A panel of advisers to the Food and Drug Administration recommended on Tuesday that the agency no longer support the marketing of calcitonin salmon as a treatment for osteoporosis in post-menopausal women.
The panel voted 12-9 that the benefit of calcitonin salmon products in treating bone-thinning associated with osteoporosis is outweighed by a potential increase in the risk of cancer.
Calcitonin salmon is a man-made version of the hormone calcitonin that is found in salmon.
Calcitonin products include Novartis AG's Miacalcin injection and nasal spray and Unigene Laboratories Inc's nasal spray. Privately held Upsher Smith Laboratories Inc distributes Unigene's product in the United States. Generic calcitonin products are also available.
The panel voted 20-1 that companies developing new calcitonin salmon products must prove they are effective in reducing fracture risk.
The result follows an FDA staff review that found significant questions remain over whether calcitonin salmon is effective in reducing fractures.
Last July, European regulators recommended that long-term use of calcitonin be curtailed after a review found evidence of a small increased risk of cancer with long-term use of the drugs.
They ruled that the benefits of calcitonin-containing medicines did not outweigh their risks in the treatment of osteoporosis and that they should no longer be used for this condition.
They recommended that the drugs should only be authorized for short-term use in Paget's disease, a bone disorder; for acute bone loss due to sudden immobilization; and for excess calcium in the blood caused by cancer.
(Reporting By Toni Clarke in Washington; Editing by Leslie Adler)