Highlights of EMA’s PRAC March meetings
The European Medicines Agency has released highlights of the March 9-12 meeting of its Pharmacovigilance Assessment Committee, which has resulted in recommendations of the use of bisphosphonates and of codeine.
PRAC recommends further measures to minimize known risk of osteonecrosis of the jaw associated with bisphosphonate medicine
The PRAC has conducted a periodic review, known as a periodic safety update single assessment (PSUSA), of one of the bisphosphonate medicines with a known risk of osteonecrosis of the jaw, Aclasta (zoledronic acid), market by Swiss pharma giant Novartis (NOVN: VX). The PRAC concluded that the risk of osteonecrosis of the jaw with this medicine remains very low but recommended measures, including updates to the product information and the introduction of a patient reminder card, to minimise this known risk.
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