The review was initiated following a small number of cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), conditions affecting blood vessels in the brain. Within the EU, pseudoephedrine-containing medicines are available under various brand names, including Actifed, Aerinaze, Aspirin Complex, Clarinase, Humex rhume and Nurofen Cold and Flu. Pending further analyses, the products will not be withdrawn for now and the Italian Agency reassures: “There is no urgent safety problem”. THE EMA NOTE
10 FEB – EMA’s 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 medicines 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 follows new data from a small number of cases of PRES and RCVS in people using pseudoephedrine-containing medicines that have been reported in pharmacovigilance databases and medical literature.
Pseudoephedrine-containing medicines 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 product information of the medicines.
Considering the severity of PRES and RCVS, the safety profile of pseudoephedrine and the indications for which the medicines are approved, the PRAC will review the available evidence and decide whether the marketing authorizations for pseudoephedrine-containing medicines should be maintained. modified, suspended or withdrawn across the EU.
Read more about the medicine
Pseudoephedrine works by stimulating nerve endings to release norepinephrine, which causes blood vessels to constrict (narrow). This reduces the amount of fluid released from the vessels, resulting in less swelling and less mucus production in the nose.
Pseudoephedrine-containing medicines 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.
Within the EU, pseudoephedrine-containing medicines are available under various brand names, including Actifed, Aerinaze, Aspirin Complex, Clarinase, Humex rhume and Nurofen Cold and Flu.
Read more about the procedure
The review of medicines containing pseudoephedrine was initiated at the request of the French medicines agency (ANSM) pursuant to article 31 of directive 2001/83/EC where, according to what is learned, 10 cases would have emerged on people who, however, already had if some risk factors.
The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for 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), responsible for questions relating to medicinal products for human use, which will adopt an opinion. The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Aifa reassures: “No urgent safety issues”. In relation to the European referral procedure for pseudoephedrine-based medicines, launched by the European Medicines Agency (EMA), AIFA specifies that “currently the benefit/risk ratio of these medicines remains positive and there are no urgent safety issues involving immediate restrictive actions on the use of this class of medicines”.
“The safety profile of these drugs – continues the Medicines Agency – will be extensively reviewed on the basis of the available epidemiological, clinical and pharmacovigilance data. As usual, the Agency will provide updates on the ongoing procedure as they become available. The ongoing procedure demonstrates the continued monitoring of efficacy and safety profiles on all medicines. We reiterate the importance of using these drugs in compliance with the recommendations contained in the Package Leaflet and in the Summary of Product Characteristics”.
Source: Ema and Aifa
February 10, 2023
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