The European Medicines Agency (EMA) has issued a warning about the use of medicines containing pseudoephedrine, an active ingredient commonly used to treat nasal congestion. The agency has recommended that these medicines should not be used in patients with severe or uncontrolled high blood pressure, chronic acute renal disease or failure. This announcement comes after the Pharmacovigilance Risk Assessment Committee (PRAC) conducted a review of the safety of products containing pseudoephedrine, following reported cases by the French Medicines Agency.
According to the EMA, there have been reports of posterior encephalopathy syndrome (PRES) and cerebral vasoconstriction syndrome (RCVS) occurring in individuals who have used pseudoephedrine-containing medicines. These conditions can lead to a reduced blood supply to the brain and potentially cause serious and life-threatening complications. Symptoms of PRES and RCVS include severe headache with sudden onset, feeling sick, vomiting, confusion, seizures, and visual discomfort. The EMA advises healthcare professionals to advise patients to immediately stop using pseudoephedrine-containing medicines and seek specific therapy if they experience these symptoms.
The general secretary of the Federation of general practitioners (Fimmg), Silvestro Scotti, cautioned that drugs containing pseudoephedrine are not a cure for colds and may actually prolong the duration of symptoms. Scotti mentioned that pseudoephedrine can be useful in specific situations, such as when a person is unable to sleep due to a stuffy nose and has important commitments the next day. However, he emphasized the importance of consulting with a doctor before using pseudoephedrine-containing medicines, especially for patients with risk factors or those who plan to use the drug over an extended period of time.
In light of these findings, the EMA has announced that information about the risks of PRES and RCVS associated with pseudoephedrine will be indicated on the products containing this active ingredient. The agency’s recommendation serves as a reminder for both patients and healthcare professionals to use caution when considering the use of medicines containing pseudoephedrine, especially in individuals with underlying health conditions.