Side Effects of Fosamax, Other Bisphosphonates To Be Reviewed by FDA

A panel of outside advisers to the FDA are scheduled to meet and review questions about the side effects of Fosamax and other osteoporosis drugs, which may increase the risk of bone fractures and severe jaw problems after long-term use. 

The FDA advisory committee will meet on September 9 to evaluate the risks associated with long-term use of Fosamax, Actonel, Boniva and Reclast.

All of the osteoporosis drugs belong to a class known as bisphosphonates, which are designed to strengthen bones, particularly in women, and prevent or treat the onset of osteoporosis.

Long-term use of oral bisphosphonates has been linked to an increased risk of serious and debilitating jaw problems, known as osteonecrosis of the jaw. The condition causes the jaw bone to decay and rot, often resulting in the need for surgery to remove portions of the jaw.

Hundreds of Fosamax lawsuits over jaw problems have been filed against the drug’s maker, Merck. At least one case has resulted in a jury awarding $8 million last year, after finding that Merck failed to adequately research the potential Fosamax side effects or warn about the risk of jaw necrosis.

More recently, use of the medications, particularly Fosamax, has been linked to a growing number of reports involving spontaneous femur fractures, which often occur with little or no trauma at all. A growing number of Fosamax bone fracture lawsuits are now being filed against Merck, alleging that the drug maker also failed to adequately warn about this risk.

In October 2010, the FDA required the manufacturers of all oral bisphosphonates to add warnings about the risk of bone fractures, placing new information on the label that informs consumers to seek immediate medical attention if they experience new groin pain or thigh pain while taking the drug, which can occur weeks or months before a complete fracture of the femur on Fosamax occurs.

The committee will investigate whether the risk of jaw problems and bone fractures are due to long term use of the drugs and whether there should be a recommended duration for their use. While the committees recommendations are not binding on the FDA, the agency usually follows the guidance of their outside experts.