Other safety alerts
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| European Union: PRAC starts safety review of pseudoephedrine-containing medicines |
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European Medicines Agency (EMA) announces that its safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), has started a review of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), conditions affecting blood vessels in the brain. Pseudoephedrine is taken by mouth and is used alone or in combination with other medicines to treat nasal congestion (a blocked nose) resulting from a cold, flu or allergy.
PRES and RCVS can involve reduced blood supply (ischaemia) to the brain and may cause major and life-threatening complications in some cases. Common symptoms associated with PRES and RCVS include headache, nausea and seizures.
The review follows new data from a small number of cases of PRES and RCVS in people using pseudoephedrine-containing medicines which were reported in pharmacovigilance databases and the medical literature.
Pseudoephedrine-containing medicines have a known risk of cardiovascular and cerebrovascular ischaemic events (side effects involving ischaemia in the heart and brain), including stroke and heart attack. Restrictions and warnings are already included in the medicines’ product information to reduce these risks.
Considering the seriousness of PRES and RCVS, the overall safety profile of pseudoephedrine and the indications for which the medicines are approved, the PRAC will review available evidence and decide whether the marketing authorisations for pseudoephedrine-containing medicines should be maintained, varied, suspended or withdrawn across the European Union.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/prac-starts-safety-review-pseudoephedrine-containing-medicines
In Hong Kong, there are 105 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. The DH will remain vigilant on the conclusion of the review and safety update of the drug issued by EMA and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Saturday, Feb 11, 2023
Issued at HKT 12:00
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