In a March 5 meeting, a panel of advisors to the Food and Drug Administration (FDA) voted 12 to 9 that the potential increased risks of cancer associated with the drug calcitonin salmon outweighed its benefits when used to treat brittle bones. The inhalable drug – prescribed for postmenopausal women for osteoporosis since the 1980s – is marketed as Miacalcin and Fortical nasal sprays.
Associated Press reports that an internal memo released ahead of the March 5 meeting said that it was difficult to draw a direct link between the drug and cancer. However, “the potential for a cancer risk with calcitonin salmon cannot be ignored. The majority of calcitonin salmon trials showed an increased risk estimate.”
Although a narrow majority voted against continued use of the drug, panelists did agree that the drug has not been shown to be effective in preventing bone fractures.
“I think the cancer risk seems to be low, but it tips the balance for this drug, which has very little evidence of efficacy,” Amy Whitaker, MD, assistant professor of obstetrics and gynecology at the University of Chicago, told Associated Press.
Health officials around the world have been reviewing the effectiveness of calcitonin salmon after two recent studies suggested a slightly higher rate of cancer among users. The European Medicines Agency recommended that the drug no longer be used to treat osteoporosis because of its cancer risk.
Some panelists, however, noted that calcitonin salmon, which is a man-made form of a hormone found in salmon, is an important option for patients who have had adverse reactions to newer drugs, including bisphosphonate drugs like Fosamax.
Caution, however, remained the focus of the panel’s recommendations. In a 20 to 1 vote, the group voted that companies developing new calcitonin salmon products must prove they are effective in reducing fractures. They also recommended that at this time the drug only be authorized for short-term use in treating Paget’s disease, for acute blood loss due to sudden immobilization, and for excess calcium in the blood caused by cancer.