FDA Panel: Long-Used Osteoporosis Drug Too Risky
By Fran Lowry
The committee voted 12-9 against continued marketing of the drug, citing lack of benefit and concerns about a cancer risk.
Calcitonin salmon has been used by women for years to treat osteoporosis.
In the U.S., calcitonin is marketed as Miacalcin and Fortical. It was approved in 1986 as an injection and in 1995 as a nasal spray. Calcitonin raises the amount of calcium in the bones while lowering calcium levels in the blood.
In 2012, the European Medicines Agency recommended that calcitonin salmon not be used to treat osteoporosis after determining that the risk of developing cancer was 2.4% higher in patients using the nasal spray than in those who took a placebo.
The nine committee members who voted to keep calcitonin on the market insisted it has a benefit, especially in the elderly and those with pain from vertebral fractures.
The 12 panelists who voted against it thought it had little benefit that might be outweighed by the cancer risk.
Cancer Risk Tips the Scale
William Cooper, MD, from Vanderbilt University School of Medicine in Nashville, Tenn., says his vote to stop marketing calcitonin salmon was swayed by the risk for cancer.
"The data that were presented to us today were not really all that compelling for benefit in the broad population of people with osteoporosis, but there is a fair amount of consistency in the data on cancer. Although it appeared to be a minor increase in risk, that really tipped the scales for me," he says.
Michael Collins, MD, from the National Institutes of Health in Bethesda, Md., also voted to stop marketing the drug.
"The cancer question, for better or for worse, has been raised. It's on the table. That weighed against limited [effectiveness] in the populations that have been studied. It's wishful thinking to say it could be effective in populations that haven't been studied, but there just aren't data to support this in my mind," he says.
Panel members who voted to keep calcitonin salmon on the market feel the cancer risk is low and that the drug could benefit specific patients.
"I think the safety concerns are there, but further data would be helpful," says Bart Clarke, MD, from the Mayo Clinic in Rochester, Minn. "I think the benefit is likely weak, but we have experience with this drug clinically, and we have a whole lot of patients who can't take the other drugs. If we take this away, a lot of our patients would be in worse shape, even acknowledging the small degree of risk that we talked about."
Kenneth Burman, MD, of Washington Hospital Center in Washington, D.C., recommends calcitonin salmon be limited to certain patients and not taken off the market completely.
"I agree that this could be [used] in patients with certain diseases, such as [kidney] failure [and] blood clots and in elderly women or other people who are unable to take the other medications for osteoporosis that are available," he says.
"As a practicing clinician, there definitely are [groups] for whom this drug is of benefit," says Richard Bockman, MD, from the Hospital for Special Surgery in New York City.
"In my own particular circumstance, these are patients with recent fractures who are basically [new to this treatment], in whom we have a definite feeling that current [alternative] therapies ... actually would interfere with healing. We like to see healing go forward, and calcitonin does not, in our hands, show any evidence for blocking healing," Bockman says.
The FDA does not have to follow the advice of its committees, but it usually does.
To see a version of this story for physicians, visit Medscape, the leading site for physicians and health care professionals.
SOURCES: William Cooper, MD, Vanderbilt University School of Medicine, Nashville, Tenn. Michael Collins, MD, National Institutes of Health, Bethesda, Md. Bart Clarke, MD, Mayo Clinic, Rochester, Minn. Kenneth Burman, MD, Washington Hospital Center, Washington, D.C. Richard Bockman, MD, Hospital for Special Surgery, New York. © 2013 WebMD, LLC. All rights reserved.
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