The European Medicines Agency (EMA) has begun a review of hundreds of medicines containing pseudoefedrina. The agency’s safety committee (PRAC) initiated the procedure this February in response to concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), diseases that affect the blood vessels of the brain.
Pseudoephedrine is a pharmacologic agent that is taken orally and is used alone or in combination with other medications to treat nasal congestion before a cold, flu or allergy. In the list published by the EMA there are hundreds of medicines and about thirty are marketed in Spain. Among them there are well-known drugs such as Gelocatil Influenza With Pseudoephedrine, Decongestive Frenadol or Cinfatós.
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Rino-Ebastel
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Narine Repetabs
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Clarityne Plus
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lasa with codeine
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Pseudoephedrine Farmalider
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Gelocatil Gripe Con Pseudoefedrina
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Cold Termalgin
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Decongestant Frenadol
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Frenaxsin
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Reactine
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Inistolin Pediatric Cough And Congestion
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Iniston Mucus And Congestion
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Iniston Cough And Congestion
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Grippal With Pseudoephedrine And Dextromethorphan
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Rinobactil
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Pharmafren
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Decongestive cymphatos
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Respidine Expectorant Junior
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Cinfatós Comple
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Pharmatusgrip
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Respidin
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Antiallergic Respidin
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Vincigrip
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Vincigrip Forte Cocoa Flavor
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Vincigrip Forte Orange Flavor
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Ilvisinus
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Virlix Plus
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Ibuprofen/Pseudoephedrine Nutra Essential
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bisolfren
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Cortafriol C
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stop cold
The EMA explains that pseudoephedrine stimulates nerve endings to release the chemical norepinephrine, which causes blood vessels to narrow. “This reduces the amount of fluid released from the vessels, resulting in less inflammation and less mucus production in the nose.”
Serious and life-threatening syndromes
According to information released by the European agency, PRES and RCVS cause reduced blood supply (ischemia) to the brain and can cause serious and life-threatening complications in some cases. Its most common symptoms are headache, nausea, and seizures.
Given the risk of these two syndromes, the PRAC will review the available evidence and decide whether the marketing authorizations for medicines containing pseudoephedrine should be maintained, modified, suspended or withdrawn throughout the EU.
However, it should be remembered that it was already known that medicinal products containing pseudoephedrine have a known risk of cardiovascular and cerebrovascular ischemic events, including stroke and heart attack. These warnings are already included in the package insert.