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Merck Denies the Link Between ONJ and Fosamax

Jaw Bone Death Lawsuit Information

It seems that the end of 2008 and beginning of 2009 has brought new concerns about Merck & Co.'s popular osteoporosis drug, Fosamax. This is not the first time that the Fosamax drug has received bad press after a study was published in a national medical journal and it is not the first time that Merck has been prepared with a quick response to the news.

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Can Fosamax lead to Osteonecrosis of the Jaw?

According to the FDA and the Journal of the American Dental Association, the possibility exists that Fosamax can lead to jaw bone death, or osteonecrosis of the jaw. In 2005, the FDA requested that the manufacturers of bisphosphonate drugs such as Fosamax include a warning label about the possible link between the drug and osteonecrosis of the jaw.

On January 1, 2009, the Journal of the American Dental Association published a study completed by the University of Southern California School of Dentistry in Los Angeles that found a link between osteonecrosis of the jaw and bisphosphonate drugs such as Fosamax. Researchers studied just over 200 patients with dead jawbone disease and found that 4% of the patients studied where taking Fosamax and had a dental procedure completed. The Journal of the American Dental Association found the research convincing enough to publish it and many doctors and dentists are warning patients to complete any major dental work prior to beginning Fosamax treatment and to inform their dentist about any bisphosphonate drugs that they are taking.

Merck's Response to the Journal of the American Dental Association Article

Merck & Co. promptly responded to the study completed by the University of Southern California School of Dentistry that was published in the Journal of the American Dental Association. The drug manufacturer suggested that the finding were discredited by the larger and more in depth studies that had already been performed. Specifically, Merck is quoted as saying, "The study...has material methodological flaws and scientific limitations, making it unreliable as a source for valid scientific conclusions regarding the prevalence of [osteonecrosis of the jaw] in patients taking alendronate [Fosamax]...In controlled clinical trials involving more than 17,000 patients, contributing as much as 10 years' data with alendronate, there have been no reports of [osteonecrosis of the jaw]."

The statement did not acknowledge the FDA's 2005 request to add a warning about osteonecrosis of the jaw to its warning label and Merck's compliance with that request.

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Will this response satisfy patients who are concerned about the possible side effects of the drug and physicians who are uneasy prescribing it? It is difficult to say, especially when public opinion of the drug may be swayed by the Journal of the American Dental Association publication and a letter that was published almost simultaneously in the revered New England Journal of Medicine that found a potential link between esophageal cancer and Fosamax.

Patients who are taking Fosamax and who have suffered negative side effects should immediately contact their physician and a Fosamax lawyer who can advise the patient of his or her rights.

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