Osteoporosis fracture risk from bisphosphonates?

Osteoporosis: Is a fracture risk due to a longer prescription of so-called bisphosphonates?

The US Food and Drug Administration (FDA) warns against potential risks of atypical femur fractures in the treatment of long-term bisphosphonates in osteoporosis. For this reason, warnings should be included in the subject-related information, so the requirement the supervisory authority.

Bisphosphonates belong to a group of drugs used for diagnostic and therapeutic purposes in bone and calcium metabolism diseases. Fewer than one percent of atypical femoral fractures in hip and femoral fractures, so the FDA. Predominantly, atypical femur fractures have been observed in patients with osteoporosis. However, it is still unclear whether a long-term administration of the drugs is actually responsible for the type of fractures. The drug experts are now investigating the safety and efficacy of bisphosphonates in long-term osteoporosis therapies. It should also be determined more accurately how often the fractures occurred in the patients.

Recent studies on long-term use in osteoporosis have led to a suggestion in the WHO „Pharmaceuticals Newsletter in the category „Safety of medicines“ to the publication by the Medicines and Healthcare products Regulatory Agency of possible atypical fractures of the femoral shaft (corpus ossis femoris).

The FDA noted that the warnings in the product information refer only to bisphosphonates that have been approved for the treatment and prevention of osteoporosis. Patients should also be informed about the possible risks of developing fractures.

To date, the FDA has not been able to provide information on the optimal duration of treatment. However, the agency suspects that the atypical fractures of the femur may only occur after a treatment period of around five years. That too should find out the evaluation. (sb, 15.10.2010)