FDA ASKED MERCK TO WARN OF FOSAMAX RISK IN 2004

Robert Blanchard

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A lot of doctors were surprised to learn that the FDA had asked Merck of the risk of osteonecrosis of the jaw and Fosamax back in August 2004 - - right at the same time Merck was forced by circumstances to pull Vioxx from the shelves. Merck has yet to put any information in its WARNINGS about the risk of osteonecrosis of the jaw and Fosamax.

After my partner Tim O'Brien's article appeared in the Wall Street Journal, a lot of doctors were surprised to learn that the FDA had asked Merck of the risk of osteonecrosis of the jaw and Fosamax back in August 2004 - - right at the same time Merck was forced by circumstances to pull Vioxx from the shelves. You can find FDA's review of its adverse event data at the following site; simply cut and paste into your browser and this will take you directly into the FDA's review: http://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4095B2_03_04-FDA-TAB3.pdf. Merck still hasn't put any information in its WARNINGS about Fosamax and osteonecrosis of the jaw in its prescribing information and this continues to confuse a lot of prescribing physicians.