Calcitonin Osteoporosis Drug May Increase Risk of Cancer: FDA Staff
Federal drug regulators indicate there may be a slight increase in the risk of cancer from calcitonin, an osteoporosis drugs that is sold under the brand names Fortical and Miacalcin.
According to a briefing report (PDF) released by the FDA in preparation for an advisory committee meeting scheduled for this week, staff reviewers said that it is possible users may face an increased cancer risk from side effects of calcitonin drugs.
The materials were provided as background for a joint meeting of the FDA’s Reproductive Health Drugs and Drug Safety and Risk Management advisory committees, which will take place on March 5.
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The advisory committee has been convened by the FDA to review whether the cancer risks outweigh the benefits provided by the drug for treatment of osteoporosis. While any recommendations made by the panels are not binding on the FDA, they often factor heavily in any regulatory actions.
According to FDA drug safety reviewers, a possible link between calcitonin and prostate cancer came from two clinical trials that focused on a new oral formulation of the drug. Out of 776 men tested in the first trial, six who received the drug were later diagnosed with prostate cancer. None of the men who were given a placebo developed prostate cancer.
A follow-up on the men involved in the study found that 17% of those who took calcitonin had elevated levels of Prostate-specific antigens (PSAs), which is usually associated with the presence of prostate cancer and other prostate problems. Additional screening found a total of 20 men who were given calcitonin during the clinical trials had developed prostate cancer, but also found 16 men who were given the placebo who had prostate cancer as well.
Researchers determined that 5.4% of the men given calcitonin had developed prostate cancer, compared to only 4% of men given the placebo, leading the FDA staff members to indicate that the risk may be worth noting, although it does not currently appear to be of great concern.
Calcitonin has been approved in the U.S. since 1975. It is used to treat osteoporosis, osteoarthritis and hypercalcemia. It is available in nasal spray and injection form under the brand name Miacalcin, and as a nasal spray called Fortical. It is also available in generic form.
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