According to the UN health body, the genuine manufacturer of DEFITELIO has confirmed that the product mentioned in the alert is counterfeit.

The World Health Organization (WHO) issued an alert on Monday regarding counterfeit DEFITELIO (defibrotide) being sold in India and Turkey.

The WHO states, “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.”

DEFITELIO is a drug used in haematopoietic stem-cell transplantation (HSCT) therapy to treat severe hepatic veno-occlusive disease (VOD) or sinusoidal obstructive syndrome (SOS). It is safe to use in adults, adolescents, children, and infants over the age of one month. VOD is a condition in which the veins of the liver become blocked, resulting in improper organ function.

“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 World Health Organization (WHO) has identified counterfeit DEFITELIO in countries like Argentina, Australia, Latvia, Malaysia, and Saudi Arabia, posing serious health risks due to its intravenous administration. Although no adverse events have been reported, the safety and quality of these counterfeits remain unknown.

The health ministry has not yet responded, but the government is investigating the matter. WHO advises medical practitioners and the public against using the product.

“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.