WHO warns of a spurious rare disease drug Defitelio floating in India

The WHO said that the genuine manufacturer of Defitelio has confirmed that the product referenced in the alert is falsified

The World Health Organization (WHO) on Monday issued an alert against a fake liver drug called Defitelio (defibrotide), which was reportedly being sold in India and Turkiye.

“This WHO medical product alert refers to one falsified batch of Defitelio (defibrotide sodium). This falsified product has been detected in India (April 2023) and Turkiye (July 2023) and was supplied outside of regulated and authorised channels,” the alert issued by WHO said.

The drug is indicated for the treatment of severe hepatic veno-occlusive disease (VOD), commonly known as sinusoidal obstructive syndrome (SOS), in haematopoietic stem-cell transplantation (HSCT) therapy. It is indicated for adults, adolescents, children and infants over one month. VOD is a condition in which the veins in the liver get blocked, preventing the organ from functioning normally.

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 authorisation in India and Turkiye.”

This is not the first WHO has issued an alert against the said drug. On May 7, 2020, the global health body found the fake drug being sold in Argentina, Australia, Latvia, Malaysia and Saudi Arabia.

The use of falsified Defitelio is likely to result in the ineffective treatment of patients. It may pose major health risks because of its intravenous administration and could be life-threatening in some circumstances, 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,” it said..

“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,” it added.

While all drugs and other medical products should be bought from authorised and licensed suppliers, WHO said that in case people have any information about the manufacture or supply of these products, WHO should be contacted at rapidalert@who.int.lso.