Medicinal Products

Dear Health Care Professional Letter about the recall of medicinal products Miacalcic 200 IU nasal spray, solution and Miacalcic 100 IU/ml solution for injection and infusion (calcitonin) from the Croatian market

08.03.2013

Novartis Hrvatska d.o.o., the marketing authorisation holder for medicinal products Miacalcic 200 IU nasal spray, solution and Miacalcic 100 IU/ml solution for injection and infusion (calcitonin), has i n collaboration with the Agency for Medicinal Products and Medical Devicesd (HALMED) sent out a letter to health care professionals about the new information associated with the use of calcitonin. Due to a risk of malignant diseases with a long term use of the product, Miacalcic 200 IU nasal spray, solution has been withdrawn from the market, whereas Miacalcic 100 IU/ml solution for injection has been withdrawn from commercial reasons.

The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency completed recently the revision of benefits and risks for calcitonin and concluded that from randomised controlled clinical studies there was an evidence of an increased risk of malignant diseases associated with a long term use of calcitonin as compared to placebo. Taking into account an increased risk of malignant diseases with a long term use, the CHMP concluded that calcitonin risks overweigh the benefits for treatment of postmenopausal osteoporosis. Due to the afore mentioned it is concluded that for safety reasons marketing authorisations for calcitonin-containing nasal sprays indicated for postmenopausal osteoporosis treatment should be suspended for, hence their benefits risks ratio is negative. For those calcitonin-containing products in the form of injections or infusions, benefits risks ratio remains positive for a short term treatment of Paget’s disease in patients that do not respond to alternative treatments or such a treatment is not appropriate for them, for prevention of acute bone loss due to sudden immobilisation, and the treatment of hypercalceamia caused by cancer.

Information about the regulatory status of calcitonin-containing medicinal products in the Republic of Croatia

Two calcitonin-containing medicinal products, Miacalcic 200 IU nasal spray, solution and Miacalcic 100 IU/ml solution for injection and infusion of the marketing authorisation holder, Novartis Hrvatska d.o.o. have been authorised in the Republic of Croatia. Both marketing authorisations were revoked on 5 March 2013: the marketing authorisation for Miacalcic 200 IU nasal spray, solution is revoked for safety reasons, wheras Miacalcic 100 IU/ml solution for injection and infusion is revoked for commercial reasons. The above mentioned medicinal products are being withdrawn from the market, whereby the withdrawal of the nasal spray will be executed in the soonest time during March 2013.

The utilisation of the aforementioned products in the Republic of Croatia has been relatively low and amounts for the solution for infusion 0.00009548 DDD/1000/day, whereas for the nasal spray amounts 0.00571987 DDD/1000/day.

Recommendations for health care professionals

• Calcitonin should no longer be used for the treatment of postmenopausal osteoporosis, because risks associated with calcitonin outweigh benefits for this indication. To atients treated with calcitonin against osteoporosis, a suitable alternative treatment should be prescribed during the next planned (or routine) examination.
• Benefits of calcitonin still outweigh the risks in short term treatments:
• • Paget’s disease in patients who do not respond to alternative treatments, i.e. patients with severe renal impairment. The treatment of this indication should be limited in most cases to 3 months. Under exceptional circumstances - i.e., in patients with potential pathological fractures, the treatment may be extended to 6 months. Repeatedly (occasionally) the treatment may be considered taking into account the benefits and risks.
  • For preventing acute bone loss due to sudden immobilisation, as in the case in patients with recent osteoporotic fractures, with the treatment limited to four months.
  • Hypercalcaemia in cancer.
• Due to an increased risk of cancer, the duration of calcitonin treatment should be limited to the shortest possible time using the smallest effective dose.

Recommendations for patients

Patients being treated with calcitonin-containing medicinal products are advised to speak to their doctor who has prescribed the medicine at a planned (or routine) appointment about the continuation of their therapy.

If worried, patients are advised to talk to their doctor.

Here you may view the Dear Health Care Professional Letter (in Croatian).

Until now, HALMED has not received any adverse reaction report to calcitonin-containing medicinal products.

We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.