This was previously a potential risk. According to a new study, the National Agency for the Safety of Medicines and Health Products (ANSM) has decided to suspend the market from this Thursday, September 8, for four cough syrups due to the risk of severe allergy to curares. A risk if the patient takes these syrups during general anesthesia, even several weeks after the medical procedure.
These are four syrups (Dimetane, two Biocalyptol syrups and Pholcodine Biogaran) used to relieve dry cough and dry cough in adults and children over 30 months and over 15 kg.
In a recent press release, the ANSM justifies its decision: “Given the non-essential nature of these syrups and the existence of therapeutic alternatives, their benefit-risk balance is considered unfavorable. For this reason we are considering suspending the marketing authorizations in France for pholcodine-based cough syrups.”
These products have been under strict scrutiny since 2009, resulting in prescription requirements starting in 2011. In 2020, the ANSM issued a notice urging doctors not to prescribe them and patients not to take them.
A call to caregivers
In January 2022, EMA’s Pharmacovigilance Committee (PRAC) recommended updating the Summaries of Product Characteristics and Package Leaflets of pholcodine-based medicines to include a warning about the risk of overdose and cross-reactions with curares, particularly based on new data.
In parallel with this market suspension, the agency also urges caregivers to ensure patients understand the importance of informing the anesthesiologist about the use of this type of syrup, even if they are old, when undergoing general anesthesia undergo.
A product recall
The ANSM is not only suspending these four cough syrups, but is also requesting a recall of all of these syrups these days. The Federation of Community Pharmacists (FSPF), which has not responded to our inquiries, states that the recall of batches of the four syrups currently in circulation must be initiated.
“If you are using or have already used a cough syrup containing pholcodine, no special monitoring is recommended at this time,” the drug’s agency specifies in its press release. However, if you need to have general anesthesia, the anesthesiologist may ask if you have already taken this type of syrup. Remember to let him know directly if he doesn’t ask you about it himself. »
There are other drugs as an alternative to these four syrups, it is advisable to consult your doctor more closely.