Measures for other intravenous bisphosphonates and denosumab to be considered in upcoming reviews

The European Medicines Agency (EMA) has completed a periodic review of Aclasta (zoledronic acid), one of the bisphosphonate medicines with a known risk of osteonecrosis of the jaw. The Agency concluded that the risk of osteonecrosis (or death of bone tissue) in the jaw remains very low, but has recommended a number of measures to minimise the risk, including an update to the product information and the introduction of a patient reminder card.

EMA is planning similar measures for other intravenous bisphosphonates and denosumab, used for osteoporosis or for preventing bone complications of cancers, as these are also associated with a risk of osteonecrosis of the jaw. Measures for these medicines will be considered during their upcoming and ongoing periodic reviews, which are planned to take place over the course of 2015/2016.

EMA’s Committee for Medicinal Products for Human Use (CHMP) has now adopted the recommendations for Aclasta, following a review by the Pharmacovigilance Risk Assessment Committee (PRAC).

The CHMP opinion will now be sent to the European Commission for a legally binding decision valid throughout the European Union (EU).


Posted on the EMA website on 27 March 2015