Risks of osteoporosis drug exceed benefit, FDA panel says
Calcitonin salmon has been prescribed to strengthen bones of postmenopausal women since the 1980s.
The Associated Press
WASHINGTON — A panel of federal health experts says a long-established bone-strengthening drug should no longer be used by women because there is little evidence it works and it may increase the risk of cancer.
The Food and Drug Administration (FDA) panel voted 12-9 that the risks of the inhalable osteoporosis drug outweigh its benefits when used to treat brittle bones.
The drug, known chemically as calcitonin salmon, has been prescribed for osteoporosis in postmenopausal women since the 1980s. Novartis and Upsher-Smith now market the drug in nasal-spray form as Miacalcin and Fortical, respectively.
But 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. The drug is also available as an injection to treat other conditions, including excess calcium in the blood.
The European Medicines Agency concluded last July that calcitonin should no longer be used for osteoporosis, because of cancer risk.
An internal FDA memo released ahead of Tuesday’s meeting said it’s difficult to draw a direct link between the drug and cancer. However, “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.”
A narrow majority of panelists voted against continued use of the drug, pointing out that the drug has not been shown very effective at 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,” said Amy Whitaker, a professor at the University of Chicago.
But other panelists said the drugs are an important option for patients who have bad reactions to newer drugs, including bisphosphonate drugs like Fosamax.
“We have a whole lot of patients who can’t take the other drugs, and I think our patients would be in worse shape without this,” said Bart Clark, professor at the Mayo Clinic College of Medicine in Rochester, Minn.
Calcitonin salmon is a man-made version of a hormone found in the fish.
Prescriptions for calcitonin have plummeted in recent years amid safety concerns.
The FDA approved the drugs from Novartis and Upsher-Smith based on studies showing they increased bone-mineral density. However, no studies have definitely shown that higher density reduces bone fractures.
The FDA panel was nearly unanimous that any future calcitonin drugs should be required to show real effectiveness in preventing bone fractures. The group voted 20-1 for such a requirement.
The FDA does not have to follow the advice of its panels, though it often does.