Pseudoephedrine, EMA launches analysis on the active ingredient in cold medicines – breaking latest news

Medicines containing pseudoefedrinaan active ingredient effective against nasal congestion, could cause (reversible) damage to blood vessels in the brain.

For this the Safety Committee (Prac) of the European Medicines Agency has initiated a product safety reviewwhich follows a small number of cases indicated by the French Medicines Agency.

The reports, in particular, concern posterior encephalopathy syndrome (Pres) e cerebral vasoconstriction syndrome (RCVs), both reversible, which occurred in people who had used the drug.

Pseudoephedrine (taken orally) is used alone or in combination with other medicines in case of stuffy nose caused by cold, flu or allergy.

Pres and Rcvs can cause a reduced blood supply (ischemia) to the brain and, in some cases, cause serious and life-threatening complications. Common symptoms associated with Pres and Rcvs include headaches, nausea, and seizures.

Medicines containing pseudoephedrine

Medicines containing pseudoephedrine work by provoking the narrowing of blood vessels: The risk of ischemic, cardiovascular and cerebrovascular events (undesirable effects involving ischemia in the heart and brain), including stroke and heart attack, has been known for some time.

Restrictions and warnings to reduce these risks they are therefore already included in the package inserts: to understand if there is this active ingredient in a drug you need to look at the leaflet
.

However, the Prac will examine the available evidence and decide whether the marketing authorizations for pseudoephedrine medicines should be maintained, varied, suspended or withdrawn across the European Union.

Pseudoephedrine-containing medicines are authorized in several EU Member States alone or in combination with others for the treatment of cold and flu symptoms such as headache, fever and pain or allergic rhinitis (inflammation of the nasal passages).

Vasoconstriction and hypertension

The risks associated with pseudoephedrine are well known,” he comments Francesco Scaglione, professor of Pharmacology at the University of Milan and clinical pharmacologist at the Niguarda Hospital —. Any vasoconstrictor drug can have systemic effects (vasoconstriction and hypertension) if the doses or frequency are exaggerated. People with heart disease or hypertension they must take these medicines very carefully and I believe that these products should only be sold on prescription, precisely because of the risks they entail in the event of prolonged or frequent use.

The advice, even for healthy people, to take medicines such as pseudoephedrine or similar only for the time and in the quantities strictly necessary.