EMA Launches Review of Liver Disease Drugs Containing Terlipressin

The European Medicines Agency’s (EMA) product safety committee has begun reviewing drugs treating an advanced liver disease that contain the active compound terlipressin.

In a large clinical trial, patients with hepatorenal syndrome given terlipressin saw a marked decline in kidney function and Danish health officials called for a safety review, the EMA said.

Terlipressin products are authorized in several EU countries to treat increased pressure in central veins that can cause kidney problems in people with the syndrome.

The drug is also indicated for treating bleeding from enlarged veins in the esophagus as well as some bleeding associated with surgery. But the safety review won’t cover terlipressin for treating bleeding since no new safety concerns have emerged for those uses, the agency said.