France Bans Over-the-Counter Sale of Eight Anti-Cold Drugs
Starting December 11, 2024, French health authorities will require a prescription for eight popular anti-cold medications, including Dolirhume, Actifed Rhume, and Humex. This decision, announced by the National Agency for the Safety of Medicines and Health Products (ANSM), is aimed at mitigating the risks associated with these drugs, which contain the vasoconstrictor pseudoephedrine. The ANSM has long warned about the potential for serious side effects, including strokes and heart attacks, associated with these medications, which are often used to treat the common cold—a condition that typically resolves on its own.
Health Risks Prompt Regulatory Action
The ANSM's decision comes after years of criticism regarding the safety of pseudoephedrine-based treatments. Despite being available over the counter, these medications have been linked to severe adverse effects, with 307 serious cases reported between 2012 and 2018. Alexandre de La Volpilière, deputy director general of the ANSM, emphasized that the risks of serious health issues do not justify the use of these medications for a condition as benign as a cold. The agency has urged healthcare providers to carefully evaluate the benefit-risk balance before prescribing these drugs.
Industry Reaction and Future Implications
The ban has sparked surprise among pharmaceutical companies, which argue that the decision contradicts the European Medicines Agency's (EMA) stance that existing warnings were sufficient. However, the ANSM maintains that the risks associated with these medications are unacceptable, especially given the mild nature of the common cold. Pharmacists have expressed concerns that this restriction will complicate their ability to assist patients, particularly in a healthcare landscape where access to medical appointments is often limited. Observers note that the health authorities may have acted too slowly in addressing these risks, with calls for a ban dating back several years.
