In April 2014 the Product Information for strontium ranelate (Protos) was updated with a black-box warning1 after completion of a Therapeutic Goods Administration review.2
The review was prompted by a European Medicines Agency investigation3 and the advice contained within the warning is consistent with the European regulator’s recent recommendations.4
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.
