The World Health Organisation (WHO) on Monday sounded an alert over detection of a fake batch of liver drug DEFITELIO (defibrotide sodium) detected in India and Turkiye. As per the WHO alert, the “falsified product” was detected in India in April 2023 and in Turkiye two months later in July. The fake drug was supplied outside of regulated and authorised channels, WHO added.
The drug Defitelio is given for treatment of severe hepatic veno-occlusive disease (VOD), also known as sinusoidal obstructive syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy, the international health body said. “It is indicated for adults, adolescents, children and infants over 1 month of age. VOD is a condition in which the veins in the liver become blocked and stop the liver working correctly,” the alert added.
The genuine manufacturer of the medicine has confirmed that the product referenced in the alert is falsified, WHO said. As per the manufacturer, the said lot of genuine DEFITELIO was packaged in German/Austrian packaging while the falsified products are in UK/Ireland packaging. It further advised that the expiry date mentioned is falsified and does not comply with the registered shelf life and the serial number stated is also not not associated with batch 20G20A of the genuine lot. The drug Defitelio does not have marketing authorization either in India or Turkiye.
Enumerating the risks attached with the falsified Defitelio, WHO said its usage can result in ineffective treatment and may pose serious health risks because of its intravenous nature of administration and could even be life-threatening in some circumstances.
