Beginning December 10, French pharmacies will require prescriptions for eight common cold medications due to safety concerns regarding their potential side effects, including strokes and heart attacks. This decision, prompted by the National Agency for the Safety of Medicines (ANSM), highlights the risks associated with pseudoephedrine and aims to mitigate excessive hazards for patients. Critics argue that this may complicate care for cold sufferers, especially with ongoing challenges in accessing medical appointments.
New Prescription Requirement for Cold Medications in France
Starting Wednesday, December 10, French pharmacies will mandate a prescription for eight well-known cold remedies, which have garnered a reputation for being potentially harmful. This decision, announced by the National Agency for the Safety of Medicines (ANSM) on Tuesday, highlights concerns regarding the numerous contraindications, user precautions, and known adverse effects of pseudoephedrine. The agency emphasized that “considering the benign nature of the common cold, allowing access to these medications without medical guidance poses an excessive risk to patients.”
Health Risks Prompt Regulatory Changes
The cold treatments affected by this new regulation include popular products such as Actifed Rhume, Dolirhumepro Paracetamol Pseudoephedrine, and Doxylamine. Despite being recognized as dangerous for years, these medications were previously available over the counter. With the winter season approaching, health authorities deemed it crucial to address this issue. While these treatments can be obtained in tablet form without prescriptions, they are also available as nasal sprays but only with a doctor’s approval.
Criticism of these medications has grown over the years, particularly from the ANSM, due to their association with severe side effects, including strokes and heart attacks. In 2023, the agency took a significant step by explicitly advising against their use for the first time, resulting in a temporary decline in sales. However, sales began to rise again in September.
The ANSM remarked, “Despite implementing risk reduction measures, such as banning direct advertising and providing ongoing information on the risks associated with oral vasoconstrictors, the exposure to rare yet serious side effects has not sufficiently diminished.”
Questions have arisen as to why these medications were not banned earlier. French health authorities have explained that they were limited by European regulations, which require the European Medicines Agency (EMA) to approve any withdrawal of a license. However, last year, the EMA concluded that the risks associated with these cold treatments did not justify a ban, despite introducing new contraindications.
While serious side effects are infrequent, French authorities ultimately decided that the low-risk nature of these medications was unacceptable in light of the trivial condition they treat—a common cold. This stance is supported by major French scientific organizations, including ENT specialists, general practitioners, and pharmacists, all of whom oppose the use of these treatments.
This new regulation may pose challenges for pharmacists, many of whom feel that the restriction limits their ability to provide effective solutions for patients battling colds, particularly given the ongoing difficulty in securing medical appointments. “Responding to patients’ needs will become more complex. Without a doctor, we won’t be able to recommend anything,” stated Béatrice Clairaz-Mahiou, co-president of the Francophone Society of Pharmaceutical Sciences (SFSPO), in an interview with Quotidien du Pharmacien.
Conversely, some experts argue that health authorities have been slow to respond to the risks posed by these medications. As highlighted by the independent journal Prescrire, “Healthcare providers should not have to waste time advising patients against a medication that should be withdrawn from the market.”