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March 5, 2013

Public Citizen to FDA: Nasal Calcitonin Not Effective for Osteoporosis, Linked to Increased Cancer Risk

European Regulators Announced Its Removal From The Market Last Year; FDA Should Follow Suit

WASHINGTON, D.C. – Calcitonin nasal spray, prescribed to treat osteoporosis since 1994, should be removed from the market because it is not very effective and may cause cancer, Public Citizen told the U.S. Food and Drug Administration (FDA) today.

Testifying before the FDA’s Advisory Committees on Reproductive Health Drugs and Drug Safety and Risk Management, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, urged the FDA to follow the lead of the European Medicines Agency (EMA) and take prompt action to remove nasal calcitonin from the U.S. market. The EMA found in July 2012 that there was a small increased risk of cancer associated with calcitonin and concluded that the risks associated with the drug outweighed its benefits.

Since the EMA’s announcement, 125,000 women in the U.S. have been prescribed nasal calcitonin. The drug, made by Novartis (as Miacalcin) and generic manufacturers, also is associated with serious allergic reactions, such as swelling of the tongue or throat and anaphylactic shock that can be fatal.

"Unless the FDA believes that calcitonin nasal spray is somehow more effective and less likely to cause cancer in people in this country than in Europeans, the agency must immediately begin the process of removing it from the U.S. market before tens of thousands of additional women are subjected to its risks,” Wolfe said.

One study of the effectiveness of the drug in reducing fractures was plagued with enrollment and other difficulties. During another study, a large number of patients dropped out, leading the FDA to question the reliability of the results.

In its December 1995 issue of its “Worst Pills, Best Pills News,” Public Citizen listed calcitonin nasal spray as a “do not use” drug because of the lack of evidence that it is effective for preventing fractures.

The EMA recommends that calcitonin not be available as a nasal spray but only as an injectable drug, and only for prevention of acute bone loss due to sudden immobilization. In addition, the injectable form should be used only for two to four weeks.

To read Wolfe’s testimony, visit http://www.citizen.org/hrg2101.


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