In briefing documents released on Friday, U.S. Food and Drug Administration (FDA) staff said that possible increased risk of cancer with drugs containing calcitonin salmon requires a reassessment of their use in the treatment of osteoporosis.
The staff reviewers said the cancer risk raises concerns about the overall risks and benefits of calcitonin products to treat osteoporosis in postmenopausal women, Reuters reports. In addition to the potential cancer risks, the reviewers also noted that significant questions remain about calcitonin salmon’s effectiveness in reducing fractures in those with 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., Reuters writes. Generic calcitonin products are also available.
On March 5, panelists at a joint meeting of the FDA’s Advisory Committee for Reproductive Health Drugs and its Drug Safety and Risk Management Advisory Committee will discuss the risks and benefits of these drugs and will advise the FDA whether it should continue to allow the products to be marketed for osteoporosis treatment, Reuters said.
Reuters reports that, last summer, European regulators recommended that long-term use of calcitonin be curtailed. A review found evidence of a small, increased risk of cancer with long-term use of the drugs. The European regulators recommended that these drugs be prescribed only for short-term use in patients with 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 in the treatment of that condition.