Medicines and Healthcare products Regulatory Agency (MHRA) announces that there have been very rare reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) with pseudoephedrine.
A review of the available evidence, including the assessment of cumulative reporting of adverse drug reaction reports, was considered by the Pharmacovigilance Expert Advisory Group (PEAG) of the Commission on Human Medicines (CHM). The PEAG recommended updates to the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL) to further describe the risk of PRES and RCVS and the potential risk factors for these conditions, and advised the MHRA to remind healthcare professionals and patients of these risks.
PRES, also known as reversible posterior leukoencephalopathy syndrome (RPLS), is a rare condition in which parts of the brain are affected by swelling, usually as a result of an underlying cause such as severely elevated blood pressure, kidney failure, severe infections, certain medications, some autoimmune diseases and pre-eclampsia. The diagnosis is usually made by imaging of the brain, which may enable areas of swelling to be identified. PRES usually has an acute onset characterised by headaches and seizures; many people also experience visual changes, confusion and drowsiness, weakness of the arm and/or leg on one side of the body (hemiplegia), difficulty speaking, or more rarely other neurological symptoms.
RCVS, also known as Call-Fleming syndrome, is a rare condition characterised by thunderclap headaches which are sudden, intense headaches that can reoccur over a few days to weeks and are often associated with nausea and sensitivity to light. RCVS can also be associated with acute neurological symptoms such as seizure and stroke. Symptoms are thought to arise from transient constriction in the blood vessels of the brain. In some cases, RCVS may be associated with childbirth, vasoactive or illicit drug use, head trauma, autoimmune or blood disorders, or complications of pregnancy. RCVS is usually diagnosed by brain imaging with angiography, to identify constrictions in cerebral blood vessels.
For both conditions, patients typically fully recover within 3 months with early recognition and treatment.
To date, the MHRA has received 4 Yellow Card reports of suspected PRES or RCVS with pseudoephedrine. This is in the context of widespread usage with over 4 million packets sold in the United Kingdom in 2022 alone.
Advice for healthcare professionals:
- PRES and RCVS present with the following symptoms: sudden severe headache or thunderclap headache, sudden onset of nausea and vomiting, confusion, seizures and/or visual disturbances.
- PRES and RCVS are recognised very rare side effects with pseudoephedrine-containing medicines, which are used for the symptomatic treatment of nasal and sinus congestion with colds, flu and allergies.
- Pseudoephedrine is for short term use only and should not be used for prolonged or extended use.
- Use of the product is contraindicated in patients with severe hypertension or uncontrolled hypertension, or severe renal disease.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/pseudoephedrine-very-rare-risk-of-posterior-reversible-encephalopathy-syndrome-pres-and-reversible-cerebral-vasoconstriction-syndrome-rcvs
In Hong Kong, there are 100 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 MHRA, and was posted on the Drug Office website since 11 Feb 2023, with the latest update posted on 27 Jan 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/Wednesday, Feb 21, 2024
Issued at HKT 14:30
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