Authority recalls Ketoconazole oral tablets

Rwanda Foods and Drugs Authority, in its duty of ensuring the public health of the population, has withdrew Ketoconazole oral tablets from the Rwandan market.

The move follows the recommendations from the National Pharmacovigilance Advisory Committee.

Ketoconazole oral tablets are normally used to treat fungal infections.

Among the duties of Rwanda FDA governing pharmacovigilance for pharmaceutical products and medical devices, the authority has conducted a deep analysis and concluded that “Ketoconazole has higher risks of liver injury than its benefits when treating fungal infections”.

Hence the authority withdrew all the brands of Ketoconazole oral tablets from the Rwandan market and called for alternative drugs for the treatment of fungal infections.

It is against this background that Rwanda FDA ordered all Central Medical Stores

Pharmaceutical Wholesalers, Importers, Retail Pharmacies, Public and Private health facilities, Health professionals and the general public at large to stop the distribution and return the withdrawn medicines to the suppliers for management purposes.

FDA also urged all the importers and Suppliers of withdrawn products to report the quantities imported, quantities distributed, quantities returned and hand the final stock to Rwanda FDA within 15 days from the date of the withdrawal.

Importers of the mentioned medicines were requested to arrange the refund mechanism to their clients as per article 18 of the regulation governing the recall of regulated products.

For Health Professionals especially medical doctors and pharmacists, they were requested to stop prescribing and dispensing Ketoconazole oral tablets and use other alternative treatments.

Rwanda FDA’s mandate to ban medical products harmful to the population are established by the law Law Nº 003/2018 of 09/02/2018 establishing Rwanda Food and Drugs Authority

(Rwanda FDA), especially in articles 8 paragraphs 2 and 13 and reference is also made to regulation No CBD/TRG/016 governing pharmacovigilance for pharmaceutical products and medical devices, especially in article 26.

Prior to Ketoconazole, the authority had banned Toblereno chocolate and Broncalene sirups among other commodities.

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