An expert task force is recommending that new warnings be added about the risk of rare thigh bone fractures from Fosamax and other bisphosphonate medications.
In a study published in the Journal of Bone and Mineral Research (JBMR), an expert panel convened by the American Society of Bone and Mineral Research has determined that while no direct link has been established between bisphosphonate medications like Fosamax and femur fractures, there appears to be enough of a connection to merit warning the public about the risk.
“Most of the patients who experienced these atypical femur fractures had been taking bisphosphonates for more than five years,” observed lead study author and task force co-chair Dr. Elizabeth Shane, of Columbia University. “However, we are concerned that there may be a relationship between these fractures and long-term bisphosphonate use and, although the risk is low, we want to make sure that people know about the warning signs.”
Fosamax has come under scrutiny recently due to an increasing number of reports of low-trauma bone breaks among Fosamax users, usually involving the thigh bone or femur, which is one of the strongest bones in the human body.
In a review of previous research on Fosamax thigh fractures, the task force found that there was enough evidence to lend a “biological plausibility” to a connection between the long-term use of Fosamax and other bisphosphonates and sudden femur fractures. The bone specialists found that the fractures were still very rare, especially when compared to the number of other bone breaks that are prevented by the use of bisphosphonates.
Despite that, the researchers said that there is a concern that a lack of awareness and underreporting of Fosamax femur fractures is hiding the true number of bone breaks. If the FDA were to act on the researchers’ calls for femur fracture label warnings, other drugs that would get the warning would include Roche’s Boniva, Novartis’s Reclast and Warner Chilcott’s Actonel.
In addition to the label warnings, the task force is calling for the medical and scientific community to develop specific diagnostic and procedural codes be developed to better identify the clinical and genetic risk factors that might cause Fosamax fractures, as well as the best methods to treat these breaks.
Fosamax (alendronate sodium), Boniva (ibandronate) and Reclast (zoledronic acid), are all members of a class of drugs known as bisphosphonates, which are prescribed for treatment of osteoporosis. Fosamax, which is the most widely used of the three medications, was approved by the FDA in October 1995, and has been used by more than 20 million people. The drug generated over $3 billion in annual sales for Merck before it became available as a generic last year.
A number of Fosamax thigh bone fracture lawsuits have been filed against Merck alleging that the drug maker failed to adequately research their medication or warn users about the risk of the bone breaks. The drug maker also already faces hundreds of lawsuits over Fosamax jaw side effects, involving a rare condition known as osteonecrosis of the jaw (ONJ), which cause portions of the jaw to decay or die.