FDA Panel Doubts Calcitonin Salmon Osteoporosis Drug

The FDA Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee voted 12-9 on March 5, 2013, to recommend that the evidence did not support the use of calcitonin salmon nasal spray for the treatment of osteoporosis. The panel said there is little evidence they work and may actually increase the risk of cancer.

The drug has been prescribed for osteoporosis in postmenopausal women since the 1980s. According to FDA briefing documents, products approved for this indication include calcitonin salmon (Miacalcin injection and nasal spray, Novartis Pharmaceuticals), calcitonin salmon recombinant (Fortical nasal spray, Upsher Smith Laboratories) and generic equivalents.

Slightly Higher Cancer Rate

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.

Novartis reportedly conducted trial-level meta-analyses to evaluate the potential risk for malignancy in patients treated with all forms of calcitonin salmon following the prostate cancer signal noted in the osteoarthritis trials.

The results of all trials, according to data presented by FDA staff, suggest higher risk for malignancies for patients treated with calcitonin compared with patients treated with placebo (OR=1.6; 95% CI, 1.1-2.3 and risk difference=1.6%; 95% CI, (0.5- 2.8).

Malignancy evaluations demonstrated meta-analysis results consistent with an increase in the incidence of malignancies with calcitonin salmon, with similar results across statistical methods and basal cell carcinoma (BCC) being the most frequent malignancy.

An internal FDA memo released ahead of the 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.”

“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, according to an AP story.

But other panelists, according to the AP story, 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, Minnesota.

Calcitonin Salmon

Calcitonin salmon is a manmade version of a hormone found in the salmon fish. Prescriptions have plummeted in recent years amid safety concerns about the drug. Between 2006 and 2011 the number of U.S. patients receiving the drug fell 51% to 205, 000.

The FDA approved Miacalcin and Fortical based on studies showing that they increased bone mineral density. However, according to the AP, no studies have definitely shown that higher density actually reduces bone fractures. The largest study of calcitonin, which followed 1, 200 women for about five years, was plagued by logistical problems, including a high level of patients who dropped out.

The European Medicines Agency concluded last July that calcitonin should no longer be used to treat osteoporosis

The FDA panel voted 20-1 in favor of a requirement that any future calcitonin drugs should be required to show real effectiveness in preventing bone fractures.