Fosamax and its class of osteoporosis drugs increases the chances of a bone fracture, according to a warning to doctors and patients released by the Food and Drug Administration (FDA) on Wednesday. The FDA has asked for a change in how the Warnings and Precautions section is labeled on all bisphosphonate products. Bisphosphonates are a class of drugs primarily used to treat the symptoms of osteoporosis, a bone disease that weakens the bone's density and can make it more likely to break. According to the FDA, this class of drugs must now be accompanied by a medication guide that alerts people taking the drug of its risks.
The FDA warning comes as the result of a rare type of bone fracture repeatedly occurring in patients receiving these drugs. Currently, many doctors believe that the risk of bone fracture are rare and more closely associated with patients who have long-term bisphosphonate use. "There is a dull aching thigh or groin pain that occurs weeks or months before the fracture occurs," Dr. Sandra Kweder, deputy director, Office of New Drugs in the FDA's Center for Drug Evaluation and Research. "It is predominantly in patients who have taken bisphosphonates for five years or more."
The changes to be made on the warning labels are will only occur on bisphosphonates that have been approved for osteoporosis treatment. These drugs include: Actonel, Actonel with Calcium, Atelvia, Boniva, Fosamax, Fosamax Plus D and all of their respective generic versions. Included in the changes of warning labels are the injectable osteoporosis drugs like Boniva and Reclast Reclast. Bisphosphonates that are labeled for use in the treatment of other diseases will not be affected.
The FDA first began studying the side-effects of bisphosphonate use and the frequency of the bone and femur fractures in March. The FDA was also made aware of and reviewed a report issued by the American Society for Bone Mineral Research Task Force. The report made a strong recommendation to add additional labeling, in addition to adding a system that would identify and track patients with femur and bone breaks.
