Other safety alerts
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| Singapore: Zyrtec-D: Risks of posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome associated with the use of pseudoephedrine |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by GlaxoSmithKline Pte Ltd to inform healthcare professionals of the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with the use of pseudoephedrine-containing medicines.
There have been a few overseas cases of PRES and RCVS that have been reported in patients taking pseudoephedrine-containing medicines. Most cases resolved following discontinuation and appropriate treatment.
Healthcare professionals are encouraged to exercise careful discretion when prescribing or dispensing pseudoephedrine-containing medicines, and adhere to the labelled contraindications, warnings and precautions in order to mitigate the risk of occurrence of PRES or RCVS. Patients should be advised to immediately stop using pseudoephedrine-containing medicines and seek medical assistance if signs or symptoms of PRES or RCVS develop. The local package insert of Zyrtec-D (containing cetirizine and pseudoephedrine) will be updated to include further information on these adverse events and measures to reduce the risks.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/zyrtec-d---risks-of-posterior-reversible-encephalopathy-syndrome-and-reversible-cerebral-vasoconstriction-syndrome-associated-with-the-use-of-pseudoephedrine
In Hong Kong, there are 99 registered pharmaceutical products containing pseudoephedrine. All products are pharmacy only medicines. So far, the Department of Health (DH) has received 2 cases of adverse drug reaction related to pseudoephedrine, but these cases were not related to PRES or RCVS. 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 11 Feb 2023, with the latest update posted on 21 Feb 2024. Letters to inform local healthcare professionals were issued by the DH on 4 Dec 2023. As previously reported, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/Monday, Mar 18, 2024
Issued at HKT 15:00
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