Officials at the European Medicines Agency has recommended restricting the use of Servier's osteoporosis treatment Protelos to reduce the risk for adverse cardiac events in postmenopausal women.
The agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has made the recommendation following a routine benefit-risk assessment of Protelos/Osseor (strontium ranelate), known as a periodic safety update report (PSUR). Pending confirmation from the EMA's Committee for Medicinal Products for Human Use (CHMP), this will be the first time that a PSUR leads directly to restricted use of a medicine.
The PRAC looked at data obtained from clinical studies in about 7,500 patients which it says shows that there was an increased risk of a heart attack in postmenopausal women taking Protelos compared with placebo, although there was no increase in deaths. The committee says the data were of concern "given other serious risks (blood clots and rare serious skin reactions) that were identified in a previous EMA review in 2012".
It has now recommended that Protelos should only be used for the treatment of severe osteoporosis in postmenopausal women and men at increased risk for fracture. It also suggests the Servier drug should not be used in patients with current or past history of ischaemic heart disease (such as angina or myocardial infarction), peripheral arterial disease or cerebrovascular disease or in patients with hypertension that is not treated.
These restrictions will be sent to the CHMP, which will adopt a final opinion at its next meeting later this month. The European Commission will then issue a final decision.
The PRAC has also recommended the suspension of drugs containing tetrazepam following a review initiated at the request of France in January 2013.