Dr. Sharpe was stunned to hear that Amanda would be forced to leave school just because one medication was not available. He went to the Food and Drug Administration’s web site, where he found their initial press announcement.
Sept. 30, 2004*
FDA Issues Public Health Advisory on Vioxx; Manufacturer Voluntarily Withdraws Product
The Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.
Merck is withdrawing Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps.
“Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product,” said Acting FDA Commissioner Dr. Lester M. Crawford. “The risk that an individual patient would have a heart attack or stroke is very small. Yet their study does suggest patients taking Vioxx chronically face twice the risk of a heart attack compared to patients receiving a placebo.”
In June 2000, Merck had submitted to FDA a separate safety study that showed an increased risk of heart attacks and strokes in patients taking Vioxx chronically for arthritis, compared to patients taking Aleve. After reviewing the results of the earlier study, FDA required additional label and prescribing information on Vioxx, but did not recommend withdrawal.
FDA approved Vioxx in 1999 for the reduction of pain and inflammation caused by osteoarthritis, rheumatoid arthritis, and acute pain in adults. It is a Cox-2 selective NSAID; other NSAIDs target both Cox-1 and -2. When Vioxx was approved, it was hoped that it would have a lower incidence of gastrointestinal ulcers and bleeding than other NSAIDs like Motrin (ibuprofen) and Aleve (naproxyn).
*Based on the original FDA press release, which has been modifed for the purposes of this case study.
Originally published at http://www.sciencecases.org/vioxx/vioxx2.asp
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