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U.S. Department of Health and Human Services

Drugs

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Questions and Answers: Changes to the Indicated Population for Miacalcin (calcitonin-salmon)

 

1.       What calcitonin-salmon products are approved by the FDA for the treatment of osteoporosis?
 
A:  Calcitonin salmon products approved by the FDA to treat postmenopausal osteoporosis include Miacalcin (calcitonin salmon synthetic) injection and nasal spray (Novartis Pharmaceuticals Corporation); Fortical (calcitonin salmon recombinant) nasal spray (Upsher Smith Laboratories) and generic equivalents of Miacalcin.
 
Calcitonin-salmon products have been marketed in the U.S. since 1975.
 
2.       What prompted the FDA’s review of calcitonin-salmon containing medicines for safety and efficacy?
 
A:   Recent clinical trial findings prompted the FDA to re-evaluate the benefits and risks of calcitonin-salmon products, with a particular focus on the potential overall cancer risk, and the evidence of efficacy in postmenopausal osteoporosis. The FDA reviewed all available informative data from various sources, such as clinical trials, published literature and reported side effects regarding the risk of cancer. The FDA then held an Advisory Committee meeting on this topic (March 2013) before formulating an overall conclusion of the benefits compared to the risks of calcitonin-salmon therapy.
 
3.       What is the risk of cancer (malignancy) when using calcitonin-salmon products?
 
A:  A meta-analysis of 21 randomized, controlled clinical trials with calcitonin-salmon (nasal spray and investigational oral forms) suggests an increased risk of malignancies in calcitonin-salmon treated patients compared to placebo-treated patients.
 
The overall incidence of malignancies reported in these 21 trials was higher among calcitonin-salmon treated patients (4.1 percent) compared with placebo-treated patients (2.9 percent). The data were not sufficient for further analyses by specific type of malignancy. Although a definitive causal relationship between the calcitonin-salmon use and malignancies cannot be established from this meta-analysis, the benefits for the individual patient should be carefully evaluated against all possible risks. 
 
4.       Why is the FDA continuing to allow that these drugs be used to treat osteoporosis when EMA/CHMP and Health Canada have concluded these drugs should no longer be used to treat osteoporosis?
 
A:   The FDA’s review of these products found there is no conclusive evidence of a causal relationship between the use of these products and cancer.  We will continue to re-evaluate this issue as more information becomes available. By keeping calcitonin-salmon products on the market, FDA provides options for those patients who cannot or do not want to use other treatments for osteoporosis. We recommend that health care professionals assess a patient’s need for osteoporosis therapy, as well as the benefits and risks of available treatments.  We refer health care professionals to the prescribing information of the various products approved for the treatment of osteoporosis to be fully informed of the demonstrated benefit and risk profile of each product. 
 
5.       What should patients currently taking calcitonin-salmon containing medicines do in light of this new information? Are they safe to take?
 
A:   At this time, patients should not discontinue treatment on their own, but should discuss with their health care professional the benefits and risks of calcitonin-salmon treatment as they pertain to their individual circumstance.  As indicated in the updated labeling, calcitonin-salmon treatment should only be used in patients for whom alternative treatments are not suitable, and should be re-evaluated on a periodic basis.
 
6.       What should health care professionals do in light of this new information? Can health care professionals continue to prescribe these drugs to treat osteoporosis?
 
A:   Health care professionals should continue to assess each patient’s need for osteoporosis therapy, as well as the benefits and risks of available treatments. We refer health care professionals to the prescribing information of the various products approved for the treatment of osteoporosis to be fully informed of the demonstrated benefit and risk profile of each product.