A few weeks ago, the European Medicines Agency (EMA) announced that it would begin reviewing the hundreds of drugs that contain pseudoefedrina. The reason for this review is 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.
The agency safety committee (PRAC) warned that both syndromes cause a 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.
Thus, as the EMA has warned, 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the marketing authorizations for medicines containing pseudoephedrine should be maintained, modified, suspended or withdrawn throughout the EU.
What is pseudophedrine?
Pseudoephedrine is a pharmacologic agent that is taken orally and is used alone or in combination with other medications to treat nasal congestion against a cold, flu or allergy.
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.”
Medicines containing pseudoephedrine in Spain
The list published by the EMA includes hundreds of medicines, of which up to thirty are marketed in Spain. Among the best known that contain this pharmacological agent are some such as Gelocatil Influenza With Pseudoephedrine, Decongestive Frenadol or Cinfatós.
This is the complete list of medicines on the market in Spain that contain pseudoephedrine:
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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
It was already public knowledge that drugs 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.