The U.S. Food and Drug Administration (FDA) issued a Fosamax® warning and requested a label change to be made on all bisphosphonates, Oct. 13, 2010. The warning alerts healthcare providers and consumers of a potential increased risk of atypical thigh fractures in patients who use osteoporosis drugs such as Fosamax® for long periods of time.
The agency also requested that a label change be made to Fosamax® and all other drugs in its class, known as bisphosphonates, to alert patients of a possible risk of atypical femur fractures.
According to the FDA, many patients who have been treated with Fosamax® and other bisphosphonates have suffered from fractured thigh bones. A cause and effect relationship has not been confirmed.
Bisphosphonates included in the FDA warning include Fosamax®, Fosamax® Plus D, Actonel®, Actonel® with Calcium, Boniva® and Atelvia®. Generic forms are also involved.