FDA Panel: Long-Used Osteoporosis Drug Too Risky
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.
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