PRAC meeting highlights 24-27 October 2022

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing and monitoring safety issues for human medicines.

The current PRAC highlights from the October 2022 meeting describes measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders, outlines recommendations to withdraw the marketing authorisations for amfepramone obesity medicines, highlights the inclusion of heavy menstrual bleeding as a side effect associated with COVID-19 vaccine's Comirnaty and Spikevax, and recommends warnings for use of live vaccines in infants whose mothers received ustekinumab (Stelara) during pregnancy.