Black-box warning for strontium ranelate (Protos) added to Product Information

NOTE: Strontium ranelate deleted from the PBS from 1 August 2016. [Details]

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.