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FDA Advisers Call for Revised Labels for Osteoporosis Drugs
Date:9/9/2011

s, said length of treatment should be considered on an individual basis. His study suggested patients at mild risk might discontinue drug treatment after five years for as long as no fractures occurred and no bone loss was evident. Higher-risk patients could take the drugs for 10 years and perhaps then take a "holiday" from bisphosphonates of one or two years.

"It would probably be helpful if FDA or some official organization could provide guidelines on duration of treatment, details of drug holidays, etc., but there is probably not enough information in the literature for recommendations based on science," Watts said before Friday's vote.

Common bisphosphonates are taken in tablet form or by injection. They include: Fosamax (alendronate sodium) made by Merck & Co., Inc.; Actonel and Atelvia (risedronate sodium) made by Warner Chilcott; Boniva (ibandronate sodium) from Roche Therapeutics, Inc.; and Reclast (zoledronic acid) from Novartis Pharmaceuticals Corp.

More information

For more information on osteoporosis, visit the U.S. National Library of Medicine.

SOURCES: Elizabeth Shane, M.D., past president, American Society for Bone and Mineral Research, endocrinologist and professor of medicine, Columbia University, New York City; Nelson B. Watts, M.D., director, University of Cincinnati Bone Health and Osteoporosis Center, Cincinnati, Ohio; Associated Press; Bloomberg News


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