Protelos: EMA recommends further restrictions for use

1 April 2014

The use of Protelos (strontium ranelate) for the treatment of severe osteoporosis in postmenopausal women and men at high risk of fracture should be limited to patients with no history of cardiovascular disease who are unsuitable for treatment with other osteoporosis medicines, according to new advice from the European Medicines Agency (EMA).

Protelos (strontium ranelate) should only be used in patients with severe osteoporosis provided that they have no significant cardiac risk factors and only when other treatments are unsuitable | SCIENCE PHOTO LIBRARY

In January 2014 the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) recommended that the licence for Protelos (strontium ranelate) be suspended owing to the drug's unfavourable cardiovascular risk profile.

The EMA's Committee for Medicinal Products for Human Use (CHMP) took into account this initial advice from PRAC but also noted that there was no available evidence of an increased cardiovascular risk in patients treated with strontium ranelate who did not have a history of heart or circulatory problems. In addition, the CHMP noted that there were data to show a beneficial effect of strontium ranelate in preventing fractures, including in patients with a high fracture risk, indicating that the benefits of treatment continue to outweigh the risks.

Cardiovascular risk monitoring recommended
The CHMP considered that the cardiovascular risk associated with strontium ranelate can be managed by restricting use of the drug to patients without a history of cardiovascular problems who do not have alternative treatment options. The CHMP has also recommended that patients treated with Protelos have their cardiovascular risk monitored every six to 12 months and treatment stopped if any heart or circulatory problems develop.

Continue treatment in first instance
The MHRA is advising that patients currently taking Protelos for severe osteoporosis should continue to take their medicine and contact their doctor if they have any questions. Doctors should review any of their patients currently taking Protelos.

The SPC for Protelos has not yet been updated with the EMA recommendations but lists the following cardiovascular contraindications for use: current or previous venous thromboembolic events; uncontrolled hypertension; and a current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.

Summary of Product Characteristics for Protelos

Further information: Servier Laboratories Ltd

Follow MIMS on Twitter