Important safety information on benefits and risks of calcitonin containing medicinal products
The European Medicines Agency recommends a limited long-term use of calcitonin-containing medicines, which means suspension of intranasal formulations for the treatment of osteoporosis and new limited indications for for formulations that are used as injections or infusions for the treatment of Paget's disease. Untill the decision of the status of those medicines on the Croatian market, for which, according to the rules of the EU, a decision of the European Commission is needed, The Agency for Medicinal Products and Medical Devices (HALMED) brings recommendations for prescribers on the use of calcitonin-containing medicines.
The Agency's Committee for Medicinal Products for Human Use (CHMP)recommended that calcitonin-containing medicines should only be authorised for a short-term use due to evidences that a long-term use is associated with an increased risk of cancer.
Recommendations for prescribers:
1. Doctors may no longer prescribe intranasal formulations of calcitonin-containining medicines for the treatment of osteoporosis.
2. Calcitonin will only be available as a solution for injections or infusions and may be used only for :
- prevention of acute bone loss due to sudden immobilisation: the recommended treatment duration is two weeks and the maximal duration is four weeks,
- treatment of Paget's disease in patients that do not react on other treatments or for whom other treatments are not appropriate, with a treatment duration, normally limited to three months,
- treatment of hypercalcaemia caused by cancer.
3. The calcitonin treatment should be limited to a shortest period of time and to the smallest most effective dose
The analysis of all the available clinical studies of calcitonin shows and increased risk of cancer. In the long-term clinical trials the risk of cancer was 0.7 to 2.4 % higher than in patients who received calcitonin-containing medicines with respect to patients taking placebo, whereas the highest rates were in trials with intranasal formulations of calcitonin.
Bearing in mind the limited efficacy of calcitonin in the treatment of postmenopausal osteoporoses in order to dicrease the risk of vertebral fractures, CHMP concluded that benefits of calcitonin-containing medicines did not outweigh the risks in this indication. In respect that the nasal spray is used in the treatment of osteoporoses only , CHMP recommended that the aforementioned formulation be withdrawn from the EU coutries.
For all other authorised indications, CHMP concluded that the benefits risks ratio remained positive, but recommended the minimal duration of calcitonin treatment. For the treatment of Paget's disease, CHMP recommends a limited application of calcitonin, which would be used as a second line therapy in patients not reacting to to other treatments or or in patients in which other treatments are not appropriate. The duration of the treatment of Paget's disease, should normally be limited to three months. However, in exceptional cases it may be extended to six months and it may be repeated with interruptions, if estimated that potential benefits outweigh risks.
The CHMP opinion has been forwarded to the European Commission, who will make a decision for the EU countries. In the Republic of Croatia, two calcitonin-containing medicines have been authorised; one as a nasal spray, whereas other medicine is a solution for injections and infusions. In order to make a decision on the status of these medicines in Croatia, HALMED, according to EU regulations awaits a Commission's decision.
As soon as the decision on the calcitonin-containing medicines has been taken, HALMED will inform tha public in due course.
HALMED has not untill now received any ADR report to calcitonin-containing ,edicines. HALMED will continue to monitor the safety of the calcitonin use and will infor the public in due course about every new information.
We remind that health care professionals are required to report to HALMED every ADR. Patients who have developed any adverse reaction may also report it directly to HALMED with a recommendation to consult with their doctor or pharmacist for every adverse reaction they observe.