Does calcitonin-salmon (Fortical, Miacalcin) increase the risk of malignancy in patients with osteoporosis?

Updated: Sep 26, 2019
  • Author: Monique Bethel, MD; Chief Editor: Herbert S Diamond, MD  more...
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Answer

In 2013, an FDA post-marketing review was prompted after studies showed increased risk of malignancies in calcitonin-treated patients. In a meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray or investigational oral formulations), the incidence of malignances in calcitonin-treated patients was 4.1%, versus 2.9% in placebo-treated patients. The data were not sufficient for further analysis by specific malignancies and a definitive causal relationship between calcitonin use and malignancies could not be established. The FDA has recommended that health care professionals assess a patient’s need for osteoporosis therapy as well as benefits and risk of available treatments. [184]


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