Actifed, Humex… eight anti-cold treatments on prescription from Wednesday

Common Cold Medications Pulled From Shelves in France

Starting December 11, eight popular over-the-counter cold remedies will require a prescription in France due to growing concerns over their safety.

A Controversial Ingredient

The medications in question, including well-known brands like Active Rume, Actifed Cold, Dolirhume, Humex, Nurofen Cold, and Rhinadvil variations, all share one key ingredient: pseudoephedrine. While effective in decongesting stuffy noses and alleviating cold symptoms, pseudoephedrine has been linked to serious side effects like strokes and heart attacks.

The reason for their required prescription status stems from the “extensive contraindications, precautions for use, and known adverse effects” associated with pseudoephedrine, as stated by the National Medicines Safety Agency (ANSM). The agency emphasized that readily available access to these medications without medical consultation posed a significant risk to patients.

Balancing Risks and Benefits

Arguing that these medications are unnecessary due to the benign nature of the common cold, the ANSM first recommended against their use in 2023, causing a temporary dip in sales. However, sales rebounded by September, prompting the agency’s call for a prescription requirement.

The ANSM urged doctors to carefully evaluate the potential benefits and risks for each patient considering these medications. Prior to this change, these medications were readily available in tablet form, with nasal spray versions also requiring a prescription.

Why The Delay?

French health officials defended the delayed action, citing European regulations that bound them to follow the recommendations of the European Medicines Agency (EMA). Last year, the EMA determined that the cold medications in question didn’t warrant a complete ban, despite enforcing new contraindication guidelines.

Rare But Serious Side Effects

Despite the concerns, the EMA’s stance was partly justified by the rarity of serious side effects associated with these medications. Though a few cases are reported annually, no deaths have been directly attributed to these drugs in France.

A Polarizing Move.

The decision to implement a prescription requirement aligns with the position of prominent French medical societies, including ENT specialists, general practitioners, and pharmacists. They all advocate against the unrestricted use of these medications.

However, the move has sparked controversy among pharmacists, who argue that the restriction unfairly limits the range of over-the-counter options they can offer to customers seeking cold relief, especially given the ongoing challenges in securing timely doctor appointments.

They emphasize that for many patients, pharmacists serve as the first point of contact for managing minor ailments and believe this restriction will significantly hinder their ability to provide personalized advice and guidance.

“It will be more difficult for us to address our patients’ concerns. People will no longer have access to readily available medical advice, and we won’t have the opportunity to recommend alternative solutions,” stated Béatrice Clairaz-Mahiou, co-president of the French-speaking Society of Pharmacy Sciences, in


_{*The Pharmacist’s Daily.*}

Others criticize the delayed action, arguing that medical professionals have better uses for their time than advising patients against readily available medications now deemed potentially unsafe.

Would mandating prescriptions for‌ pseudoephedrine-containing⁢ medications, while aiming to mitigate ⁢risks, disproportionately impact patient‍ autonomy and strain healthcare resources?

Given ⁤teh potential risks associated wiht common cold medications containing pseudoephedrine, as highlighted by french health authorities, is​ it reasonable⁣ to require a prescription for thes drugs, or would‌ making them harder to⁣ access unnecessarily restrict ‍patient choice and burden doctors with trivial consultations?