French pharmacies will now require prescriptions for eight cold medications containing pseudoephedrine, following a regulatory decision by the National Agency for the Safety of Medicines (ANSM). Citing significant health risks, including serious side effects, the ANSM aims to enhance patient safety, especially with winter approaching. This change has raised concerns among pharmacists about limited access to care, while experts argue for more proactive measures to protect patients from harmful treatments.
Prescription Requirement for Cold Treatments in France
Beginning Wednesday, French pharmacies will require a prescription for eight popular cold medications that have been deemed potentially dangerous. This regulatory change comes from the National Agency for the Safety of Medicines (ANSM), which cited the significant risks associated with the active ingredient pseudoephedrine.
The ANSM stated, “Given the numerous contraindications, usage precautions, and known side effects of pseudoephedrine, along with the generally mild nature of the common cold, allowing access to these medications without medical supervision presents too high a risk to patients.” This decision was announced on Monday and has been anticipated for some time.
List of Affected Medications
The medications now requiring a prescription include well-known brands such as Actifed Cold, Dolirhume Paracetamol and Pseudoephedrine, and Nurofen Cold, among others. All of these treatments contain pseudoephedrine, which has been criticized for its potential to cause serious side effects, including strokes and heart attacks.
Despite being available over the counter for years, the growing concerns about the safety of these medications prompted French health authorities to reconsider their availability, especially with winter approaching. While these treatments are primarily used to relieve nasal congestion, their risks have led to heightened scrutiny from health professionals.
In 2023, the ANSM publicly recommended against their use for the first time, causing a brief decline in sales; however, these products have seen a resurgence in sales since September.
The ANSM highlighted that previous risk mitigation strategies, such as banning advertising and providing educational materials for patients and pharmacists, have not sufficiently reduced exposure to the rare but serious side effects associated with these medications.
Despite European regulations complicating the withdrawal process, the ANSM’s decision reflects a growing consensus among French medical societies that these treatments should no longer be available without a prescription. This move has sparked concern among pharmacists, who fear it limits their ability to provide care amidst ongoing challenges in accessing medical appointments.
As the healthcare landscape evolves, some experts argue that more decisive action was needed sooner to protect patients from potentially harmful medications. The debate continues over the balance between patient access to treatment and ensuring safety in pharmaceutical care.