The National Agency for the Safety of Medicines and Health Products (ANSM) in France has imposed new restrictions on the sale of eight common cold medications that were previously available over-the-counter, citing concerns about patient misuse and risks of contraindications.
ANSM has announced that all cold medications containing pseudoephedrine must be removed from pharmacy shelves and can only be obtained with a doctor’s prescription starting 11th December 2024.
Pseudoephedrine, an ingredient found in products such as Actifed Rhume, Dolirhume Paracétamol Pseudoephedrine and Doxylamine, is commonly available as nasal sprays or tablets.
In a statement on ANSM’s website, the health authority explained, “Last winter, we advised against using oral vasoconstrictors containing pseudoephedrine to relieve cold symptoms (nasal decongestants). This led to a temporary drop in sales without significantly reducing patient exposure. Since September 2024, we have observed a resurgence in sales. Risk-reduction measures, such as banning public advertising, issuing regular warnings about the dangers of oral vasoconstrictors, and providing practical guides for patients and pharmacists, have not sufficiently mitigated exposure to rare but serious side effects.”
The statement also highlighted new findings from the European Medicines Agency (EMA), which identified additional neurological risks associated with pseudoephedrine-containing medications. These risks are in addition to previously documented concerns, such as strokes and heart attacks.
“Given the numerous contraindications, precautions for use, and side effects of pseudoephedrine—and the mild nature of colds (which typically resolve within seven to ten days)—we believe over-the-counter availability poses an unacceptable risk to patients. As a result, pseudoephedrine has been reclassified under List I of poisonous substances, requiring a prescription for oral vasoconstrictors starting 11th December 2024. Medical advice will now be mandatory for their use,” ANSM stated.
The agency also urged physicians to “carefully assess the benefit/risk balance for each patient before prescribing one of these drugs.”
An outright ban on these medications was considered, but the EMA concluded that serious side effects are rare, and no deaths have been directly linked to pseudoephedrine use.
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