The FDA and two of its advisory committees have been debating whether to recommend limiting the duration of use of bisphosphonates in order to prevent atypical femoral fractures and possibly other side effects of the drugs. The agency produced a 182-page background document on this subject for a joint meeting of the Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committees held on September 9, 2011 (www.fda.gov). The document concluded that there is no clear evidence, with regard to fractures, of benefit or harm in continuing the drugs beyond 3-5 years. The two advisory committees recommended that the labels for these drugs clarify their duration of use; they did not specify what that duration should be. A Treatment Guidelines from The Medical Letter issue on Drugs for Postmenopausal Osteoporosis will be published in November.
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In Brief: Duration of Use of Bisphosphonates
Published: October 3, 2011
The FDA and two of its advisory committees have been debating whether to recommend limiting the duration of use of bisphosphonates in order to prevent atypical femoral fractures and possibly other side effects of the drugs. The agency produced a 182-page background document on this subject for a...
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