The ANSM plans to suspend marketing authorizations for pholcodine-based cough syrups because of a risk of serious allergy to muscle relaxants, used in the event of anesthesia.
A new study reveals that pholcodine cough medicine, an active ingredient synthesized from opium, are associated with a risk of developing a serious allergy to muscle relaxantsused during anesthesia and even if the anesthesia takes place several weeks after taking the drug, alerts the Medicines Agency (ANSM) in a Sept. 1 statement. Curare is a derivative of plants from the Amazon rainforest that produces paralysis. The product is used exclusively in Anaesthesia and Intensive Care. Pholcodine-based syrups are used to soothe dry coughs and irritation coughs in adults and children over 30 months and over 15 kg. Since 2011, these drugs are only available in France on prescription.
“Given the non-essential nature of these syrups and the existence of therapeutic alternatives, we believe that the risk-benefit ratio of these drugs is unfavorable” indicates the National Agency for the Safety of Medicines and Health Products. The Agency plans to suspend marketing authorizations in France pholcodine-based cough syrups and to perform a reminder early september. The drugs concerned are:
- Dimetane without sugar 133 mg/100 ml, syrup (Biocodex)
- Biocalyptol 6.55 mg/5 ml sugar free syrup sweetened with sodium saccharin and liquid maltitol (Zambon)
- Biocalyptolsyrup (Zambon)
- Pholcodine Biogaran 6.55 mg/5 ml, syrup (Biogaran)
What should I do with my pholcodine cough syrups?
If using a pholcodine cough medicine:
► If you are going to have general anesthesia, tell your anesthesiologist.
► If you are not required to undergo a general anaesthetic, there is no particular monitoring recommended at the present time.
Source: Risk of serious allergy to muscle relaxants when using cough syrups containing pholcodine, ANSM, 1/09/22