Strontium ranelate (Protos) and risk of adverse events

Consumers and health professionals are advised that Servier Laboratories (Australia) has updated the Product Information (PI) - external site for strontium ranelate (Protos) after the completion of a TGA review. The updates to the PI - external site, 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 - external site to highlight the updated information.

The black box warning states:

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

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

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 - external site.

Information for health professionals

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

• 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 - external site.

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 - external site (CHMP) 17-20 February 2014 (accessed 26 March 2014).
2. European Medicines Agency recommends that strontium ranelate remain available but with further restrictions - external site. "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.