Marketing authorizations for cough syrups containing pholcodine may be suspended in France in the face of “significant risk“A serious allergy to muscle relaxants during anesthesia,” the National Drug Safety Agency announced on Monday, August 29.
“Taking a pholcodine-based cough medicine puts you at risk of serious allergies to muscle relaxants prescribed during general anesthesia, even if the anesthesia takes place several weeks after taking the drug, according to a new study.“Explains the health agency.
The syrups are: Dimetane without sugar (Biocodex), Biocalyptol and Biocalyptol without sugar (Zambon), Pholcodine (Biogaran). Since 2011, these opioid-based syrups, used to relieve dry coughs and irritation in adults and some children (over 30 months and over 15 kg), can only be supplied with a prescription in France because of the already potential risk.
Reminder at the beginning of September
Taking into account the preliminary results of the safety study in France following the European assessment, ANSM now considers “their unfavorable risk-benefit ratio“taking into consideration”the non-essential nature of these syrups and the availability of therapeutic alternatives“. “Therefore, we plan to suspend the marketing authorizations (AMM) of pholcodine-based cough syrups in France and to carry out a recall of all these syrups in early September.The pharmaceutical agency writes.
For patients who are using or have used a cough syrup containing pholcodine, “no specific monitoring is recommended at this time“They announce from ANSM. In the case of general anesthesia, the anesthesiologist may ask the patient if he has already taken this type of syrup. If this fails, the patient is asked to inform him. The ANSM urges anesthesiologists and resuscitators to ask patients if they have already used this type of syrup, and for doctors and pharmacists to explain the risk of cross-reaction to muscle relaxants in general anesthesia to patients who have already taken it.
In April 2020, during the Covid-19 pandemic, the risk of a serious allergic reaction associated with pholcodine led the ANSM to advise against the use of these cough syrups. In January 2022, the Pharmacovigilance Committee of the European Medicines Agency (EMA) proposed to update the summaries of product characteristics and package leaflets of pholcodine-based medicines, warning about the risk of abuse and cross-reaction with muscle relaxants, in particular, new the data.
Source: Le Figaro
