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 your risk of blood poisoning (sepsis) or septic shock. This is a serious condition that develops when a severe infection causes low blood pressure and blood supply. This is evidenced by research in the United States and Canada on the drug. The MEB Medicines Authority warns doctors and pharmacists about this.
Terlipressin
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 deteriorates rapidly, and problems with other organs also arise.
Severe breathing difficulties are 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 the 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 respiratory distress before administration of terlipressin. Closely monitor these patients during treatment. Consider reducing human albumin dose, 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 than administration by intravenous bolus.
Risk disclosure letter
The companies Ferring BV, Alliance Pharma (Ireland) Limited and Altan Pharma Ltd have sent a letter on the matter, 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 Inspectorate for Health and Youth (IGJ) to: Hepatologists, Nephrologists, Gastroenterologists, Critical Care Specialists, Liver Transplant Experts, Hospital Pharmacists and health professionals in training.
The identification and analysis of side effects throughout the life cycle of a medicine is called pharmacovigilance or pharmacovigilance. This is a fundamental task of the MEB. In the event of an urgent and/or important safety issue, healthcare professionals are notified via a DHPC.
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