RWANDA – Rwanda Food and Drug Administration (FDA) has announced that Ketoconazole Tablets intended for treatment of fungal infections shall be withdrawn from Rwanda market.

The authority said, according to the safety assessment done based on national pharmacovigilance data as well as other worldwide evidences, the national pharmacovigilance advisory committee found that the higher risk of liver injury outweighs the benefits in fungal infections treatment.

The authority decided the withdrawal of the drug from market and orders importers, distributors and healthcare service providers to stop distribution and prescribing the drug product, withdraw their stock and report to the authority within the specified time period.

Rwanda FDA advised to health professionals in the country to use other anti-fungal options in the market for the treatment of fungal infections as appropriate.

This comes two years after the country recalled a Kenyan-made Ketoconazole (Kenazole) Cream USP 2%w/w anti-fungal cream following complaints of poor packaging that damages its quality standard.

“Referring to the spontaneous reports from the clients, retail pharmacies and further investigation conducted by the Rwanda FDA, where Ketoconazole Cream 2% was found poorly packaged where it gets out of its package while in storage,” said Dr Charles Karangwa, the acting director-general of Rwanda FDA.

According to the statement, the recalled drug, batch number 1907205 of 07/2019 and expiry date of 06/2022 is manufactured by Dawa Ltd Kenya and imported into Rwanda by Abacus Pharma (A) Ltd.

“Rwanda Food and Drug Authority instructs all importers, central medical stores, wholesale pharmacies, district pharmacies, retail pharmacies, public and private health facilities in possession of the incriminated batch to stop distribution, dispensing and return them to their suppliers,” Dr Karangwa said.

He further instructed all importers and the distributors of the cream to report on quantities distributed, returned quantities and available stock within 10 working days.

Ketoconazole cream is prescribed for several types of fungal infections including ringworm, athlete’s foot, jock itch, thrush infections of the skin and vagina, and skin conditions.

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