The Rwanda Food and Drug Authority (RFDA) has recalled from the market, Broncalene, a popular syrup used to treat dry coughs. The move comes after a study carried out by a French pharmaceutical agency found that “pholcodine,” an active ingredient of the medicine is linked to the increased risk of anaphylactic reaction – a severe, potentially life-threatening allergic reaction. Anaphylactic reaction causes, among other complications, an itchy rash, throat closing due to swelling which can obstruct or stop breathing; severe tongue swelling which can also interfere with or stop breathing. Earlier this month, France’s National Agency for the Safety of Medicines and Health Products (ANSM) alerted about “serious risk of allergies” regarding cough syrups that contain pholcodine. Pholcodine is an opioid drug that suppresses unproductive (dry) coughs in both adults and children, and also has a mild sedative effect. It works directly in the brain, depressing the cough reflex by reducing the nerve signals that are sent to the muscles involved in coughing. Pholcodine has been used as a cough suppressant since the 1950s The results of the study by ANSM suggested that taking pholcodine up to 12 months before general anesthesia may increase the risk of having an anaphylactic reaction. As a result of the findings, the French agency suspended all marketing authorizations for pholcodine-based cough syrups in France. Reacting to the development, the RFDA has also come out to recall both the adult and infant version of the Broncalene syrups, and instructed various actors in the supply chain to stop distributing the products. “Rwanda FDA instructs all importers, central medical stores, wholesalers, retailers, public and private health facilities to stop distribution and return the recalled products to the supplier for proper management,” reads part of the communique. “The importers and suppliers of recalled products are requested to report to Rwanda FDA within 15 days from the date of the recall the quantities imported, quantities distributed, quantities returned and final stock on hand,” it continues. Currently, the European Medicines Agency (EMA) is also undertaking a review of medicines that contain pholcodine due to similar concerns. The review was requested by the ANSM following preliminary results of the study it carried out on pholcodine.
