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Vioxx, an NSAID medication, has been one of three COX-2 inhibitors on the market, along with Celebrex and Bextra. The FDA approved it in 1999 for treatment of arthritis and menstrual pain, but after warnings and a recall, manufacturer Merck has shielded multiple lawsuits concerning the drug’s side effects and marketing campaign.
After appearing on the market, Vioxx was marketed in 80 countries and eventually used by 84 million people. In comparison to other NSAIDs, Vioxx was marketed as being safer for gastrointestinal issues.
In five years, however, Vioxx became associated with thousands of heart attacks, strokes, and deaths. Once Merck took the product off shelves in 2004, 38,000 people died from related heart attacks, 160,000 were injured, and many more have had ongoing heart problems.
Prior to the recall, multiple studies confirmed a correlation between Vioxx usage and cardiovascular concerns. Adenomatous Polyp Prevention on Vioxx (APPROVe) originally examined the drug’s effect on the reoccurrence of neoplastic polyps, but after three years, researchers discovered an increase in complications after subjects took the drug for 18 months.
Vioxx Gastrointestinal Outcomes Research (VIGOR) discovered the medication increased patients’ chances of a fatal heart attack or stroke. Merck, in response, changed the label to include information about this risk.
A second study, cited in the FDA’s 2004 recall, found that patients taking Vioxx have a 50-percent greater chance of a heart attack. Patients taking three times the recommended dosage have the greatest risk. In comparing Vioxx with traditional NSAID Naproxen, researchers observed 8,000 patients and found that those taking the COX-2 inhibitor had double the risk of cardiovascular problems.
Merck has since been served with two major lawsuits: Multi-district litigation in a Louisiana court and a shareholder claim. While Merck settled the latter without admitting fault, plaintiffs in the latter allege the manufacturer’s false statements in its marketing materials resulted in billions of dollars lost. Merck has since settled for $12 million and has had made sweeping corporate changes, including greater emphasis on marketing oversight and safety.
After a seven-year investigation, the Department of Justice further pursued Merck for its marketing practices, with the drug manufacturer pleading guilty to federal misdemeanor charges that its advertisements influenced doctors to prescribe the medication. The company paid $950 million in 2011 to settle the claim.