Studies show that there has been an increased risk of cancer associated with the long-term use of intra-nasal calcitonin sprays (the only formulation of calcitonin licensed for osteoporosis). The European Committee on Medicinal Products for Human Use (CHMP) has, therefore, recommended that the intra-nasal calcitonin sprays be withdrawn from the European pharmaceutical market.
What is Calcitonin?
- Calcitonin is a naturally occurring hormone in the human body.
- It helps with regulating calcium levels, and is involved in the bone-building process.
- It is usually taken by shot or nasal spray by women with osteoporosis to help reduce bone loss by slowing down the rate of bone thinning.
- It also relieves pain for spinal compression fracture – when bones in the spine (vertebrae) break and collapse on top of each other.
- Calcitonin can also be used for men with osteoporosis and who have normal levels of testosterone, or whose osteoporosis does not get better with testosterone treatment.
Why is Calcitonin Dangerous?
- The data on the risks and benefits of calcitonin have been reviewed. This includes data from randomized clinical trials with intra-nasal and unlicensed oral calcitonin formulations.
- In such trials, there were occurrences of different types of malignancies, which were observed more frequently in patients treated with calcitonin, compared with a placebo.
- The studies revealed an absolute increased risk of cancer that varied between 0.7% and 2.4%.
- The review concluded that because the increased risk of cancer associated with the long-term use of calcitonin, the benefits no longer outweigh its risks in treating osteoporosis.
Intra-nasal Calcitonin Sprays Have NOT Been Withdrawn in the U.S.
There are two intra-nasal calcitonin sprays in the U.S. currently. One is called Miacalcin, which is developed by Novartis and generic manufacturers, and the second is developed by Upsher-Smith/Unigene and is still under patent. These brands of intra-nasal calcitonin sprays are available in the U.S., and the FDA has not withdrawn these sprays – which have been shown to increase the likelihood of cancer with long-term use. However, the reported increased risk of cancer is not shown to be one of the side-effects of calcitonin on WebMD’s website or on the drug labels.
Canada has acknowledge Europe’s decision to remove the intra-nasal calcitonin spray from its market, and is currently assessing the situation and trying to figure out whether or not to follow suit.
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