PRAC Requests Supplementary Info From Antiretrovirals Related to Autoimmune Hepatitis

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee is requesting that sponsors of antiretrovirals submit, by May 8, supplementary safety information related to the risk of autoimmune hepatitis.

The request is related to more than 40 products and combinations from the largest manufacturers of HIV medications, including AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck Sharp & Dohme, Roche and ViiV Healthcare.

The PRAC also asked for supplementary information from Sanofi Clir related to Plavix (clopidogrel) and insulin autoimmune syndrome. Merck Sharp & Dohme was asked to assess the risk of cholangitis sclerosing in its next periodic safety update report for Keytruda (pembrolizumab). Sponsors of products containing the antidepressant amitriptyline were asked to provide comments on proposed label updates related to reports of dry eye.