Field of application
Calcitonin is still used today in patients suffering from Paget’s disease (a disease of the skeletal system with increased and disorganized bone remodeling) who do not respond to other treatment options or for whom treatment alternatives are not suitable. One reason why other treatment would not be appropriate would be, for example, severe renal dysfunction. In this case, treatment with Calcitonin should only be carried out for three months.
In addition, Calcitonin has also proven to be effective in cases of hypercalcemia, i.e. too high a concentration of calcium ions, as a result of a malignant disease. Finally, Calcitonin may also be administered to prevent further loss of bone mass in patients who have experienced sudden immobilization (temporary immobilization of parts of the body or the entire body) due to a bone fracture. In this case the treatment should only be carried out for a maximum of two to four weeks.
As there have been indications in studies that the therapeutic use of Calcitonin increases the risk of malignant disease, a Calcitonin nasal spray should no longer be used for the treatment of postmenopausal osteoporosis, as the risk outweighs the benefit of the treatment (unfavourable benefit-risk ratio). If treatment with such a preparation is carried out when “postmenopausal osteoporosis” is diagnosed, it should be changed at the next visit to the doctor. Due to this fact the Calcitonin nasal spray has been taken off the market.
From now on, Calcitonin will only be available in the form of infusion and injection solutions. Calcitonin will continue to be used for the above-mentioned diseases, as studies have shown that the benefits of short-term treatment outweigh the risks. Despite this, the lowest possible dose should be chosen and the treatment period should be kept as short as possible.
Adverse drug reactions
The most frequent side effect of the administration of Calcitonin is a sudden reddening of the face. This is also known as “flush”. Other frequently occurring adverse drug reactions are a tingling sensation or a feeling of warmth in the extremities.
Nausea, vomiting and diarrhoea can force a discontinuation of therapy. Hives (urticaria) with wheals on the skin can also occur as an adverse drug reaction. The effect of the therapeutic use of Calcitonin decreases over the course of a longer therapy. Furthermore, long-term therapy with Calcitonin increases the risk of cancer.
Risk of cancer in long-term use
The European Medicines Agency (EMA) warns against the long-term use of the Calcitonin nasal spray in postmenopausal osteoporosis, as it has limited efficacy while apparently increasing the risk of cancer by up to 2.4% compared to placebo (sham drug without a drug). As a result, it was decided to withdraw the intranasal preparations (nasal spray) from the market in 2012. Karil® and Miacalcic® were withdrawn from the market.
In 2004, an application was made for the control of these preparations, as two studies had shown that an oral preparation, which was not even approved, had increased the risk of prostate cancer. Meanwhile it could be shown in subsequent studies that not only the permanent use of the oral preparation increases the risk of prostate carcinoma, but also the nasal sprays. This not only increases the risk of prostate cancer, but also of other malignant diseases. However, preparations for administration into the vein will remain on the market, as the risk-benefit ratio is more favourable.
