WHO Warns Against The Use Of DEFITELIO- A Fake Liver Drug

The WHO issued an alert against DEFITELIO (defibrotide) - a fake liver drug allegedly being sold in India and Turkey. 

“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 Türkiye (July 2023) and was supplied outside of regulated and authorized channels,” the alert issued by WHO said.The drug is employed to treat severe hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy. It is  prescribed to adults, adolescents, children and infants over one month of age. VOD causes the veins in the liver to get blocked and stops the organ from working correctly.

WHO corroborated with the genuine manufacturer of Defitelio, that has verified that the product referenced in the alert was a duplicate.

“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.” stated the manufacturer. 

WHO has issued an alert against the aforementioned drug before in May, 2020, when it found the fake drug for sale in countries like Argentina, Australia, Latvia, Malaysia and Saudi Arabia. 

The contested drug will not only prove the treatment to be ineffective but also pose serious health risks because of its intravenous administration, and could even be life-threatening in some cases, as notified in 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.

Although the health ministry was unavailable for a comment,  officials familiar with the issue said that the matter was being investigated, and it was too early to comment, as reported by HT. WHO has however, repeatedly warned medical practitioners and public about purchasing or using the drug. 

“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. WHO has also asked people who might have any information about the manufacture or supply of these products to contact WHO at rapidalert@who.int.lso. All drugs and other medical products should be bought from authorised and licensed suppliers, it added.