News from the European Medicine Agency
A committee of the European Medicine Agency, the Europe equivalent of the US Food and Drug Administration (FDA), investigated calcitonin and cancer risk. The committee’s evaluation and recommendation for action by the agency was released July 20, 2012. Note in the US, the brand names for calcitonin used in treatment of osteoporosis are Miacalcin and Fortical.
Calcitonin has been considered safe but not that effective in treating postmenopausal osteoporosis. In fact the recent 2012 Comparative Effectiveness Review update on the treatment of low bone density and osteoporosis under the auspices of the Agency for Healthcare Research and Quality (AHRQ), calcitonin was excluded since most experts no longer consider it to be appropriate treatment for osteoporosis. Nevertheless, the drug is still prescribed in many parts of the country.
The European Medicine Agency initiated a review of calcitonin based on preliminary findings from two clinical trials using oral calcitonin (this pill formulation is not on the market) and the possible association with prostate cancer. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency reviewed randomized controlled trials conducted in patients with osteoarthritis and osteoporosis. Their analyses of these trials demonstrated an increase in the absolute risk of cancer occurrence for patients treated with calcitonin compared to placebo that varied between 0.7% and 2.4% with long-term therapy. Although based on small numbers, cancer deaths were also more frequent in patients treated with calcitonin. The concern is calcitonin treatment may promote tumor growth. Patients in these trials were treated with oral or nasal formulations of calcitonin.
The European Medicine Agency committee recommended:
- Due to the association of the increased risk of malignancies and long-term calcitonin use, the treatment duration in all indications should be limited to the shortest period of time possible and using the minimum effective dose.
- Calcitonin should no longer be used for the treatment of osteoporosis. Patients being treated for osteoporosis with calcitonin nasal sprays or other formulations are advised to speak to their doctor at a routine appointment, who will recommend suitable alternative treatment.
These recommendations are pending endorsement by the European Medicine Agency. In the US, thus far the FDA has taken no action. Stay tuned for more news.
If you are taking nasal calcitonin for osteoporosis, discuss with your doctor other possible treatments. One of the newer medicines that are more effective than calcitonin in reducing your risk of breaking a bone may be an option for you.
Source: European Medicine Agency