These common cold medicines could pose health risks, EMA investigation

The EMA investigates some cold medicines, those that contain pseudoephedrine. There are in fact risks to be evaluated, in particular it is suspected that they may favor pathologies of the blood vessels of the brain

In case of a cold we have different types of medicines available, useful for relieving the symptoms and trying to heal a little faster. There is a doubt, however, that some are not entirely sure. Let’s talk about medicines containing pseudoefedrinathe use of which could be linked to the appearance of pathologies of the blood vessels of the brain.

Try to clarify this delicate issueEuropean Medicines Agency (EMA) and more precisely the PRAC (EMA’s safety committee) which has decided to launch an investigation into some drugs that contain pseudoephedrine. This active ingredient would be responsible for the appearance of:

• posterior reversible encephalopathy syndrome (PRES)
• reversible cerebral vasoconstriction syndrome (RCVS)

This was made necessary following a request from the French medicines agency which had reported to EMA a small number of cases in which patients who had taken pseudoephedrine-based drugs had subsequently developed the aforementioned pathologies. The two syndromes can involve a reduced blood supply to the brain and, in some cases, have serious consequences.

Pseudoephedrine is taken by mouth (alone or in combination with other active ingredients) to treat nasal congestion that results from a cold, flu, or allergies.

Between drugs whose possible serious side effects are being investigated There are:

• Active
• Aerinaze
• Aspirin Complex
• Clarinase
• Humex rhume
• Nurofen Cold and Flu

However, the PRAC recalls that, in reality, the risk of possible (albeit rare) cerebrovascular side effects is already known. In a statement he writes:

Pseudoephedrine-containing medicines have a known risk of ischemic cardiovascular and cerebrovascular events (side effects involving ischemia in the heart and brain), including stroke and heart attack. Restrictions and warnings are already included in the product information of medicines to reduce these risks.

The comment of the AIFA

The Italian Medicines Agency (Aifa) reassures by claiming that there is no “no urgent safety issues” for pseudoephedrine-based drugs.

At the moment, the ratio of benefits and harms of using such drugs:

It remains positive and we do not see any urgent safety issues requiring immediate restrictive actions on the use of these medicines.

Naturally, it is now important to re-examine in a more precise manner and on the basis of the most recent epidemiological, clinical and pharmacovigilance data available, the safety profile of these medicines. AIFA will also take care of updating on the developments of this investigation.

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Font: EMA / AIFA

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