WHO Warns of Falsified Versions of Cancer Drug Iclusig
The World Health Organization is warning regulators, industry and health care professionals to be on the lookout for falsified versions of Takeda and Incyte’s leukemia drug Iclusig (ponatinib).The announcement comes as on 15 January, WHO was informed by health authorities in Switzerland that a local wholesaler had purchased packs of the 15mg version of Iclusig and upon verification, the market authorization holder confirmed the packs as falsified. Further investigation confirmed that there are two versions of falsified Iclusig being traded globally, including via the internet.
Both the 15mg and 45mg versions highlighted by WHO were found to contain paracetamol.
Noting that this is an active investigation, Takeda told Focus in a statement: "We are in discussions and collaborating closely with our partner Incyte, who co-develops and commercializes Iclusig across Europe, to monitor and remedy the situation and to minimize any potential supply disruption to patients and healthcare professionals.
"Counterfeit batches of Iclusig originated from a Turkish wholesaler and were distributed to multiple regions, including Turkey, Switzerland and Argentina. At this time, no US product has been found to be counterfeit. We cannot predict if other countries or regions will be impacted, but we are working diligently to investigate the issue and minimize any potential supply disruption to patients and healthcare professionals."
Takeda and Incyte also confirmed to WHO that they did not manufacture or supply the products and that the batch numbers do not correspond to genuine manufacturing records.
“WHO requests increased vigilance within the supply chains of countries likely to be affected by these falsified products. Increased vigilance should include hospitals, clinics, health centres, wholesalers, distributors, pharmacies and any other suppliers of medical products,” the notice says.
The notice this month follows a previous notice last month in which WHO warned falsified rabies vaccines, known as Verorab, were identified in the Philippines. Sanofi Pasteur, the manufacturer of the legitimate product, confirmed to WHO that it did not manufacture these products and that the data on the packages do not correspond with actual company records.