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FDA Panel: Calcitonin Salmon Should Not Be Used for osteoporosis

Filed March 6th, 2013 admin

If the U.S. Food and Drug Administration (FDA) follows the recommendation of its advisory panel, the agency will no longer support the marketing of calcitonin salmon as a treatment for osteoporosis in post-menopausal women.

The advisory panel voted 12-9 that the potential increase in the risk of cancer associated with of calcitonin salmon products outweighs its benefits in treating bone-thinning associated with osteoporosis, The Chicago Tribune said. Calcitonin salmon is a version of the hormone calcitonin that is found in salmon. Popular versions of calcitonin products include Novartis AG’s Miacalcin injection and nasal spray and Unigene Laboratories Inc’s nasal spray. Generic calcitonin products are also available, said The Chicago Tribune.

The panel was much more decisive in a 20-1 vote that any company developing new calcitonin salmon products must prove they are effective in reducing fracture risk, The Chicago Tribune said. The panel’s recommendations come in wake of an FDA staff review that found significant questions remain over whether calcitonin salmon is effective in reducing bone fractures.

Last July, European regulators recommended that long-term use of calcitonin be halted after a review found evidence of an increased risk of cancer with long-term use of the drugs, according to The Chicago Tribune. The regulators also ruled that the increased cancer risk outweighed any benefit the drugs can provide and should not be used in the treatment of osteoporosis.

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