In background documents released on Friday, U.S. Food and Drug Administration (FDA) staff said that the potential increased risk of cancer with drugs containing calcitonin salmon requires a reassessment of the use of these drugs to treat osteoporosis in postmenopausal women.
The reviewers said the cancer risk raises concerns about the overall risks versus benefits of calcitonin products to treat osteoporosis in postmenopausal women, Reuters reports. The reviewers said significant questions remain about calcitonin salmon’s effectiveness in reducing fractures in the treatment of postmenopausal osteoporosis.
Calcitonin salmon is a man-made version of the hormone calcitonin found in salmon. Calcitonin products include Novartis AG’s Miacalcin injection and nasal spray and Unigene Laboratories Inc.’s nasal spray, which is distributed in the United States by Upsher Laboratories Inc. Generic calcitonin products are also available.
At a March 5 joint meeting, the FDA’s Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee will discuss the products and will make a recommendation to the FDA on whether to allow the continued marketing of these drugs for use in osteoporosis treatment, Reuters said.
Reuters reports that, last July, European regulators recommended that long-term use of calcitonin be curtailed after a review found evidence of a small increased risk of cancer with long-term use of the drugs. They recommended limited uses for calcitonin-containing drugs, including short-term use in Paget’s disease, a bone disorder; for acute bone loss due to sudden immobilization; and for excess calcium in the blood caused by cancer. The European regulators ruled that the benefits of these medicines did not outweigh their risks in the treatment of osteoporosis and that they should no longer be used for this condition.
Novartis, in a statement reported by Reuters, said that it “places the highest priority on patient safety and the appropriate use of its medicines and is looking forward to the opportunity to engage in the discussion at the upcoming meeting.”