The European Medicines Agency (EMA) has launched an investigation into some cold and flu medicines containing pseudoephedrine;
the suspicion is that their use is linked to diseases of the blood vessels of the brain: posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
The review follows a "small number of cases", says the EMA which will later decide whether the drugs can remain on the market or whether they need to be withdrawn.
Products containing pseudoephedrine include Actifed, Aerinaze, Aspirin Complex, Clarinase, Humex rhume, and Nurofen Cold and Flu.
The review of medicines containing pseudoephedrine was initiated at the request of the French medicines agency, alerted by a small number of cases of posterior reversible encephalopathy syndrome and reversible cerebral vasoconstriction syndrome in people who had used medicines containing the substance.
The two disorders can lead to reduced blood supply (ischemia) to the brain and, in some cases, can cause serious and life-threatening complications.
Common symptoms include headaches, nausea, and seizures.
Medicines containing pseudoephedrine work by causing the blood vessels to narrow.
This reduces the amount of fluid released from the vessels, resulting in less swelling and less mucus production in the nose.
They are available alone or with other medicines to treat cold and flu symptoms, such as headache, fever and pain, or allergic rhinitis (inflammation of the nasal passages) in people with nasal congestion.
The EMA points out that it is already known that they present a risk "of ischemic cardiovascular and cerebrovascular events", "including stroke and heart attack. Restrictions and warnings to reduce these risks are already included in the product information of the medicines".
including stroke and heart attack.
Restrictions and warnings to reduce these risks are already included in the product information of the medicines."
including stroke and heart attack.
Restrictions and warnings to reduce these risks are already included in the product information of the medicines."