Link Between Fosamax and Jaw Decay Found in New Study

New research appears to provide further evidence linking side effects of Fosamax to a risk of serious and debilitating jaw bone decay. 

In a study published in the August issue of The Journal of Clinical Endocrinology & Metabolism, Taiwanese researchers compared Fosamax to the bone drug Evista, finding that users of Fosamax were seven times more likely to be diagnosed with osteonecrosis of the jaw (ONJ), a rare disorder involving the decay and death of bone in the jaw.

Fosamax (alendronate sodium) is a blockbuster osteoporosis medication that was introduced by Merck in 1995. Before it became available as a generic in 2008, the medication generated more than $3 billion in annual sales and was used by millions of Americans.

In recent years, a number of Fosamax lawsuits have been filed on behalf of former users of the drug diagnosed with ONJ, following a number of studies that suggested a link between Fosamax and jaw decay. In some cases, patients have to have their jaw surgically removed.

This latest reseach involved a review of electronic medical records involving patients who began taking either Fosamax or Evista (raloxifene) and developed ONJ in the Taiwanese population between January 2002 and April 2012.

Researchers found that Fosamax users were 7.42 times more likely to suffer jaw bone decay than those who took Evista. The incident rate increased over time, with only 0.23% of users developing ONJ after the first two years, to just under 1% after a decade of use. The researchers determined that the overall incident rate was 0.55% over a 12 year period for Fosamax users, resulting in 283 cases of ONJ per 100,0000 persons per year.

Merck at one point faced more than 1,100 osteonecrosis of the jaw lawsuits filed by former Fosamax users who developed the condition. In December 2013, the drug maker agreed to pay $27.7 million in Fosamax settlements to resolve the litigation, but continued to deny any liability for failure to provide adequate warnings for users and the medical community.

The drug maker now faces a number of Fosamax femur fracture lawsuits, alleging that inadequate warnings were provided about the risk of atypical bone breaks, which have been reported among users while taking a step or falling from standing height or less.