FDA panel looks askance at calcitonin bone drugs
New restrictions may be in store for a long-used set of bone-building drugs. Worried about a possible increase in cancer risk--and unconvinced of the drugs' benefits--an FDA advisory panel voted against using calcitonin salmon products in osteoporosis patients.
The data indicating an increased risk of cancer isn't conclusive, FDA reviewers told the committee. But "the potential for a cancer risk ... cannot be ignored. The majority of all calcitonin salmon trials showed an increased risk estimate."
What's more, the drug hasn't shown to be very effective at preventing fractures, panelists said. "I think the cancer risk seems to be low, but it tips the balance for this drug, which has very little evidence of efficacy," said Amy Whitaker, a professor at the University of Chicago (as quoted by Dow Jones).
In the end, the panel voted 12 to 9 that the risks of the drugs outweigh their benefits in women with osteoporosis. The drugs--which include Novartis' ($NVS) Miacalcin and Unigene Laboratories' Fortical, as well as generics--are also approved for use in patients with Paget's disease and cancer, and for acute bone loss because of sudden immobilization.
Use of the drug has dropped off substantially in recent years because of safety concerns, Dow Jones noted; between 2006 and 2011, the number of patients using it dropped by 51% to 205,000. FDA officials will review the panel's recommendations and issue its final decision.
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