- Background Document for Meeting of Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee, September 9, 2011: “This meeting is being convened to review and discuss the available data regarding the long term (greater than 3 – 5 years) use of bisphosphonates for the treatment and/or prevention of osteoporosis. In light of recent safety events that appear to potentially be associated with the long-term use of bisphosphonates, FDA believes that it is important to address questions regarding efficacy and the optimal duration of use for bisphosphonates.”
- “From a safety perspective, the committee will be asked to discuss whether there is sufficient evidence to support an effect of long-term use of bisphosphonates therapy targeted at preventing and/or treating osteoporosis on the risk of developing osteonecrosis of the jaw, atypical fractures or esophageal cancer. Should the committee conclude there is a risk, they will be asked to discuss if there is sufficient evidence of an optimal duration use that would minimize these risks.”
- WSJ – FDA Panel: Won’t Make Treatment Recommendation For Osteoporosis Drugs
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