In September 1995, the U.S. Food and Drug Administration approved Merck’s compound alendronate for various uses, including the treatment of osteoporosis and Paget’s Disease. Alendronate is marketed by Merck as Fosamax. It is one of Merck’s biggest sellers, with approximately $3.5 billion per year in sales.
Since Fosamax was released, there have been a significant number of reports of osteonecrosis of the jaw (“ONJ”) among users of Fosamax. On Aug. 25, 2004, the FDA posted its Office of Drug Safety Post-Marketing Safety Review on bisphosphonates, including those used in chemotherapy and those contained in Fosamax. This was an epidemiologic review of the FDA adverse events database conducted by the FDA’s Division of Drug Risk Evaluation. As a result of the review, the FDA observed that there was a risk of ONJ that was not confined to bisphosphonates used for chemotherapy. The FDA’s review indicated that the ONJ was a class effect, which specifically extended to the oral bisphosphonate, Fosamax.
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