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March 1 (Reuters) - Staff reviewers for the U.S. Food and Drug Administration said that a potential increased risk of cancer with drugs containing calcitonin salmon appears plausible.
In briefing documents released on Friday, the reviewers said the risk raises concerns about the overall risk versus benefit of calcitonin products to treat osteoporosis in postmenopausal women.
Calcitonin products are made by Novartis AG and Unigene Laboratories Inc. Upsher Smith Laboratories Inc distributes Unigene's product in the United States. Generic calcitonin products are also available.
The reviewers said significant questions remain on calcitonin salmon's effectiveness in reducing fractures in the treatment of postmenopausal osteoporosis.