The European Medicines Agency (EMA) has issued a warning regarding the potential risk of ischemia associated with drugs containing pseudoephedrine. Pseudoephedrine is a common ingredient found in medications used to treat symptoms of the common cold and flu.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has initiated a review of these drugs due to concerns that pseudoephedrine may lead to ischemia, a condition that restricts blood flow and can have serious health consequences. The review was prompted by reports of cases involving Posterior Reversible Encephalopathy Syndrome (PRES) and Reversible Cerebral Vasoconstriction Syndrome (RCVS) in individuals using pseudoephedrine-based medications.
PRES and RCVS are conditions that affect the circulatory system and can result in reduced blood flow to the brain, increasing the risk of ischemia. The review aims to determine whether there is a causal relationship between pseudoephedrine and the risk of ischemia.
A list of medications containing pseudoephedrine has been released by the EMA, including drugs commonly used to alleviate cold and flu symptoms, allergies, fever, rhinitis, and nasal congestion. The EMA will assess the findings of the review and decide on any necessary actions to ensure the safety of these medications.
Individuals who are currently taking medications containing pseudoephedrine are advised to consult their healthcare provider for guidance on the appropriate course of action. The EMA continues to monitor the situation closely and will provide updates as new information becomes available.