From Wednesday 11 December the over-the-counter sale of many cold medicines will be discontinued. On this date, the French health authorities made it mandatory to present a prescription at the pharmacy to receive eight famous cold treatments, considered perilous.
- Active Rume,
- Active cold day and night,
- Dolirhume paracetamol and pseudoephedrine,
- Dolirhumepro Paracetamol Pseudoephedrine and doxylamine,
- Humex Rhume,
- Cold Nurofen,
- Rhinadvil Cold, Ibuprofen/Pseudoephedrine,
- Rhinadvilcaps Ibuprofen/Pseudoephedrine cold.
What all of these drugs have in common is that they contain the molecule pseudoephedrine. “In consideration, on the one hand, of the numerous contraindications, precautions for use and known adverse effects of pseudoephedrine and, on the other, of the benign nature of the common cold”this is the opinion of the National Agency for the Safety of Medicines (ANSM). “the possibility of obtaining these drugs without medical advice represents too great a risk for patients”according to a decision revealed on Monday 9 December.
“Carefully evaluate the risk/benefit ratio”
Available without a prescription in tablet form, these treatments – also sold via prescription nasal spray – aim to decongest and unclog the nose. These are therefore the main drugs used against colds. But, for several years, they have been the subject of numerous criticisms, starting with the ANSM. According to the agency, they can cause serious side effects such as strokes and heart attacks.
“We ask prescribers to carefully evaluate the risk/benefit ratio for each patient before prescribing any of these drugs”adds the ANSM, whose decision is awaited.
In 2023 the agency had, for the first time, explicitly advised against its use. This opinion had, for a time, caused a decline in sales of anti-cold treatments.But since September they have seen a recovery.
“The risk reduction measures we have put in place, such as the ban on advertising to the general public, regular information on the dangers of oral vasoconstrictors, as well as the provision of practical documents for patients and pharmacists, have not sufficiently reduced the population exposed to the risk of rare but serious adverse reactions.writes the ANSM.
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Why not ban them first? The French health authorities have explained that their hands are tied by European legislation which makes the revocation of an authorization subject to the opinion of the European Medicines Agency (EMA). However, it estimated last year that the anti-cold treatments in question did not pose enough risks to ban them, even if they imposed new contraindications.
Rare side effects
This opinion is justified by the rarity of serious side effects. A few are reported every year and, in France, no deaths have been reported. The French authorities ended up deciding that the risk,even low,was unacceptable given the benign nature of the disease to be treated: the cold.
This position is in line with that of the main French scientific societies (ENT, general practitioners, pharmacists) who all oppose the use of these drugs. There is a risk of offending pharmacists, many of whose representatives believe that this restriction unfairly reduces the range of medicines that can be offered to customers suffering from colds, in a context characterized by recurring difficulties in obtaining medical appointments.
“It will become complex for us to respond to patients’ problems. People will no longer have a doctor and we will no longer be able to advise anything.”estimated, in The pharmacist’s daily newspaper, Béatrice Clairaz-Mahiou, co-president of the Francophone Society of Pharmaceutical sciences.
For other observers, health authorities took too long to react. “Caregivers have better things to do than waste time counseling patients against a drug that should be withdrawn from the market”estimated, at the beginning of the year, the autonomous review Prescribe.
How have the new regulations on cold medicines in France impacted public access to these treatments?
Time.news Interview: A Discussion on Cold medicines and Health Regulations
Editor: Good afternoon,and welcome to Time.news. Today we have an crucial topic to discuss regarding cold medications, which is especially timely with the new regulations coming into effect in France. Joining us is Dr. Claire Dupont, a pharmacologist and expert in drug safety. dr. Dupont, thank you for being here.
Dr.Dupont: Thank you for having me. It’s a pleasure to be here.
editor: Let’s dive right in! As of December 11th, the French health authorities have mandated that specific cold medicines can only be obtained with a prescription. What prompted this notable change?
dr.Dupont: The decision was mainly driven by safety concerns regarding pseudoephedrine, a common ingredient found in numerous over-the-counter cold medications. The National Agency for the Safety of Medicines (ANSM) pointed out that the risks associated with these drugs, such as serious side effects like strokes and heart attacks, outweigh the benefits in treating a benign condition like the common cold.
Editor: Are ther specific medications that fall under this new regulation?
Dr. Dupont: Yes, eight well-known cold treatments have been identified. They include active components such as Active Rume, Dolirhume with paracetamol and pseudoephedrine, and Rhinadvil Cold, among others. All these products contain pseudoephedrine, which is where the concerns lie.
Editor: It sounds like a reasonable measure, especially considering the potential risks. How are these medications typically used, and why do they necessitate such caution?
Dr. Dupont: These medications are primarily used for decongestion. While they can provide temporary relief from cold symptoms, they also come with a myriad of contraindications and precautions. The ANSM has emphasized the importance of physicians evaluating the risk versus benefit for each patient, as overuse or misuse can lead to serious health issues.
Editor: What has been the response from both the medical community and the public regarding these changes?
Dr. Dupont: The response has been mixed. While many in the medical community support stricter regulations to protect patients, there have been concerns about accessibility. Patients often rely on these medications for relief, and moving them to prescription status may complicate things for many. It’s a balancing act between ensuring patient safety and maintaining accessibility to necessary treatments.
Editor: I understand that there was a temporary decline in sales of these anti-cold treatments earlier this year.Has this trend continued, or have sales rebounded since the initial advisory?
Dr. Dupont: Interestingly, even after the ANSM’s advice against their use earlier this year, we saw a resurgence in sales by September. This indicates a cultural reliance on these medications, despite the warnings and the emerging evidence of their risks. The challenge lies in changing public perception and encouraging safer practices.
Editor: the ANSM has taken measures to ban advertising and provide better information about these medications. How effective do you believe these measures will be in altering public behavior?
Dr.Dupont: These measures are a step in the right direction, but changing consumer behavior takes time.Continuous public education about the potential dangers of these medicines and promoting discussions between patients and their healthcare providers are critical. Prescribing practices can also play a significant role in how patients perceive the safety of these medications.
Editor: As we wrap up, what advice would you give to our viewers regarding the use of over-the-counter cold medications?
dr.Dupont: I would advise them to be cautious. Always consult a healthcare professional before taking any medication, especially those containing pseudoephedrine. it’s essential to weigh the risks against the benefits, and alternative treatments may be available that carry fewer risks.
Editor: Thank you, Dr. Dupont, for sharing your insights on this critical issue. It’s clear that while cold remedies might bring short-term relief, we must remain vigilant about their long-term effects on health.
dr. Dupont: Thank you for having me. It’s vital to keep this conversation going.
Editor: Absolutely. Thank you to our audience for joining us today. Stay informed and consult your healthcare providers for the best course of action for your health.
