EMA announces first restriction on drug use based on PSUR

EMA logoAt this week’s meeting of the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC), the decision was taken to restrict the use of Protelos/Osseor (strontium ranelate). Pending confirmation from the Committee for Medicinal Products for Human Use (CHMP), this will be the first time that a recommendation of this type has been made based on a Periodic Safety Update Report (PSUR) assessment.

This new robust mechanism to assess the benefits and risks of authorised 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