FDA: Benefits Of Salmon Hormone May Not Outweigh Cancer Risks

Bloomberg News (3/1, Edney) reported that according to a Food and Drug Administration report, a “salmon hormone used to treat post-menopausal osteoporosis may not reduce bone fractures enough to outweigh the drug’s cancer risks.”

The agency said “three studies on oral, injectable and nasal calcitonin-salmon formulations sold by Novartis AG (NOVN), Upsher-Smith Laboratories Inc. and other companies showed unreliable or disappointing results.” FDA staff said, “This lack of effectiveness when combined with the potential for a cancer risk associated with calcitonin salmon therapy raises concerns about the overall risk and benefit assessment.”

Reuters (3/1, Clarke) reported that an advisory panel to the FDA will meet on March 5 and make a recommendation to the agency on the continued marketing of products containing calcitonin salmon to treat osteoporosis in postmenopausal women. European regulators recommended last July that the extended use of calcitonin be reduced after evidence revealed a link between the hormone and an small, elevated risk in cancer.