A panel of experts convened by the U.S. Food and Drug Administration (FDA) says that a long used osteoporosis drug should no longer be used because there is insufficient evidence that it works, and it may increase the risk of cancer.
The drug, calcitonin salmon, has been prescribed for osteoporosis in postmenopausal women since the 1980s, the Associated Press (AP) reports. The drug is marketed as a nasal spray by Novartis as Miacalcin and by Upsher-Smith as Fortical. The FDA panel voted 12-9 that the risks of the inhalable drug outweigh its benefits when used to treat brittle bones. Calcitonin salmon is a man-made version of the hormone calcitonin found in salmon.
Health authorities in a number of countries have been reviewing the drug’s safety after two recent studies showed a slightly higher rate of cancer among patients taking calcitonin pills. The drug is also available as an injection to treat other conditions, including Paget’s disease, a bone disorder; acute bone loss due to sudden immobilization; and excess calcium in the blood caused by cancer.
Last July, the European Medicines Agency (EMA) concluded that calcitonin should no longer be used to treat osteoporosis, due to the drug’s cancer risk, the AP writes. An FDA memo released prior to Tuesday’s panel meeting said that while it’s difficult to draw a direct link between the drug and cancer, “the potential for a cancer risk with calcitonin salmon therapy cannot be ignored. The majority of all calcitonin salmon trials showed an increased risk estimate.”
The FDA approved the Novartis and Upsher-Smith drugs based on studies showing that the drugs increased bone mineral density, but no studies have definitely shown that higher density actually reduces bone fractures, the AP reports. The FDA panel, in a nearly unanimous vote, said that any future calcitonin drugs should be required to show real effectiveness in preventing bone fractures. The FDA is not required to follow panel recommendations, though it often does.