FDA Panel Sees Risk in Long-Established Osteoporosis Drug


FDA Panel Sees Risk in Long-Established Osteoporosis DrugThe U.S. Food and Drug Administration (FDA) says that an osteoporosis  drug used since the 1980s 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. Novartis and Upsher-Smith market calcitonin salmon in nasal spray form as Miacalcin and Fortical, respectively.  At a March 5 meeting, an FDA advisory panel voted 12-9 that the risks of the inhalable osteoporosis drug outweigh its benefits in treating brittle bones.

Health authorities around the world have been reviewing the drug’s safety after two recent studies showed a slightly higher rate of cancer among patients taking calcitonin pills. Calcitonin salmon is a man-made version of the hormone calcitonin found in salmon. In addition to the nasal spray and pills, the drug is also available as an injection and it is used 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.

In July 2012, 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 they 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.