EMA: Further measures to minimise risk of osteonecrosis of the jaw with bisphosphonate medicine
Measures for other intravenous bisphosphonates and denosumab to be considered in upcoming reviews The European Medicines Agency (EMA) has completed a periodic review1 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.