PRAC February 2022
February 21, 2022
During its February 2022 meeting, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency recommended suspending hydroxyethyl-starch solutions for infusion from the market. Furthermore, the PRAC starts a safety review of Janus kinase inhibitors for inflammatory disorders.
Source: FAMHP
Suspension of hydroxyethyl-starch solutions for infusion from the market
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommends the suspension of the marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion across the European Union. These products were authorised as an addition to other treatments for plasma volume replacement following acute (sudden) blood loss.
Safety review of Janus kinase inhibitors for inflammatory disorders
The PRAC started a review of the safety of Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders (rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, ulcerative colitis and atopic dermatitis).