Translation of a-t 2025; 56: 8

Cold remedies containing pseudoephedrine require a prescription in France

The French Drug Authority ANSM introduced a prescription requirement for cold remedies containing pseudoephedrine (e.g. BOXAGRIPPAL, RHINOPRONT) in December 2024 with immediate effect.¹ The authority has long advised against the peroral sympathomimetic with a vasoconstrictive effect,^1,2 which is associated with cardiovascular and ischaemic risks (hypertension, heart attack, stroke, ischaemic colitis among others).³ The risk assessment completed in 2024 by the European pharmacovigilance committee PRAC on two further serious ischaemic and cerebrovascular effects, posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), was also initiated by France. The French member of Committee for Medicinal Products for Human Use (CHMP) did not agree with the outcome – the inclusion of additional contraindications and warnings in the summaries of product characteristics (a-t 2023; 54: 106 among others), making the list of restrictions to be taken into account, which was already a long one in any case, even more confusing: France classifies the measures as insufficient, among other things because PRES and RCVS have occurred in patients with no risk factors. The newly identified harmful effects are in addition to the numerous known serious adverse effects, which continue to be observed despite existing contraindications and warnings,⁴ also in Germany, as a report⁵ on generalised coronary spasms and heart attack linked to a fixed combination of acetylsalicylic acid and pseudoephedrine (e.g. ASPIRIN COMPLEX) published recently by the Drug Commission of the German Medical Association shows. In light of the benign, self-limiting course of colds and the merely symptomatic effect of pseudoephedrine, France rates the benefit/harm ratio of the sympathomimetic as negative.⁴ However, no other country has followed this position. We have long considered that peroral cold remedies containing pseudoephedrine still being available without a prescription in Germany is irrational and alarming, and we feel that market withdrawal is overdue. A requirement for a prescription could at least be an initial measure for improved risk minimisation, but is not currently planned in Germany,⁶ –Ed.

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