March 12, 2013
FDA’s Risk Management Advisory Committee, Reproductive Health Drugs, and Drug Safety Committee meeting jointly determined that the benefits of calcitonin salmon did not outweigh the risks associated with long term use for osteoporosis. They reported that there is little evidence of efficacy and it may increase risk of cancers, including melanoma. The advisory panel voted 12-9 that calcitonin salmon nasal spray (eg, Miacalcin®, Fortical®) should no longer be used to treat osteoporosis in post-menopausal women. The FDA advisory panel also voted 20-1 that all companies who are developing new versions of calcitonin salmon hormone must provide clinical efficacy data showing that their product reduces fracture risk. FDA has not yet made a decision regarding the recommendations of the advisory panel.
Calcitonin salmon is a synthetic version of calcitonin hormone found in salmon. Calcitonin salmon is also available as an injectable, and is used to treat Paget’s disease, hypercalcemia, and postmenopausal osteoporosis. Calcitonin salmon is more potent than human calcitonin and has a longer duration of action.
Additional information is available at the following links:
- ASHP Daily Briefing:
- Medpage Today:
March 12, 2013; University of Utah, Drug information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.