The Italian Medicines Agency (AIFA) has issued a ban on specific drugs for the treatment of colds and nasal congestion, particularly those containing pseudoephedrine. The agency’s warning comes in the wake of recent cases of encephalopathy syndrome and reversible cerebral vasoconstriction syndrome in patients who have taken drugs containing pseudoephedrine.
AIFA has strongly recommended that certain categories of patients, including those with severe or uncontrolled hypertension, acute or chronic kidney disease, or renal failure, immediately discontinue the use of these drugs. The agency has emphasized the importance of protecting these patients as their conditions increase the risk of developing the aforementioned syndromes.
In a press release, AIFA listed symptoms that patients should be aware of, including sudden, intense headaches, nausea, vomiting, confusion, seizures, and vision problems. The agency has advised patients to seek medical assistance if they experience any of these symptoms after discontinuing the use of the banned drugs.
While the warning is important, AIFA has noted that all reported cases of encephalopathy syndrome and reversible cerebral vasoconstriction syndrome have been resolved with the discontinuation of the drugs and appropriate treatment. No deaths have been reported in connection to the use of these drugs.
It is important to note that the European Medicines Agency (EMA) had previously warned about the serious contraindications of these drugs in December 2023. Among the popular products affected by the ban are Actifed, Aerinaze, Aspirin Complex, Clarinase, Humex rhume, and Nurofen Influenza Cold. The ban has been issued in collaboration with European regulatory authorities.