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FDA Weighs Cancer Risks with Salmon-Hormone Calcitonin Drugs

Mar 4, 2013

Federal health officials are meeting this week to determine the future of a salmon hormone drug that’s used to treat bone loss in post-menopausal women because they pose a cancer risk to those taking them.

According to a recent Bloomberg report, a Food and Drug Administration advisory panel is convening this week and debating the future of oral, injectable, and nasal calcitonin-salmon formulations. These pharmaceuticals are sold by several different companies in the U.S. Calcitonin is a hormone derived from salmon and is used to produce calcium in the bones while reducing it in the blood.

The FDA panel will meet this week and make its recommendation to the agency, which can or can not choose to take its advice. The panel will be determining whether the risk of cancer while taking cacitonin-salmon hormone drugs outweighs the benefits to a woman’s bone health. Last year, the European Medicines Agency made the recommendation to halt sales of these drugs to women.

In a statement from the FDA panel released to Bloomberg, it said, “This lack of effectiveness when combined with the potential for a cancer risk associated with calcitonin salmon therapy raises concerns about the overall risk and benefit assessment.”

Though several companies actively market calcitonin drugs, Novartis’ Miacalcin is the leading seller in the U.S. Last year, about 28,000 prescriptions for the drug were written in the U.S. and that figure is just more than half the amount sold in 2011, based on Bloomberg’s assessment. Miacalcin was approved as an injectable drug in 1986 in the U.S. A decade later, in 1995, it was approved as a nasal spray.

The EMA used data which examined the cancer risks associated with using an injectable or nasal solution of calcitonin found that women using the nasal spray version faced a 2.4 percent higher risk of developing cancer compared to women taking a placebo drug. Women who took the oral drug faced a seven-tenths percent higher risk of cancer than those taking the placebo drug.

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