News item | 02-12-2022 | 11:00
Terlipressin may increase the risk of (life-threatening) breathing problems in patients with HRS type 1. This side effect is more common than previously known. Terlipressin can also increase the risk of blood poisoning (sepsis) or septic shock. This is a serious condition that develops when a serious infection causes low blood pressure and supply. This is shown by research in the United States and Canada into the drug. Medicines Authority MEB warns doctors and pharmacists about this.
Terlipressin is given in hospital as emergency treatment of hepatorenal syndrome type 1 (HRS type 1). This syndrome sometimes occurs in patients with severe liver abnormalities. In patients with this syndrome, kidney function rapidly deteriorates and problems with other organs also arise.
Severe breathing difficulties is a known side effect of terlipressin. New clinical studies show that patients with HRS type 1 taking terlipressin are more likely to experience this side effect than previously reported in the product information. An association between sepsis/septic shock and terlipressin has been established for the first time in patients with HRS type 1. This side effect will be added to the product information.
Advice to doctors
- Avoid treatment with terlipressin in patients with severe renal impairment unless the expected benefit outweighs the risks.
- Avoid use of terlipressin in patients with severe liver disease (ACLF grade 3 and/or MELD score ≥ 39) unless the expected benefit outweighs the risks.
- If necessary, stabilize patients with breathing difficulties prior to terlipressin administration. Monitor these patients closely during treatment. Consider dose reduction of human albumin, if used if patient develops breathing difficulties. Discontinue terlipressin if symptoms are severe or do not resolve.
- Monitor patients for signs of infection.
- Terlipressin can be administered as a continuous intravenous (iv) infusion. It appears that this mode of administration is less likely to cause serious side effects compared to administration via an iv bolus.
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Risk information letter
The companies Ferring BV, Alliance Pharma (Ireland) Limited and Altan Pharma Ltd have sent a letter on this subject, a so-called Direct Healthcare Professional Communication (DHPC). The letter containing this important risk information has been sent in consultation with the MEB and the Health and Youth Care Inspectorate (IGJ) to: hepatologists, nephrologists, gastroenterologists, intensive care specialists, liver transplant experts, hospital pharmacists and care providers in training.
The identification and analysis of side effects throughout the entire life cycle of a medicine is called pharmacovigilance or pharmacovigilance. This is a core task of the MEB. In case of urgent and/or important safety issues, medical professionals are informed by means of a DHPC.