The World Health Organisation (WHO) has issued a medical product alert today that falsified versions of ICLUSIG (Ponatinib) have been discovered in Turkey, Argentina and Switzerland, and in Internet sales. The falsified (counterfeit) medicines do not contain any of the CML drug ponatinib, but only low quantities of paracetamol. These falsified medicines are not going to have any effect against CML. The falsified English language packs contain the batch numbers
- PR072875 (UK/Ireland pack, English language, 60 tablets á 45mg, Expiry date 12/2019) and
- 25A19E09 (UK/Ireleand pack, English language, 30 tablets á 15mg, Expiry date 10/2020).
The WHO page which is available in English, French, Russian and Spanish provides photos of the packages and pill bottles so patients can find the batch numbers.
To identify falsified product batches both the batch number and packaging (language, country of the pack) are important.
No UK/Ireland ORIGINAL product has been produced by the manufacturers Incyte/Takeda that carries those batch numbers. – so products with the above two batch numbers in UK/Ireland and English language are most likely falsified. In case of PR072875, the counterfeiters used this genuine lot number originally issued on a German ICLUSIG box and created a falsified UK packaging.
And so far, the manufacturer and medicines authorities are NOT aware of additional FALSIFIED ponatinib products bearing different batch numbers, so patients taking Ponatinib with other batch numbers than those listed above should NOT yet be concerned.
Patients, physicians and distributors should make sure to obtain CML medication from validated and reliable sources that are able to demonstrate the authenticity of origin of the products.
In case of any concern, check the batch number against the two identified falsifications, and contact Incyte Medical Information in case of persisting suspicion at eumedinfo@incyte.com or +800 00027423.
Please let the CML Advocates Network know via info@cmladvocates.net if you come across the falsified product with these batch numbers, so we know whether the falsified medicines have been shipped to any other regions or countries. National CML patient groups are also encouraged to notify their local health authorities and leading physicians.
