After ten months of evaluation, the European Medicines Agency (EMA) has recommended minimizing the use of popular anticongestive drugs with pseudoephedrine in patients with hypertension or kidney disease to reduce the risk of posterior reversible encephalopathy syndrome (PRES) and of reversible cerebral vasoconstriction (SCRV).
These are conditions that can involve a reduction in blood supply to the brain, which can lead to serious and life-threatening complications. But, according to the EMA, these are rare cases and are generally resolved with timely diagnosis and treatment.
A month ago, France's drug regulator launched a campaign to advise against the use of a number of popular cold vasoconstrictors because of the risks of heart attack and stroke. “The risk is very weak, but these incidents can occur regardless of the dose and duration of treatment,” the organization argued.
Pseudoephedrine is a stimulant that is often used as a decongestant in people with colds or allergies. In Spain, pharmacies supply, with and without a prescription, 31 medications that contain this substance.
The Prac (EMA drug safety evaluation committee) indicates that they should not be used in patients with severe or uncontrolled high blood pressure or with severe, acute or chronic kidney failure or disease.
On the other hand, it has written an informative document in which it urges health professionals to advise patients to “stop using these medications immediately and seek treatment if they develop symptoms of PRES or RCVS, such as severe headache sudden onset, malaise, vomiting, confusion, seizures and visual disturbances.
The package inserts for all pseudoephedrine medications will be updated to incorporate the risks related to PRES and RCVS and new measures to be taken.
In its review, Prac has received advice from an expert group of general practitioners, otorhinolaryngologists, and a patient representative.
Pseudoephedrine works by stimulating nerve endings to release a chemical, noradrenaline, which constricts blood vessels. In this way, the amount of fluid released from the vessels is reduced, which means reducing swelling and mucus production in the nose.
These widely used medications are used alone or in combination with other drugs to treat cold and flu symptoms, such as headache, fever and pain, allergic rhinitis (inflammation of the nasal passages due to allergies), or rhinitis. vasomotor (inflammation of the nasal passages due to non-allergic or non-infectious causes), in people with congestion.
Pseudoephedrine is also approved in EU countries to treat aerotitis, an inflammation of the middle ear due to sudden changes in air pressure. In this case it is supplied in a fixed dose combination with triprolidine.
Regarding the isolated cases of PRES and RCVS registered in France, they represent “anecdotal situations,” Joan Martí-Fàbregas, head of the stroke unit at the Sant Pau hospital, explained to La Vanguardia.
In his opinion, there are no conclusive studies on the supposed risks: “In real life, millions and millions of people who take these medications do not have strokes. There is a small risk that is doubtful and anecdotal, and if it existed it would affect people who abuse more.”
The abuse of medicines that are so close at hand is problematic, explained Santi Grau, director of the medicine area at the Hospital del Mar, in Barcelona. “If you use psudoephedrine a lot, there is usually a tolerance effect whereby you need more doses to produce the same effect. And the frequency of administration increases, especially via the nasal topical route. There are very hooked people.”
In a document released on November 3, the Spanish Society of Clinical, Family and Community Pharmacy (Sefac) recommended “the responsible use of medications that contain pseudoephedrine and consulting the pharmacist,” although it specifies that most of these drugs contain more of five years marketed in Spain without any reports of cases similar to those registered in France. Sefac issued this warning with a view to the arrival of the flu and cold season.
