Medicines containing pseudoephedrine increase the risk of blood vessel disorders in the brain, as well as cardiovascular or cerebral ischemic accidents. The European Medicines Agency (EMA) has announced new regulations to reduce the risks.
The danger of cold and flu medicines – Photo Archive
The EMA has announced that it is approving measures proposed by experts to reduce the risks associated with the administration of medicines containing pseudoephedrine. Specifically, the European Agency recommends that these drugs should not be used by patients with severe or uncontrolled hypertension and those suffering from acute or severe chronic renal failure, according to an EMA statement.
The drugs are associated with the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). Although they are considered rare conditions that affect the blood vessels in the brain, they can cause life-threatening complications.
Furthermore, patients who experience sudden headache, nausea, vomiting, confusion, convulsions, and visual disturbances after taking medications containing pseudoephedrine should discontinue treatment and consult a physician.
Doctors from various fields, such as general practitioners, ENT specialists, allergists, as well as a patient representative participated in the evaluation of this type of medicine, based on all available evidence.
The new information will also appear on the pseudoephedrine cold and flu treatment package insert. There are already warnings in the leaflet to reduce the risks of ischemic cardiovascular and cerebrovascular accidents, including stroke and myocardial infarction.
In which drugs do we find pseudoephedine
Medicines for colds and flu are sold without a prescription, and Romanians do not go to the doctor every time they need it. That is why, in our country, these drugs are very popular, and people are not aware that they have certain risks, especially since the leaflet is rarely read, considering that we are talking about well-known drugs.
In the European Union, we find medicines containing pseudoephedrine under different trade names such as: Actifed, Aerinaze, Aspirin Complex, Clarinase, Humex rhume and Nurofen Cold and Grip.
In Romania, the substance is found in many medicines recommended for colds and flu such as: Tedolfen Cold and Flu, Parasinus Cold and Flu, Nurofen Cold and Flu, Ibusinus, Modafen, BioFlu, Paduden Cold and Flu and others.
This substance, pseudoephedrine, works by stimulating nerve endings to release a chemical, noradrenaline, which causes vasoconstriction (narrowing) of blood vessels. That is, it reduces the amount of fluid in the blood vessels, to decrease inflammation and reduce the amount of nasal secretions.
Treatment with such drugs, for cold, flu or allergy, should not last more than 7 days. Pseudoephedrine is taken orally.
The substance can be used both on its own and in combination with other active substances. In some EU Member States it is authorized to treat symptoms of respiratory viruses such as headache and fever, allergic rhinitis or vasomotor rhinitis in people with nasal congestion. Moreover, it can be used to treat aerotitis, in combination in a fixed dose with triprolidine.