2023-12-03 12:27:27
These medications, such as Actifed Rhume or Dolirhume, are singled out because of potential cardiovascular risks. The PRAC (pharmacovigilance) committee recommends do not use pseudoephedrine in people with severe or uncontrolled high blood pressure and those with kidney disease. The National Medicines Safety Agency (ANSM) criticizes the PRAC’s lack of attention to seriousness of the adverse effects and considers that this is a “missed opportunity” to guarantee patient safety.
In a recent decision, the European Medicines Agency’s (EMA) Risk Assessment Committee, known as PRAC, recommended new precautionary measures for cold treatments containing pseudoephedrinewithout call into question their availability in pharmacies. These medications, such as Actifed Rhume and Dolirhume, use pseudoephedrine to decongest the nasal mucous membranes, but this substance can also stimulate the heart rate and cause cardiovascular problemssuch as cerebrovascular accidents (CVA) and myocardial infarction.
This recommendation follows a request for re-evaluation of these treatments by the National Medicines Safety Agency (ANSM) in February, and explicit advice against their use by the ANSM in October. The PRAC now recommends that pseudoephedrine should not be used by people with severe or uncontrolled high blood pressure and those with kidney disease, but without banning or discouraging it more generally. Furthermore, he suggests to healthcare professionals to recommend that their patients stop using these medications if they develop symptoms such as severe headache, feeling unwell, vomiting, confusion, seizures, or blurred vision.
Despite these recommendations, the EMA must still receive the opinion of another committee before making a final decisionwho could take several months.The ANSM criticizes the PRAC decision, believing that it does not sufficiently take into account the seriousness of the adverse effects to which patients are exposed. For Séverine Carré-Pétraud, editorial director of the journal Prescrire, the PRAC opinion is “largely insufficient” and represents a “missed opportunity”.
An investigation by the Toulouse regional pharmacovigilance center identified nine cases of stroke and twenty-five myocardial infarctions in France between 2012 and 2018 linked to pseudoephedrine. Although these cases are rare, their seriousness is emphasized by health professionals. The ANSM had already banned for pseudoephedrine in 2017 and has been issuing information sheets to pharmacists and patients since 2020. Despite this, the union of manufacturers of non-prescription treatments, NèreS, believes that the benefit-risk ratio of oral vasoconstrictors remains positive.
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