Vioxx (Rofecoxib) is a COX-2 nonsteroidal anti-inflammatory drug (NSAID) developed by Merck & Co., that was used to treat symptoms of osteoarthritis, acute pain, and painful menstrual cycles.
- The use of NSAIDs is associated in some patients with serious problems from stomach ulcers, including bleeding.
- NSAID medications are also associated with liver damage in some patients.
Some of the biggest historic complaints about Vioxx relate not to its safety, but to cost-effectiveness. Some argue that it was overprescribed for treatment of pain which could be managed at least as well with older, less costly medications.
By the early 2000's, lawyers were asserting that Merck was aware of problems experienced by patients taking Vioxx, including the previously mentioned problems with stomach ulcers and liver damage, but also including heart problems and kidney damage. They alleged that Merck deliberately suppressed information about these side effects from patients and physicians.
Two prominent medical journals published articles that associated Vioxx use with a significantly heightened risk of heart attack. The side effects were believed to be most likely to occur in patients who took Vioxx for fifteen months or longer.
In September, 2004, Merck announced that it was voluntarily recalling Vioxx from the market. This decision followed a test intended to show that Vioxx could help prevent colon polyps, but that indicated that Vioxx users were twice as likely to suffer heart attacks or strokes as compared to subjects receiving a placebo. It was revealed at that time that Merck had withheld information about the safety of Vioxx from both doctors and patients for more than five years, potentially resulting in as many as 140,000 cases of serious heart disease.
A national class action lawsuit against Merck was resolved in 2010 with a $4.85 billion settlement. Merck subsequently settled most of the civil claims pursued by state governments and Washington D.C., for more than $600 million. Merck also pled guilty to a federal crime relating to its marketing of Vioxx across state lines, and paid a penalty of $321.6 million.