EMA Committee calls for curbs on Protelos/Osseor, tetrazepam suspension

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restrictions in the use of Protelos/Osseor (strontium ranelate, from Laboratoires Servier) based on the outcome of a routine benefit-risk assessment of the medicine, known as a periodic safety update report or PSUR.

Pending confirmation from the Committee for Medicinal Products for Human Use (CHMP), this will be the first time that a PSUR assessment leads directly to a recommendation to restrict the use of a medicine, the EMA says. This new robust mechanism to assess the benefits and risks of authorized medicines has been introduced by the new pharmacovigilance legislation. It makes the safety-monitoring of medicines even more swift and efficient, delivering regulatory action to ensure the safe and effective use of medicines for the benefit of patients.

At the meeting, the PRAC also recommended the suspension of tetrazepam-containing medicines following a review initiated at the request of France in January 2013. This type of procedure is triggered when a European Union member state or the European Commission considers that urgent action across the EU is necessary because of a safety issue with a medicine.