Strontium ranelate (Protelos): restricted indications, new contraindications, and warnings due to risk of serious cardiac disorders
An EU review co-ordinated by the European Medicines Agency (EMA) of available safety data for strontium ranelate (Protelos) has raised concern about its cardiovascular safety beyond the already recognised risk of venous thromboembolism, with no observed risk in mortality1,2. An analysis of randomised controlled trial data from studies in approximately 7,500 post-menopausal women with osteoporosis has identified an increased risk of serious cardiac disorders, including myocardial infarction (1.7% versus 1.1 % with placebo, with a relative risk of 1.6 (95% CI = [1.07; 2.38])). Furthermore, there was also an imbalance of serious cardiac events, both in a study in osteoporotic men, and in a study in osteoarthritis.
A full evaluation of the benefits and risks of strontium ranelate will be undertaken at EU level over the coming months and pending any further recommendations to help minimise the risk of serious cardiac events, the following advice should be followed:
Advice for healthcare professionals:
- Use of strontium ranelate is now restricted to treatment of severe osteoporosis:
- in post-menopausal women at high risk of fracture.
- in men at increased risk of fracture.
- Treatment with strontium ranelate should only be initiated by a physician with experience in the treatment of osteoporosis, and the decision to prescribe strontium ranelate should be based on an assessment of the individual patient’s overall risks.
- Strontium ranelate is contraindicated in patients with ischaemic heart disease, peripheral arterial disease or cerebrovascular disease; a history of these conditions or in patients with uncontrolled hypertension.
- Prescribers are advised to assess the patient’s risk of developing cardiovascular disease before starting treatment and thereafter at regular intervals. Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with strontium ranelate after careful consideration of the benefit-risk balance of such treatment.
- Treatment with strontium ranelate should be discontinued if the patient develops ischaemic heart disease, peripheral arterial disease or cerebrovascular disease or if hypertension becomes uncontrolled.
- Healthcare professionals should review patients at a routine appointment and consider whether or not to continue treatment.
This information has been highlighted on the IMB and EMA websites3 and through distribution of a letter from the Marketing Authorisation Holder to healthcare professionals. Further updates will be provided when the current evaluation has been completed.
Key Message
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References:
1- 48th edition of the IMB DSN. Available at: http://www.imb.ie/images/uploaded/documents/Drug%20Safety%20Newsletter%20(Website)%2048%20final%20version.pdf
2- Strontium updates on risks of VTE and skin reactions. MIMS Ireland June 2012. Available at: http://www.imt.ie/mims/2012/06/strontium-and-risks-of-venous-thromboembolism-and-severe-allergic-skin-reactions.html
3- Recommendation to restrict the use of Protelos/Osseor (strontium ranelate). EMA. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/04/WC500142507.pdf