FDA Continues to Review the Safety of Bisphosphonates
The U.S. Food and Drug Administration (“FDA”) announced that an advisory committee will meet on September 9, 2011 to review whether long-term bisphosphonate use puts patients at an increased risk for sustaining atypical femur fractures and osteonecrosis of the jaw (“ONJ”). Given that an estimated 5 million Americans use bisphosphonates for the treatment of osteoporosis, the FDA has been especially proactive about reviewing the drugs’ safety as a slew of studies continue to find that these drugs put users at an increased risk for dangerous side effects, such as atypical femur fractures and ONJ. For example, in response to the onslaught of research, the FDA has previously issued warnings, and required manufacturers to change the drugs’ labeling. Gathering a panel of outside advisors to convene this fall is just the latest action in a series of commendable steps to address what has become a widespread public health and safety issue. The committee is expected to evaluate the gravity of the risks associated with long-term bisphosphonate use as well as issue a recommendation as to whether bisphosphonate use should be limited to a particular duration. Previously, the FDA has advised patients to consider taking a drug holiday after five years of continuous bisphosphonate therapy. Specifically, the advisory panel will review the safety of Fosamax, Actonel, Boniva and Reclast. Currently, Merck, the manufacturer of Fosamax, is defending thousands of lawsuits filed by victims who were injured as a result of taking the drug.
We will continue to keep you posted on any developments occurring in the FDA’s investigation, as well as the Fosamax litigation.