×

EMA recommends further restrictions on the use of the osteoporosis medicine strontium ranelate (Protelos®)

25 February 2014

The European Medicines Agency (EMA) recommends to restrict the use of the osteoporosis medicine strontium ranelate (Protelos®) to patients with severe osteoporosis who cannot be treated with other medicines approved for osteoporosis.

Doctors should pay attention to the new restricted indication and the updated special warnings and precautions for use. Patients should contact their doctor if they have any questions regarding treatment with strontium ranelate.

Information to doctors

Doctors should evaluate the patients' risk of developing cardiovascular disease and other risk factors before starting treatment and on a regular basis thereafter. In addition, treatment with strontium ranelate should be stopped if the patient develops:

  • Ischaemic heart disease
  • Peripheral arterial disease
  • Cerebrovascular disease
  • Uncontrolled hypertension

Doctors should review their patients currently on strontium ranelate to determine whether to continue the treatment.

Doctors prescribing osteoporosis medicine will receive a letter and education material from the company about the changed recommendations.

Background

In April 2013, the use of strontium ranelate (in Denmark marketed under the trade name Protelos®) was limited to patients with severe osteoporosis and at high risk of fracture. The restriction was due to the risk of heart-related adverse reactions.

EMA has now completed its review of the benefits and risks of the treatment and concluded that strontium ranelate should remain available in Europe. But the medicine should only be used to treat patients with severe osteoporosis who cannot be treated with other medicines approved for osteoporosis, e.g. due to contraindications or intolerance.

For more information, please see EMA's press release: European Medicines Agency recommends that Protelos/Osseor remain available but with further