PRAC News – March 2015
PRAC recommends restrictions on the use of codeine for cough and cold in children
The PRAC has completed a review of codeine-containing medicines when used for cough and cold in children. It recommended a number of measures, including restricting the use of these medicines, to manage the risk of serious side effects including the risk of breathing problems.
This current review follows a previous review of codeine when used for pain relief in children. The recommended new restrictions for codeine for cough and cold are largely in line with the previous recommendations for codeine when used for pain relief.
More information is accessible on the HALMED’s webpages or here.
PRAC recommends further measures to minimise 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). 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.
More information on the PRAC March 2015 meeting may be viewed here.