其 他 安 全 警 示
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| Singapore: Glypressin (Terlipressin): Serious or Fatal Respiratory Failure and Sepsis/septic shock in Patients with Type 1 Hepatorenal Syndrome (English only) |
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Health Sciences Authority (HSA) announces that A Dear Healthcare Professional Letter has been issued by Ferring Pharmaceuticals Pte Ltd to inform healthcare professionals of new safety updates regarding the use of terlipressin in patients with type 1 hepatorenal syndrome (type 1 HRS), based on results from the CONFIRM trial.
Terlipressin may cause serious or fatal respiratory failure at a frequency higher than previously known in these patients and may increase their risk of sepsis/septic shock. Terlipressin should be avoided in patients with advanced renal dysfunction [baseline serum creatinine ≥ 442 µmol/L (5.0mg/dL)] and those with Acute-on-Chronic Liver Failure (ACLF) grade 3 and/ or Model for End-Stage Liver Disease (MELD) score ≥ 39, unless the benefit outweighs the risks. Patients with new onset of breathing difficulties or worsening of existing respiratory disease should be stabilised prior to administering the first dose of terlipressin, with close monitoring during treatment. Patients should also be monitored for signs and symptoms of infection.
The Singapore package insert for Glypressin has been updated to add continuous intravenous (IV) infusion as a method of administration since this method may be associated with lower rates of severe adverse events as compared with IV bolus administration.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/glypressin-(terlipressin)-serious-or-fatal-respiratory-failure-and-sepsis-septic-shock-in-patients-with-type-1-hepatorenal-syndrome
In Hong Kong, there are 4 registered pharmaceutical products containing terlipressin. All products are prescription-only medicines. So far, the Department of Health (DH) has not received any case of adverse drug reaction related to terlipressin. Related news was previously issued by European Medicines Agency and the United Kingdom Medicines and Healthcare products Regulatory Agency, and was posted on the Drug Office website since 15 Jan 2022, with the latest update posted on 25 Mar 2023. Letters to inform local healthcare professionals were issued by the DH on 3 Oct 2022. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Saturday, Apr 22, 2023
Issued at HKT 12:00
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