Rwanda FDA investigates paediatric medicines found unsafe by WHO

Officials at the Rwanda Food and Drug Authority (RFDA) have investigated and found that the four paediatric medicines that were recently found unsafe by the World Health Organisation (WHO) in The Gambia have never entered the Rwandan market. Earlier this month, the WHO issued an alert that Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup contain “unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.” “Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal,” the WHO said. The four products-all manufactured by Maiden Pharmaceuticals Limited, India-were only identified on The Gambian market, but the WHO warned that they may have been distributed, through informal markets, to other countries or regions. In a communique issued on Saturday, October 8, the RFDA said it carried out local investigations in regards to the WHO's alert, and found that the products are not on the Rwandan market. Rwanda FDA has checked in the import system and found that the concerned products have never entered the Rwandan market, read part of the RFDA's statement. It added that the products from the manufacturer (Maiden Pharmaceuticals) are not on the lists of registered or authorised medicines in Rwanda. Rwanda FDA will continue the import control and surveillance on the market, the statement read, before calling upon the public to report any suspected quality or safety issue on any medicines. More about the risks associated with the four drugs: According to the WHO, diethylene glycol and ethylene glycol-the two substances found in the four medicines- have toxic effects that can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death. It added that the four medicines are unsafe and their use, especially in children, may result in serious injury or death. “National regulatory/health authorities are advised to immediately notify WHO if these substandard products are discovered in their respective country,” read part of the WHO statement.

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Rwanda FDA investigates paediatric medicines found unsafe by WHO