Strontium ranelate (Protos) and risk of adverse events

Safety advisory

3 April 2014

Consumers and health professionals are advised that Servier Laboratories (Australia) has updated the Product Information (PI) for strontium ranelate (Protos) after the completion of a TGA review. The updates to the PI, made in consultation with the TGA, emphasise the contraindications, reinforce precautions, highlight the need for regular monitoring and update data relating to the risk of adverse events.

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

A black box warning has been added to the PI to highlight the updated information.

The black box warning states:

Protos should only be used when other medications for the treatment for osteoporosis are considered unsuitable. Protos 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. It should also not be used in patients who are temporarily or permanently immobilised. Protos should be used with caution in patients with risk factors for cardiovascular events or venous thrombosis: hypertension, diabetes, smoking, hyperlipidaemia. All patients prescribed Protos should be fully informed of the risk of cardiovascular events and venous thrombosis. Patients should be regularly monitored, every 6 months.

Other sections of the PI have been updated to highlight these issues.

The Consumer Medicines Information (CMI) is also being updated to reflect the changes to the PI.

Information for consumers

If you, or someone you care for, is being treated with strontium ranelate (Protos) and you are concerned about the issues discussed above, arrange an appointment with your general practitioner.

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

Information for health professionals

Health professionals are reminded of the following important information in the PI:

  • Strontium ranelate (Protos) should only be used when other medications for the treatment for osteoporosis are considered unsuitable.
  • Strontium ranelate (Protos) must not be used in patients who are temporarily or permanently immobilised or who have an established, current or past history of:
    • ischaemic heart disease
    • peripheral vascular disease
    • cerebrovascular disease
    • uncontrolled hypertension
    • venous thromboembolism
    • pulmonary embolism.
  • Use strontium ranelate (Protos) with caution in patients with significant risk factors for cardiovascular events or venous thrombosis: hypertension, diabetes, smoking, or hyperlipidaemia.
  • All patients prescribed strontium ranelate (Protos) should be monitored every 6 months and fully informed of this as well as being advised on the risk of cardiovascular events and venous thrombosis.

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 examining strontium ranelate's benefit-risk profile.1,2

  1. The Committee for Medicinal Products for Human Use (CHMP) "concluded its review of [strontium ranelate] at its February meeting and has recommended further restricting the use of the medicine to patients who cannot be treated with other medicines approved for osteoporosis". Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 February 2014 (accessed 26 March 2014).
  2. European Medicines Agency recommends that strontium ranelate remain available but with further restrictions. "In addition these patients should continue to be evaluated regularly by their doctor and treatment should be stopped if patients develop heart or circulatory problems, such as uncontrolled high blood pressure or angina. As recommended in a previous review, patients who have a history of certain heart or circulatory problems, such as stroke and heart attack, must not use the medicine." (accessed 26 March 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.