Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 9 – 12 January 2023

Alignment of dose recommendations for Janus kinase (JAK) inhibitors in patients with certain risk factors

EMA’s safety committee, PRAC has further reviewed measures to minimise the risk of serious side effects associated with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. The PRAC has recommended the use of a lower dose of Olumiant (baricitinib) for patients at higher risk of blood clots, cardiovascular conditions and cancer in line with the dosing recommendations for other JAK inhibitors subject to the review: Rinvoq (updacitinib), Cibinqo (abrocitinib) and Jyseleca (filgotinib).

More information is available in EMA’s public health communication.

New safety information for healthcare professionals…