Protelos/Osseor
The preparations Protelos and Osseor (active ingredient: strontium ranelate) are approved throughout Europe for the treatment of osteoporosis in postmenopausal women to reduce the risk of spinal and hip fractures and for the treatment of osteoporosis in adult men at increased risk of fracture.
Action at the EU level The European Medicines Agency has completed its evaluation of Protelos/Osseor and recommends that its use in the future be restricted to those patients who are at high risk of fracture and who cannot be treated with other medicines that are also approved for the treatment of osteoporosis. Patients should be monitored regularly by their physician during therapy. If a patient develops cardiovascular problems during therapy, such as angina pectoris or uncontrollable high blood pressure, treatment should be discontinued. On the other hand, patients who have a history of cardiovascular problems, such as myocardial infarction or stroke, or who are currently suffering from these conditions should not receive therapy with Protelos/Osseor. The evaluation of the study data showed with regard to the efficacy of Protelos/Osseor that there is a quite beneficial effect in the prevention of fractures for patients at high risk of fracture. There are also no data to show an increased cardiovascular risk for patients without existing or previous cardiovascular problems. For this reason, Protelos/Osseor will remain available for a limited patient population. The safety of Protelos/Osseor will continue to be carefully monitored. Situation in Austria The following medicinal products are approved in Austria:
- PROTELOS 2 g granules for oral suspension.
- OSSEOR 2 g granules for the preparation of a suspension for oral use
BASG has received no reports of myocardial infarction, 1 report of heart failure, and 7 reports of thrombotic events from Austria during the period in question. BASG Recommend ations Recommendations for Users:
- Protelos/Osseor should only be used for the treatment of severe osteoporosis in postmenopausal women and in men at high risk of fracture when other drugs for osteoporosis cannot be used, e.g., due to contraindications or intolerances.
- Protelos/Osseor must not be used in patients who have a history of or currently have ischemic heart disease, peripheral arterial circulation disorders, cerebrovascular disease, or uncontrolled high blood pressure
.
- The decision to treat patients with Protelos/Osseor should be based on an individual risk assessment. The risk assessment should be performed prior to initiation of treatment, and on a regular basis, every 6 to 12 months
.
- Treatment with Protelos/Osseor should be discontinued if patients develop ischemic heart disease, peripheral arterial circulation disorders, cerebrovascular disease, or uncontrolled high blood pressure.
- It is recommended that all patients already being treated with Protelos/Osseor undergo re-evaluation and risk assessment.
Recommendations for Patients:
- Protelos/Osseor is used to treat severe bone loss in post-menopausal women and in men at high risk for fractures only if other medicines for bone loss cannot be used, for example, due to intolerance.
- Your doctor will critically assess your risk of cardiovascular disease before starting treatment and will repeat this assessment at regular intervals during the course of treatment
.
- You should not take Protelos/Osseor if you currently have or have had in the past any circulatory disorders of the heart or your arms or legs, including conditions such as strokes, heart attacks, and heart attacks
.
- If you experience any signs of cardiovascular problems during treatment, treatment with Protelos/Osseor will be stopped
.
- If you have any questions, please contact your doctor or pharmacist.
Further information: European Medicines Agency press release (02/21/2014): http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2014/02/news_detail_002031.jsp&mid=WC0b01ac058004d5c1
Patient Summary (02/21/2014):
www.basg.gv.at/news-center/patienten/arzneimittelsicherheit/
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Queries (technical): Dr. Christoph Baumgärtel, Tel: 050555/36004 Email: christoph.baumgaertel@ages.at Queries (for media): Communications Management, Tel: 050555/25000 E-mail: presse@ages.at
