The National Medicines Safety Agency announced that several medications previously available over the counter would now require a prescription.
Every winter, it’s hard to escape colds! Medications available over the counter in pharmacies are widely used by the French to treat this runny nose. But from this Wednesday, December 11, you will need a prescription – and therefore go to the doctor – to obtain eight cold medications based on pseudoephedrine.
This decision published by the National Medicines Safety Agency (ANSM) this Tuesday, December 10 was taken because of the serious risks associated with the use of these medications. They can in fact cause heart attacks, strokes, convulsions or even serious skin reactions. “These adverse effects can appear in patients without risk factors or medical history, regardless of the dose and duration of treatment,” warns the Medicines Agency.
According to a report from regional pharmacovigilance centers307 serious cases were reported between 2012 and 2018 after the use of decongestant vasoconstrictors based on pseudoephedrine. These tablets are already contraindicated in many cases: history of stroke, high blood pressure, history of convulsions, renal or hepatic failure… Even if they are low, the risks are serious for a benign illness which recovers from itself in 7 to 10 days. “We consider that the possibility of obtaining these medicines without medical advice poses too great a risk to patients,” estimates the Medicines Agency. The eight drugs affected are:
- Active Cold
- Actifed Cold day and night
- Dolirhume Paracetamol and Pseudoephedrine
- Dolirhumepro Paracetamol Pseudoephedrine and Doxylamine
- Humex Cold
- Nurofen Cold
- Rhinadvil Cold Ibuprofen/ Pseudoephedrine
- Rhinadvilcaps Cold Ibuprofen/ Pseudoephedrine.
This decision follows several years of alerts from the Medicines Agency. In 2017, it banned advertising for the general public. More recently, in 2023, the ANSM warned of the risks linked to these drugs. This communication had “resulted in a temporary drop in sales” but “without major impact on patient exposure”.
Since September 2024, sales have increased again, forcing the ANSM to take strong measures. However, health professionals consider that this decision to make these drugs only available by prescription is late, and would like a more drastic choice: a total ban on their sale. To treat a cold, doctors and pharmacists recommend washing the nose with physiological serum, a spray with sea water or thermal water.