Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 – 13 January 2022

Review of terlipressin medicines started

EMA has started a review of medicines that contain terlipressin. These medicines are authorised in several EU countries to treat increased pressure in central veins causing kidney problems in people with advanced liver disease (hepatorenal syndrome; HRS), as well as bleeding from enlarged veins in the passage between the mouth and the stomach (the oesophagus) and certain forms of bleeding associated with surgery.

EMA’s safety committee (PRAC) started this review due to safety concerns about results from a large clinical trial1 involving patients with a form of HRS where kidney function declines rapidly.

As a result of these concerns, the Danish medicines agency requested a review of the safety of terlipressin medicines in the context of their benefits when used to treat HRS. At present, this review does not cover the use of terlipressin for the treatment of bleeding, since no new information on safety concerns has emerged for these uses…