WHO sounds alert over fake liver drug being sold in India, Turkiye

The WHO notification pertains to a counterfeit batch of liver medication known as DEFITELIO (defibrotide), which was identified in India in April 2023 and in Turkiye in July 2023, and was distributed through unauthorized channels.

WHO sounds alert over fake liver drug being sold in India, Turkiye
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The World Health Organization (WHO) has issued a warning regarding counterfeit DEFITELIO (defibrotide), a liver medication, which has surfaced in India and Turkiye. This fraudulent batch was initially identified in India in April 2023 and later in Turkiye in July 2023, indicating that it entered the market through unauthorized channels.

DEFITELIO is typically prescribed for the treatment of severe hepatic veno-occlusive disease (VOD) in individuals undergoing haematopoietic stem-cell transplantation therapy, spanning adults, adolescents, children, and infants aged one month or older.

The legitimate manufacturer has verified the presence of counterfeit products and underscored that DEFITELIO lacks authorization for sale in India and Turkiye. They have also provided guidelines to help identify the counterfeit medication.

According to the manufacturer, authentic DEFITELIO with Lot 20G20A comes in German/Austrian packaging, whereas the counterfeit products are packaged in UK/Ireland packaging. Additionally, the indicated expiry date on the counterfeit product does not align with the registered shelf life, and the stated serial number does not correspond to batch 20G20A.

Notably, the WHO had previously issued a warning about this same medication in May 2020 when counterfeit versions were found circulating in Argentina, Australia, Latvia, Malaysia, and Saudi Arabia.

The utilization of counterfeit DEFITELIO can result in ineffective treatment and pose significant health hazards. Consequently, the WHO strongly advises against using the fake medication and urges individuals who have used it or experienced adverse reactions to promptly seek medical guidance.