New measures for terlipressin-containing medicines in the treatment of hepatorenal syndrome
The PRAC recommended new measures to reduce the risk of respiratory failure (severe breathing difficulties that may be life-threatening) and sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) when using terlipressin-containing medicines in people with type 1 hepatorenal syndrome (HRS-1) (kidney problems in people with advanced liver disease).

Codeine with ibuprofen: PRAC adds warning for serious renal and gastrointestinal harms
The PRAC has recommended a change to the product information for codeine with ibuprofen combination medicines to include a warning of serious harms, including death, particularly when taken for prolonged periods at higher than recommended doses.

New safety information for healthcare professionals
As part of its advice on safety-related aspects to other EMA committees, the PRAC discussed a direct healthcare professional communication (DHPC) containing important information for terlipressin-containing medicines and Imbruvica.

Terlipressin: new recommendations for patients with type 1 hepatorenal syndrome
This DHPC is intended to inform healthcare professionals of an increased risk of respiratory failure and sepsis or septic shock in patients with type 1 hepatorenal syndrome (type 1 HRS) with terlipressin-containing medicines. This recommendation by the PRAC follows the review of available data, including results from a large clinical trial.

Imbruvica (ibrutinib): new risk minimisation measures, including dose modifications, due to the increased risk for serious cardiac events 
This DHPC aims to inform healthcare professionals about an increased risk of fatal and serious cardiac arrhythmias and cardiac failure with the use of ibrutinib.
Imbruvica is a medicine for treating the blood cancers mantle cell lymphoma, chronic lymphocytic leukaemia (CLL) and Waldenström’s macroglobulinaemia (also known as lymphoplasmacytic lymphoma).

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