After ten months of evaluation, the European Medicines Agency (EMA) has recommended minimizing the use of the popular decongestant drugs with pseudoephedrine in patients with hypertension or with kidney disease to reduce the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (SCRV).
These are conditions that can involve a reduction in blood supply to the brain, which can cause serious and potentially fatal complications. But, according to the EMA, these are rare cases and generally resolve with timely diagnosis and treatment.
A month ago, France’s medicines regulator launched a campaign to advise against the use of a number of popular vasoconstrictors for colds because of the very weak risk of myocardial infarction and stroke. “These incidents can occur regardless of the dose and duration of the treatment,” argued the organization.
Pseudoephedrine is a stimulant that is often used as a decongestant in people with colds or allergies. A, pharmacies supply, with and without a prescription, 31 medicines containing this substance. The PRAC (EMA drug safety assessment 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 information document in order to urge health professionals to advise patients to “stop using these medicines immediately and seek treatment if they develop symptoms of PRES or RCVS, such as severe headache of sudden onset, malaise, vomiting, confusion, convulsions and visual disturbances”. The leaflets of all pseudoephedrine medicines will be updated to incorporate the new risks described and the measures to be taken.
Pseudoephedrine works by stimulating nerve endings to release a chemical called norepinephrine, 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 drugs, which are widely used and have well-known brand names, 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 nostrils due to allergies) or vasomotor rhinitis (inflammation of the nostrils due to non-allergic or non-infectious causes) in people with congestion.
Pseudoephedrine is also authorized in EU countries to treat aerootitis, 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 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 drugs do not have strokes. There is a small risk that is dubious and anecdotal, and if there was, it would affect the people who abuse it more.”
Abuse is problematic, as explained by Santi Grau, who is the director of the drug area at the Hospital del Mar: “If you use a lot of pseudoephedrine, you usually develop a tolerance effect that makes you need more doses to get the same effect. And the frequency of administration increases, especially by topical nasal route. There are very clingy people”.
