Hundreds of drugs that contain pseudoephedrine and are used to treat flu, cold or allergy symptoms, such as nasal congestion and runny nose, can increase the risk of developing diseases that affect the blood vessels of the brain, such as posterior reversible encephalopathy syndrome ( PRES) and reversible cerebral vasoconstriction syndrome (RCVS), and for this reason they are being reviewed by the European Medicines Agency (EMA).
Some of these drugs are sold in Spain without a prescription, so anyone can buy them at a pharmacy and self-medicate. In our country, for example, Gelocatil Gripe with pseudoephedrine tablets, Termalgin Cold, Frenadol decongestant capsules, Respidin Expectorante Junior, Iniston mucus and congestion, Vincigrip or Cinfatós Complex, among others, are marketed.
Pseudoephedrine is an active ingredient contained in these and other drugs that is taken orally and used alone or in combination with other substances to relieve nasal congestion that we experience when we have a cold, flu, or allergy. The EMA has published a list with hundreds of drugs available in the European Union, and around thirty are marketed in Spain.
What is pseudoephedrine and what are its risks?
The EMA has explained that pseudoephedrine stimulates nerve endings to release noradrenaline, a chemical that causes blood vessels to narrow, thereby decreasing the amount of fluid released from the vessels and reducing inflammation and the “production of runny nose.”
When the arteries in the brain are narrowed, symptoms such as a severe headache, dizziness, epilepsy or confusion occur.
The problem is that this can cause adverse effects such as PRES and RCVS, which “appear when the arteries in the brain narrow multiple times, causing symptoms such as a severe headache, dizziness, epilepsy, or confusion. They are reversible syndromes because we know they are transitory, but during the time they occur they can leave lifelong lesions”, warned Tomás Segura, a member of the Cerebrovascular Diseases Study Group of the Spanish Society of Neurology (SEN), in statements to the newspaper La Razón, although it also acknowledges that “these adverse effects have always been known by neurologists.”
The European agency has also reported that PRES and RCVS cause decreased blood supply to the brain, known as ischemia, and can cause serious and life-threatening complications in some cases. Headache, nausea, and seizures are the most common symptoms.
Although it was already known that medicines containing pseudoephedrine can cause cardiovascular and cerebrovascular ischemic problems, including stroke and heart attack and is something that is warned in their package leaflet, the European Committee for Pharmacovigilance (PRAC) will now review the available data to decide whether to maintain, modify, suspend or withdraw the marketing authorizations for drugs that contain this therapeutic agent.
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