Alert: Falsified DEFITELIO (defibrotide) Detected in Europe and South-East Asia

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Counterfeit DEFITELIO (defibrotide) discovered in WHO Regions spanning Europe and South-East Asia.

Alert Summary

The World Health Organization (WHO) has identified one falsified batch of DEFITELIO (defibrotide sodium) in the WHO Regions of Europe and South-East Asia. This falsified product was discovered in India (April 2023) and Türkiye (July 2023) and was distributed outside of authorized channels.

DEFITELIO (defibrotide) is a medication used to treat severe hepatic veno-occlusive disease (VOD), also known as sinusoidal obstructive syndrome (SOS), in hematopoietic stem-cell transplantation (HSCT) therapy. It is prescribed for adults, adolescents, children, and infants over 1 month of age. VOD is a condition in which the veins in the liver become blocked, impairing the liver’s normal function.

The genuine manufacturer of DEFITELIO has confirmed that the product mentioned in this alert is falsified. The manufacturer has provided the following information:

  • Genuine DEFITELIO with Lot 20G20A was packaged in German/Austrian packaging.
  • The falsified products are found in UK/Ireland packaging.
  • The stated expiry date is falsified and does not match the registered shelf life.
  • The stated serial number is not associated with batch 20G20A.
  • DEFITELIO does not have marketing authorization in India and Türkiye.

WHO has previously issued alerts regarding falsified DEFITELIO detected in other countries and regions. Please refer to Medical Product Alert N°5/2020 and Medical Product Alert N°3/2023 for more information.

Please see the Annex of this alert for comprehensive details of the affected products.

Risks

The use of falsified DEFITELIO can result in ineffective treatment of patients and may pose other serious health risks, especially due to its intravenous administration. In some cases, it could be life-threatening.

While WHO is not currently aware of any adverse events related to the use of this reported falsified DEFITELIO, the safety, sterility, and quality of the falsified products mentioned in this alert remain unknown.

Advice to Regulatory Authorities and the Public

If you possess any of the affected products, WHO strongly advises against their use. In case you, or someone you know, has used the affected product, or experienced any adverse reactions or unexpected side effects following its use, immediate medical advice from a healthcare professional is recommended.

Healthcare professionals are urged to report such incidents to the National Regulatory Authorities/National Pharmacovigilance Centre. National regulatory and health authorities are also advised to promptly notify WHO if they identify these falsified products.

All medical products must be obtained from authorized and licensed suppliers. If you have any information concerning the manufacturing or distribution of these products, please contact WHO via rapidalert@who.int.

Annex: Details of the Substandard Product Referenced in Alert N°7/2023

WHO Global Surveillance and Monitoring System for Substandard and Falsified Medical Products

For more information, please visit our website.
Email: rapidalert@who.int

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