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Merck fined $322 million for illegal off-label Vioxx promotion

Consumer Reports News: April 20, 2012 01:30 PM

The U.S. Justice Department hit the drug-maker Merck with a $322 million penalty for illegally promoting the pain reliever rofecoxib (Vioxx) to treat rheumatoid arthritis before it received approval by the Food and Drug Administration for that condition.

Although Vioxx is now banned because it increased the risk of heart attack and stroke, the Justice Department intends the fine to serve as a warning to other drug makers not to illegally promote their medications for "off label" uses—meaning any use not approved by the FDA.

The case also serves as a reminder to consumers to double check whether a medication prescribed by their doctor is FDA approved for its intended use. While off label marketing by drug makers is illegal, doctors can legally prescribe a drug for any purpose they deem appropriate, and they often do. In some cases, this can be beneficial, because certain drugs have solid evidence to support the effectiveness and safety of their off-label use, but many of them do not. (In this case, it should be noted that the class of drugs Vioxx belonged to, known as NSAIDs—nonsteroidal antinflammatory drugs—are an accepted treatment, in general, to ease the symptoms of rheumatoid arthritis.)

Merck's fine is part of a nearly $1 billion settlement announced last year in which the company pleaded guilty to off-label promotion of Vioxx for the treatment of rheumatoid arthritis for nearly three years between 1999 and 2001. The settlement also resolved charges that Merck representatives made false statements about the cardiovascular safety of Vioxx in an effort to increase sales.

Bottom line: Ask your doctor when a prescription is written if the drug has been approved by the FDA to treat your condition. If the answer is "no," ask why he or she thinks it will work better than a drug that's already been approved for your condition.

Read more about off label prescribing, including a list of drugs commonly used off label.

For more on pain relievers, check out our free Best Buy Drugs report on NSAIDs, such as celecoxib (Celebrex), ibuprofen (Advil, Motrin, and generic), and naproxen (Aleve and generic).

U.S. Pharmaceutical Company Merck Sharp & Dohme Sentenced in Connection with Unlawful Promotion of Vioxx [ U.S. Department of Justice ]

Steve Mitchell

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