Calcitonin Side Effects Outweight Benefits for Osteoporosis: FDA Panel

A panel of medical experts convened by the FDA has recommended that women no longer use calcitonin nasal sprays and injections for treatment of osteoporosis, because the medications are relatively ineffective and could increase the risk of cancer.

Calcitonin, often referred to as calcitonin salmon because it is a manmade version of a chemical found in salmon, has been approved in the U.S. since 1975 to treat osteoporosis, osteoarthritis and hypercalcemia. It is widely available as a generic medication and sold under the brand names Miacalcin and Fortical.

Following an FDA advisory panel meeting yesterday, a group of independent experts voted 12 to 9 in favor of recommending that the drug no longer be used to treat brittle bones, after two studies suggested that calcitonin side effects may increase the risk of cancer.

While the risk of cancer from calcitonin was small, the narrow majority of the panel decided that this new information made the dangers outweigh the minimal benefits provided for women with osteoporosis. The vote only addressed the use of calcitonin for osteoporosis.

According to FDA drug safety reviewers, concerns about the possible link between calcitonin and prostate cancer came from two clinical trials that focused on a new oral formulation of the drug. The advisory committee was convened by the FDA to review whether the cancer risks outweighed the benefits provided by the drug for treatment of osteoporosis. The vote and recommendations of the advisory committee are not binding on the FDA, but the agency generally weighs the recommendations heavily before making any final ruling.

The versions of calcitonin designed for osteoporosis treatment are Novartis’s Miacalcin, which is available in a nasal spray and injection form, and Fortical, a nasal spray by Upsher-Smith.

The panel voted 20-1 to require any future calcitonin-based drugs to show that they are effective in preventing bone fractures.