In addition to the black-box warning, data on the risk of adverse events has also been amended within the Product Information.2
However, there is no change to the current Authority Required PBS listing for strontium ranelate, which remains a treatment for severe established osteoporosis for patients who meet appropriate clinical criteria.5
Prescribers are encouraged to evaluate patients for cardiovascular risk before starting strontium ranelate.1 Advise patients of the risk of cardiovascular events and venous thrombosis associated with strontium ranelate, and of the need for 6-monthly monitoring.1
The black-box warning1 advises that strontium ranelate:
- should only be used when other osteoporosis medicines are considered unsuitable
- is contraindicated and must not be used in patients with established, current or past history of:
- ischaemic heart disease
- peripheral vascular disease
- cerebrovascular disease
- uncontrolled hypertension
- venous thromboembolism
- pulmonary embolism.
- should not be used in patients who are temporarily or permanently immobilised
- should be used with caution in patients with risk factors for cardiovascular events or venous thrombosis: hypertension, diabetes, smoking, hyperlipidaemia.
- Servier Laboratories (Australia) Pty Ltd. Protos (strontium ranelate) Product Information (Updated 21 March 2014). 2014. [Online] (accessed 3 April 2014).
- Therapeutic Goods Administration. Strontium ranelate (Protos) and risk of adverse events: Safety advisory 3 April 2014. [Online] (accessed 15 October 2014).
- European Medicines Agency. PRAC recommends suspending use of Protelos/Osseor (strontium ranelate). 2014. [Online] (accessed 15 October 2014).
- European Medicines Agency. European Medicines Agency recommends that Protelos/Osseor remain available but with further restrictions. 2014. [Online] (accessed 15 October 2014).
- PBS. M05B – Drugs affecting bone structure and mineralization Commonwealth of Australia, 2014. [Online] (accessed 15 October 2014).