New Warnings Issued for Medicines Containing Pseudoephedrine by European Medicines Agency
The European Medicines Agency (EMA) has issued new recommendations on the use of drugs containing pseudoephedrine, a stimulant commonly used as a nasal decongestant for colds or allergies. The decision to update the guidelines came from the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA, which aimed to minimize the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS).
Medicines containing pseudoephedrine are authorized in several European Union (EU) Member States and are used alone or in combination with other medicines to treat symptoms such as headache, fever, pain, allergic rhinitis, or vasomotor rhinitis in people with nasal congestion. They are also used for the treatment of aerotitis in fixed-dose combinations with other drugs.
However, the EMA warns that these medicines should not be used by individuals with severe or uncontrolled high blood pressure, or with severe acute or chronic kidney disease or failure. It is recommended that use of these medications be discontinued immediately if symptoms of PRES or RCVS develop, such as severe headache with sudden onset, nausea, confusion, seizures, and visual disturbances.
The updated guidelines have prompted concern in France, with alarm being raised over the use of pseudoephedrine in cold medicines. The warnings issued by the EMA serve as a reminder for healthcare professionals and consumers to exercise caution when using medications containing pseudoephedrine and to be aware of the potential risks associated with their use. It is important to consult a healthcare professional before using these medicines, particularly for individuals with underlying health conditions.