Dear Healthcare Professionals Letter on new restrictions of the indication and recommendations for monitoring of Osseor/Protelos (strontium ranelate) use
Servier Pharma d.o.o. has, in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA) sent out a letter on new restrictions in the indication and recommendations for monitoring of Osseor/Protelos use of EMA’s review of risks and benefits of strontium ranelate. Available data do not demonstrate an increased cardiovascular risk in patients without contraindications for use included in April 2013.
- From now on the use of Osseor/Protelos is restricted for treatment of severe osteoporosis:
- in post-menopausal women and
- in adult men with severe osteoporosis who have a high risk of fracture and cannot be treated with other medicines approved for osteoporosis, due to, for example, contraindications and intolerance. In post-menopausal women, strontium ranelate decreases the risk of spinal and hips fractures.
- Current cardiovascular contraindications remain in effect. Patients with proved, existing or previous ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease or uncontrolled hypertension should not be treated with Osseor/Protelos.
- Prescribers are advised to:
- estimate the risk in patients for development of cardiovascular disease before beginning the treatment, generally every 6-12 months,
- interrupt the treatment if the patient develops ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or if the hypertension is uncontrolled.
- The treatment may be initiated by a physician experienced in treating osteoporosis.
- For healthcare professionals and patients educational material related to the current indication and restrictions of Osseor/Protelos use will be prepared.
The EMA has initiated a review after the cardiovascular safety issue has been raised.
Strontium ranelate is associated with an increased risk of cardiovascular disorders, including heart attack. This conclusion is predominantly based on combined data from placebo controlled clinical trials in post-menopausal women with osteoporosis (3.803 women treated with strontium ranelate which corresponds 11.270 patient-year of treatment and 3.769 women receiving placebo, which corresponds to 11.250 patient-year of treatment). In this data set a significant increase of myocardial infarction in patients treated with strontium ranelate has been noted as to those receiving placebo (1,7% vs 1,1% with relative risk 1,6 (95% CI [1,07-2,38]). Also, there has been an increased risk of venous thromboembolism and embolic events as compared to placebo (1,9% vs 1,3%) with relative risk 1,5 (95% CI = [1,04-2,19]).
However, available data do not indicate a cardiovascular risk in patients without contraindications (established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease or uncontrolled hypertension).
Regarding the benefits, the efficacy data showed an effect in preventing fractures, including in patients at high risk of fracture.
Here you may view the dear Healthcare Professional Letter.
HALMED has by now received three cardiovascular adverse reaction reports to strontium ranelate. Two reports have been considered serious and have been referring to fibrillation of atrium and supraventricular extra-systole. The third report referring to uncontrolled blood pressure and palpitation, has not been considered serious. In all three cases the adverse reactions occurred in women and in the moment of reporting the patients were recovered or were in the course of recovering. HALMED will continue monitoring the safe use of strontium ranelate and will inform the public promptly about any new findings.
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.