The World Health Organisation has issued an alert against a fake liver medication called DEFITELIO (Defibrotide) being sold in India and Turkiye. The alert refers to a fake batch of the medication which was detected in India in April 2023 and Turkiye later in July 2023 which was supplied outside regulated channels.

DEFITELIO is used for treating severe hepatic veno-occlusive disease (VOD) in haematopoietic stem-cell transplantation therapy for adults, adolescents, children and infants over a month old. The genuine manufacturer said that DEFITELIO does not have marketing authorisation in India and Turkiye. According to the UN health body, the genuine manufacturer of DEFITELIO has confirmed that the product referenced in the alert is falsified.

“The genuine manufacturer has advised that: Genuine DEFITELIO with Lot 20G20A was packaged in German/Austrian packaging.The falsified products instead are in UK/Ireland packaging. The stated expiry date is falsified and does not comply with the registered shelf life. The stated serial number is not associated with batch 20G20A. The drug does not have marketing authorization in India and Türkiye.”

The WHO has recently reiterated its warning:

The WHO had previously sounded alerts over the same medication back in May 2020 when the product was found being sold in Argentina, Australia, Latvia, Malaysia, and Saudi Arabia. The WHO has now come forward to warn people to not use the fake product as the use of the falsified product will reduce the effectiveness and pose serious health threats. The WHO also urged anyone who used it and suffered from any adverse reactions to immediately seek medical help.

WHO

According to the alert, “WHO is not currently aware of any reports of adverse events following the use of this reported falsified DEFITELIO, however, the safety, sterility, and quality of the falsified products referenced in this alert are unknown”.

“If you, or someone you know, has or may have used the affected product, or suffered an adverse reaction or unexpected side-effect after use, you are advised to seek immediate medical advice from a healthcare professional.Healthcare professionals should report the incident to the National Regulatory Authorities/National Pharmacovigilance Centre. National regulatory/health authorities are advised to immediately notify WHO if they identify these falsified products,” read the WHO advisory.

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