European drug regulators have announced that they are conducting a safety review into the potential risk of stress fractures from side effects of Fosamax and other bisphosphonate-based drugs, which are commonly used to strengthen the bones.
The European Medicines Agency announced the Fosamax probe during a meeting last week of the Committee for Medicinal Products for Human Use (CHMP). The committee announced it was looking into atypical stress fractures in patients taking bisphosphonates following a review of recent studies and post-marketing reports that suggest a possible link between the class of medications and stress fractures.
In recent months, a number of low-trauma bone breaks among Fosamax users have been reported in the media, usually involving the thigh bone or femur, which is one of the strongest bones in the human body. The CHMP will review the body of literature on Fosamax bone fractures and then determine whether it is a class effect of all bisphosphonates, and if so, how that factors into the risks and benefits analysis of those drugs.
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 stress 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 broken femurs. 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.