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Fosamax: The Hiding of a Public Hazard 
Law.com | October 5, 2006
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. |