Medicines for colds, the EMA investigates pseudoephedrine
The European Medicines Agency Ema announces the start of a safety review of medicines containing pseudoephedrinean active substance administered orally alone or in combination with others to treat stuffy nose caused by cold, flu or allergy, and symptoms related to nasal congestion such as headache, fever, pain and rhinitis.
The Pharmacovigilance Committee Prac of the EU regulatory body, in its last meeting on 6-9 February, decided to investigate these drugs – he explains the Emma – after fears related to serious ischemic risks associated with taking pseudoephedrinepotentially life-threatening.
The Prac will review the available evidence and decide whether marketing authorizations for medicines with pseudoephedrine must be maintained, modified, suspended or withdrawn throughout the European Union.
A motivating review of drug-based pseudoephedrine – details the Emma – is the possible risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), conditions that affect the cerebral blood vessels and which can lead to a reduced blood supply (ischemia) to the brain and in some cases cause serious and life-threatening complications. The common symptoms associated with Pres And RCVs they include headache, nausea, and seizures.
The review follows new data on a small number of cases of Pres And RCVs in people using medicines containing pseudoephedrinereported in pharmacovigilance databases and in the medical literature.
Medicines containing pseudoephedrine – the agency recalls – have a known risk of ischemic cardiovascular and cerebrovascular events, including stroke and heart attack. Restrictions and warnings to reduce these risks are therefore already included in the product information.
But considering the severity of Pres And RCVsthe safety profile of the pseudoephedrine and the indications for which it is approved, the Prac will analyze all available information and decide whether to change or revoke the authorization of the medicines that contain it.
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