes, Kaiser & Gornick to learn more about your rights as a victim and the possibility of compensation.
Vioxx Side Effects
Merck’s recall of Vioxx was based on the Adenomatous Polyp Prevention on Vioxx (APPROVe) trial. This study compared a placebo to 25mg tablets of Vioxx to determine if the drug effectively prevented the recurrence of colon polyps. The study was halted after it was discovered that the patients taking Vioxx had an increased risk of cardiovascular problems, including strokes and heart attacks.
This was not the first indication that Vioxx increased the risk of cardiovascular problems. In April, 2002, the FDA required Merck to include a warning on the drug’s label after analyzing the results of the Vioxx GI Outcomes Research (VIGOR) study. This study was designed to show the connection between Vioxx patients and stomach ulcers. While the study found Vioxx users suffered fewer stomach ulcers than users of naproxen, a different NSAID, there was a higher rate of serious cardiovascular problems in the Vioxx group.
The fact that Merck continued to manufacture and market Vioxx for more than two years after discovering a link to cardiovascular problems suggests that the company failed to properly protect its customers. The decision to continue marketing the drug may have been based in part on Vioxx’s profitability. After FDA approval, Vioxx was widely prescribed throughout the world, and in 2003 its sales totaled $2.5 billion.
Vioxx – Legal Recourse
Merck & Co., Inc. has paid more than $1 billion to settle lawsuits associated with patients experiencing cardiovascular problems after taking Vioxx. If you or someone you know has experienced symptoms associated with cardiovascular problems, you may be entitled to compensation. The lawyers of Levin, Simes, Kaiser & Gornick have decades of experience protecting victims in personal injury cases. To learn more about your rights as a victim, contact their offices at (800) 901-4001.
Levin Simes Kaiser & Gornick, LLP
44 Montgomery Street, 36th floor
San Francisco, CA 94104
Ph: 1.800.901.4001
Fax: 415.981.1270
