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Strontium ranelate (Protos) and risk of adverse events

Safety advisory

4 February 2014

The TGA is currently undertaking a review of strontium ranelate (Protos) to assess the risk of adverse events including cardiovascular events.

Strontium ranelate is used to treat severe osteoporosis. It works by increasing bone formation and decreasing bone loss.

Information for consumers

If you, or someone you care for, is being treated with strontium ranelate and you are concerned about this issue, arrange an appointment with your medical practitioner.

More information about strontium ranelate can be found in the product's Consumer Medicine Information.

Information for health professionals

While the strontium ranelate review is underway, the TGA reminds health professionals of the current contraindications and precautions included in the Product Information (PI) for Protos and of the need to evaluate cardiovascular risk before prescribing.

In particular, health professionals are reminded of the following contraindications:

  • known hypersensitivity to strontium ranelate or to any of the excipients
  • severe renal impairment
  • current or previous venous thromboembolic events (VTE), including deep vein thrombosis and pulmonary embolism
  • temporary or permanent immobilisation (e.g. post-surgical recovery or prolonged bed rest)
  • history of ischaemic heart disease, peripheral arterial disease or cerebrovascular disease
  • systolic blood pressure greater than or equal to 160 mmHg, or diastolic blood pressure greater than or equal to 90 mmHg.

Health professionals are also reminded that the PI also includes a number of precautions, including some regarding VTE and cardiac ischaemic events.

The TGA published an article in Medicines Safety Update in August 2012, discussing strontium ranelate and the risk of VTE and serious skin hypersensitivity reactions.

For full prescribing details, health professionals should refer to the Protos PI.

Additional information

Other regulators such as the European Medicines Agency are also currently reassessing strontium ranelate's benefit-risk profile.1,2

  1. PRAC recommends suspending use of Protelos/Osseor (strontium ranelate).' European Medicines Agency 10 January 2014 (accessed 31 January 2014).
  2. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 January 2014 (accessed 31 January 2014). 'The recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) that Protelos and Osseor should no longer be used to treat osteoporosis is still under consideration by the CHMP.  At its January 2014 meeting the Committee requested additional information from the company to inform its scientific decision-making. A final opinion will be made by the CHMP at its meeting in February 2014.'

Reporting problems

Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.