ROME – The European Medicines Agency is investigating some drugs dedicated to the treatment of cold and flu containing pseudoephedrine. The suspicion is that their frequent use may cause disorders of the blood vessels of the brain, such as posterior reversible encephalopathy and reversible cerebral vasoconstriction. The decision to investigate follows a small number of cases. The EMA will later decide whether the drugs can remain on the market, alternatively it will decide to withdraw them.
The two disorders can lead to reduced blood supply (ischemia) to the brain and, in some cases, can cause serious and life-threatening complications. Common symptoms include headaches, nausea, and seizures.
Pseudoephedrine-based cold and flu medicines ‘no urgent safety concerns’ for which the European Medicines Agency (EMA) has launched an investigation. It is the location ofItalian Medicines Agency (Aifa)who – as reported by Ansa – underlines how currently the benefit-risk ratio of these medicines “remains positive and there are no urgent safety issues that imply immediate restrictive actions on the use of these medicines”.