Cold and flu remedies, Ema’s survey of health risks

Cold and flu medication alert. The EMA has initiated an investigation into possible health risks associated with the use of certain types of pseudoephedrine-containing medicines. The EMA safety committee (PRAC) has launched a review of pseudoephedrine-containing medicines following the possible risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), conditions that affect blood vessels in the brain. Pseudoephedrine is taken by mouth and is used alone or in combination with other medications to treat nasal congestion (stuffy nose) resulting from a cold, flu or allergy. PRES and RCVS can lead to reduced blood supply (ischemia) to the brain, and in some cases can cause serious and life-threatening complications. Common symptoms associated with PRES and RCVS include headache, nausea, and seizures. The review, reminds Aifa in an information sheet published on its portal, follows new data from a small number of cases of PRES and RCVS in people who use drugs containing pseudoephedrine that have been reported in pharmacovigilance databases and in the medical literature . Medicines containing pseudoephedrine have a known risk of ischemic cardiovascular and cerebrovascular events (side effects involving ischemia in the heart and brain), including stroke and heart attack.

Restrictions and warnings to reduce these risks are already included in the medication leaflet. Considering the severity of PRES and RCVS, the safety profile of pseudoephedrine and the indications for which the drugs are approved, the PRAC will review the available evidence and decide whether marketing authorizations for drugs containing pseudoephedrine should be maintained, modified, suspended or withdrawals across the European Union Medicines containing pseudoephedrine are authorized in several EU Member States alone or in combination with 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.

In the European Union, drugs containing pseudoephedrine are available under various trade names, including Actifed, Aerinaze, Aspirin Complex, Clarinase, Humex rhume and Nurofen Cold and Flu. The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the committee responsible for assessing the safety issues of human medicines, which will make a set of recommendations. The PRAC recommendations will then be forwarded to the Committee for Medicinal Products for Human Use (CHMP), which is responsible for questions concerning medicinal products for human use, which will issue an opinion. The final stage of the review process is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.