WHO warns of falsified blood clot drug Defitelio

Falsified copies of Gentium’s antithrombotic medicine Defitelio have been discovered in United Arab Emirates and Kyrgyzstan, prompting an alert by the World Health Organisation (WHO).

The counterfeit batch of Defitelio (defibrotide sodium) – a drug used to treat severe clotting complications (veno-occlusive disease or VOD) in patients undergoing bone marrow transplant procedures – has been identified with UK/Ireland and US packaging.

VOD is a condition caused by high doses of chemotherapy and radiation therapy to prepare patients for a bone marrow transplant, in which the veins in the liver become blocked and stop the liver working properly.

It is life-threatening, with a mortality rate of 80% or more without treatment, and can lead to liver failure. That makes the falsification of Defitelio particularly despicable, as lab analyses revealed the fake medicine contained no active ingredient.

One study found that even with treatment with defibrotide or other therapies, children with VOD had a 38.5 per cent mortality rate 100 days after a transplant, compared to 9 per cent of those who did not develop the condition.

Aside from being ineffective, the counterfeit “may pose other serious risks to health because of its intravenous administration and could be life-threatening in some circumstances,” said the WHO in its alert.

The manufacturer has also confirmed that the batch number on some of the packs of the falsified product (19G19A) is not genuine and the expiry dates are also fake. A falsified US pack bearing batch number 19G19A and expiry date 01/2025 had a vial inside with a different batch number (M06B466E) which is also not genuine.