- Medicines and Healthcare products Regulatory Agency
- Therapeutic area:
- Endocrinology, diabetology and metabolism and Rheumatology
Restricted indication and new monitoring requirements.
Article date: March 2014
The European Medicines Agency (EMA) has concluded its review of the risks and benefits of strontium ranelate (Protelos). The EMA considered that strontium ranelate should only be used by people for whom there are no other treatments for osteoporosis. The cardiovascular risks identified with strontium ranelate may be sufficiently reduced in this population by restricting its use to people without cardiovascular contraindications (as advised in April 2013—see below) and by monitoring cardiovascular risk regularly.
Advice for healthcare professionals:
- Strontium ranelate is now restricted to the treatment of severe osteoporosis in postmenopausal women and adult men at high risk of fracture who cannot use other osteoporosis treatments due to, for example, contraindications or intolerance
- Treatment should only be started by a physician with experience in the treatment of osteoporosis
- The risk of developing cardiovascular disease should be assessed before starting treatment. Treatment should not be started in people who have or have had:
- ischaemic heart disease
- peripheral arterial disease
- cerebrovascular disease
- uncontrolled hypertension
- Cardiovascular risk should be monitored every 6–12 months
- Treatment should be stopped if the individual develops ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease, or if hypertension is uncontrolled