Strontium Ranelate (Protelos/Osseor) Restrictions Recommended in EU

Deborah Flapan


April 12, 2013

(Updated April 26, 2013) The European Medicines Agency has confirmed the recommendation to restrict the use of strontium ranelate (Protelos/Osseor, Servier) because of concerns about the risk for adverse cardiac events with the product. The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended the restrictions earlier this month, and the Committee for Medicinal Products for Human Use (CHMP) has now endorsed this.

Strontium ranelate has been approved in Europe since 2004 for the treatment of osteoporosis to reduce the risk for vertebral and hip fractures in postmenopausal women. In 2012 the indication was expanded to include men at increased risk for fracture. It is not currently approved in the United States.

In a routine benefit/risk assessment of trials involving about 7500 patients, the PRAC found an increased risk for adverse cardiac events, including myocardial infarction (MI), in women receiving strontium ranelate compared with those who received placebo. However, there was no increased risk for death. There was also an imbalance in the number of serious cardiac events seen with the medicine in 2 other studies, one in men with osteoporosis and the other in patients with osteoarthritis, the CHMP said.

This more in-depth risk evaluation was undertaken due to earlier concerns about other serious adverse events such as venous thromboembolism and rare but serious skin reactions with strontium ranelate.

The following restrictions apply, the CHMP said today:

  • Strontium ranelate should only be used for the treatment of severe osteoporosis in postmenopausal women at high risk for fracture and severe osteoporosis in men at increased risk for fracture.

  • Strontium ranelate should not be used in patients with current or past history of ischemic heart disease (such as angina or MI), peripheral arterial disease, or cerebrovascular disease or in patients with uncontrolled hypertension.

  • Physicians should base their decision to prescribe Protelos/Osseor on an assessment of the individual patient's risks. The patient's risk of developing cardiovascular disease should be evaluated before and at regular intervals during treatment.

The CHMP opinion will be sent to the European Commission, the executive branch of the European Union, which will issue a legally binding decision,