PRAC News – May 2015
Review of Tysabri started
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) started two new safety reviews at its May 2015 meeting. The PRAC started a review of the multiple sclerosis medicine Tysabri (natalizumab). The aim of the review is to assess whether the advice given to healthcare professionals and patients on how to manage the known risk of progressive multifocal leukoencephalopathy (PML) with this medicine should be revised in the light of new scientific evidence.
A Dear healthcare Professional Letter on this safety issue was addressed to healthcare professionals in April 2015, that you may read about on the HALMED webpages, or here.
Review of inhaled corticosteroids used to treat chronic obstructive pulmonary disease started
The Committee also began a review of inhaled corticosteroids used to treat chronic obstructive pulmonary disease (COPD). The review aims to further evaluate the known risk of pneumonia when these medicines are used for COPD.
For an overview of all information available following the meeting of the PRAC, see here.