Other safety alerts
|
| |
| The United Kingdom: MHRA safety review of medicines containing pseudoephedrine |
| |
Medicines and Healthcare products Regulatory Agency (MHRA) announces that it is reviewing the available evidence relating to the very rare risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with pseudoephedrine-containing medicines. PRES and RCVS are rare, reversible conditions, and most patients fully recover with appropriate treatment.
Since these products were authorised, MHRA has received two United Kingdom Yellow Card reports of these possible side effects associated with pseudoephedrine, despite very widespread usage. The potential risk is considered to be very rare.
If signs or symptoms of PRES/RCVS develop, pseudoephedrine should be discontinued, and medical advice sought immediately. Symptoms reported include sudden onset of severe headache, nausea, vomiting, seizures, confusion and visual disturbances.
MHRA will provide any further advice as appropriate.
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. Someone with PRES may experience headache, changes in vision, and seizures, with some developing other neurological symptoms such as confusion or weakness of one or more limbs. Most patients fully recover from this condition.
RCVS is a neurological disorder characterised by a sudden onset of severe headache associated with narrowing of blood pipes (intracranial vessels) that supply blood to the brain. On brain imaging the narrowing of the blood vessels can look similar to “string of beads”. In addition to headaches RCVS can also present as medical emergency with strokes (ischaemic strokes or bleed), seizure or as brain oedema (brain swelling). Usually, the narrowing resolves by itself within three months hence it is called reversible vasoconstriction.
PRES and RCVS have previously been identified as very rare potential side effects associated with pseudoephedrine-containing products.
The European Medicines Agency’s (EMA) safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), is also conducting a review of pseudoephedrine.
Please refer to the following website in MHRA for details:
http://www.gov.uk/government/news/mhra-safety-review-of-medicines-containing-pseudoephedrine
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. Related news was previously issued by EMA, and was posted on the Drug Office website on 11 Feb 2023. The DH will remain vigilant on the conclusion of the review and safety update of the drug issued by MHRA and other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/Monday, Feb 27, 2023
Issued at HKT 14:00
|
| |
|
