WHO has released an alert relates to falsified DEFIBROTIDE 200MG VIALS OF 2.5ML (80MG/ML) CONCENTRATE FOR SOLUTION FOR INFUSION which is sold under the brand name Defitelio, identified in Australia, Latvia and Saudi Arabia.
DEFIBROTIDE is used to treat hepatic veno-occlusive disease, in which the blood vessels in the liver become damaged and obstructed by blood clots. This can be caused by treatments prior to a stem cell transplantation.
Laboratory analyses, conducted by national medicines regulatory authorities and the manufacturer of the genuine product, established that these falsified products do not contain any of the expected active ingredient. The solution in the vials is also contaminated with mould (Cladosporium sp. and Aspergillus niger).
Information available to WHO indicates that both batches of falsified DEFIBROTIDE 200MG vials were present within the regulated supply chain in Latvia as early as January 2020 and were also handled by medicine wholesalers in the United Kingdom in February 2020.
The genuine manufacturer of Defibrotide, GENTIUM S.R.L has also confirmed to WHO that:
- They did not manufacture the above products.
- Authentic DEFIBROTIDE 200MG VIALS with batch number 0286 were supplied to Argentina, Hong Kong, Malaysia, Singapore and Turkey.
- Authentic DEFIBROTIDE 200MG VIALS with batch number 0126 were supplied to Australia, Jordan, Kuwait, Lebanon, New Zealand, Qatar, Singapore, Turkey and the United Arab Emirates.
WHO alerted not to use these products, if anyone have used these falsified products, or suffer an adverse reaction/event having used these products, are advised to seek immediate medical advice from a qualified healthcare professional, and to report the incident to the National Regulatory Authorities/National Pharmacovigilance Centre. National regulatory/health authorities are advised to immediately notify WHO if these falsified products are identified in their country(ies).
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