WHO alert on falsified and contaminated Defibrotide
Medical Product Alert N°5/2020
UPDATE (of 1 July 2020) to Medical Product Alert n°5/2020
This alert relates to falsified DEFIBROTIDE 200MG VIALS OF 2.5ML (80MG/ML) CONCENTRATE FOR SOLUTION FOR INFUSION identified to date in Argentina, Australia, Latvia, Malaysia and Saudi Arabia. This product is sold under the brand name Defitelio.
On 13 March 2020, the WHO Global Surveillance and Monitoring System on Substandard and Falsified (SF) Medical Products was informed that falsified DEFIBROTIDE 200MG vials were identified at patient level in Australia, displaying batch number 0286 (see Table 1 below for full details).
Following enquiries with stakeholders, on 8 April 2020, WHO was informed that falsified DEFIBROTIDE 200MG vials had also been supplied to Saudi Arabia, displaying batch number 0286 and 0126 (see Table 1 below for full details). On 9 April 2020, WHO was informed that falsified DEFIBROTIDE 200MG vials, displaying batch number 0126, had also been identified in Australia and Latvia.
As a result of the publication of Medical Product Alert n°5/2020 the WHO was informed falsified DEFIBROTIDE 200MG vials with batch number 0286 was supplied to Argentina. On 19 June WHO was informed the same falsified batch was supplied to Malaysia. 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.
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