引 致 更 改 给 病 人 的 产 品 资 讯 的 药 物 不 良 反 应 警 示
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| Singapore: Pseudoephedrine and the rare risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) (English only) |
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Health Sciences Authority (HSA) announces that the European Medicines Agency (EMA) and UK Medicines and Healthcare products Regulatory Agency (MHRA) have completed their safety assessments on the risk of PRES and RCVS associated with pseudoephedrine. Their reviews considered information from post-marketing safety data and advice sought from their pharmacovigilance expert groups. The EMA acknowledged that while PRES and RCVS could lead to serious and life-threatening complications, these are rare conditions that generally resolve with prompt diagnosis and treatment. The MHRA’s review noted four reports of suspected PRES or RCVS with pseudoephedrine in the context of over 4 million packets sold in the UK in 2022 alone. Both agencies have contraindicated the use of pseudoephedrine in patients with severe or uncontrolled hypertension or severe renal disease, which are risk factors for PRES and RCVS, and recommended for the addition of warnings on these adverse events to the package inserts (PIs) or patient information leaflets (PILs) of pseudoephedrine-containing products. They have also recommended for healthcare professionals to advise their patients to stop using these products immediately and seek treatment if they develop symptoms of PRES or RCVS.
To date, HSA has not received any local adverse event report of PRES or RCVS associated with pseudoephedrine despite its long history and widespread use. In March 2024, one of the product registrants issued a Dear Healthcare Professional Letter to notify healthcare professionals about the risks of PRES and RCVS associated with the use of pseudoephedrine. HSA will work with the product registrants to strengthen the warnings on PRES and RCVS and their related symptoms in the PIs or PILs of pseudoephedrine-containing products registered locally.
Healthcare professionals are advised to take note of the advisories by the EMA and MHRA. They may also consider counselling their patients on symptoms that require immediate medical attention to facilitate the prompt detection of PRES and RCVS symptoms and the necessary medical intervention. These include sudden onset of severe headache, nausea, vomiting, visual disturbances, seizures and altered mental status.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/safety-alert/pseudoephedrine-and-the-rare-risk-of-posterior-reversible-encephalopathy-syndrome-(pres)-and-reversible-cerebral-vasoconstriction-syndrome-(rcvs)
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 HSA, EMA and MHRA, and was posted on the Drug Office website since 11 Feb 2023, with the latest update posted on 18 Mar 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, Apr 29, 2024
Issued at HKT 18:45
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