The Algerian health authorities decided, this Tuesday, January 10, 2023, to suspend the marketing authorization and to withdraw all pholcodine-based syrups, including the generics Biocalyptol and Dénoral.
Yesterday, January 10, 2023, the Ministry of Health issued a circular, for the benefit of pharmacists, health professionals and resuscitators, which announces the suspension of the marketing authorization (AMM) and the withdrawal of the Algerian market all syrups that contain pholcodine.
Why the ban on pholcodine, what is its danger?
The latter is a substance found in particular in syrups against dry cough, including the one widely consumed by Algerians, the Biocalyptol. According to recent studies, pholcodine can cause dangerous allergic reaction in case of general anesthesia.
| READ ALSO: Antibiotics without a medical prescription, what you need to know
Moreover, the press release from the Ministry of Health indicates that it is necessary, on the one hand, “to continue the follow-up and the interrogation on the taking of the product (pholcodine, editor’s note), even months before anesthesia» ; on the other “add on the anesthesia sheet the notion of taking pholcodine in the months preceding the act. »
Copy of the Ministry of Health circular on the suspension of pholcodine-based syrups.
Following this warning, health professionals are calling on Algerians to stop consuming pholcodine-based dry cough syrups, such as Biocalyptol and Denoral, and bring the bottles back to the pharmacy. Apoce, in turn, relayed the information on its Facebook page.
the European Union also decides to ban pholcodine
Algeria is not the first country to ban and remove syrups containing pholcodine from the market. Francein September 2022, then the European Union in December, made the same decision.
| READ ALSO: “Algeria will produce insulin from January 10”, reveals Aoun
In the press release announcing its decision to ban pholcodine-based cough syrups, the European Medicines Agency EMA stresses that “the use of pholcodine in the previous twelve monthsmay cause, at the time of general anesthesia, an anaphylactic reaction, sudden, severe, life-threatening allergic reaction“.
On December 2, 2022, the European Union decided to ban syrups containing pholcodine.
This means that these syrups, taken by both adults and children, can be very dangerous even when consumed long before anesthesia. Used since the 1950s, they are now marketed through the brands Dimetane, Biocalyptol, Broncalene and Pholcodine Biogaran.
For its part, the French Medicines Safety Agency (ANSM), which took the decision to suspend the marketing of pholcodine-based cough syrups, explains that “taking these syrups exposes you to a risk important to make a severe allergy to muscle relaxants“. The latter being substances with a paralyzing action, used in anesthesia and intensive care.
| READ ALSO: Children in food supplement ads, ARAV says stop
Finally, you should know that alternatives to these cough syrups exist. Your doctor or pharmacist can advise you on this.
