WHO Medical Product Alert UPDATE: Falsified Iclusig traded globally discovered now in Malaysia
UPDATE: Falsified Iclusig traded globally, discovered in Malaysia (new), Turkey, Switzerland, Argentina and Internet sales with UK/Ireland product batch numbers PR072875 (45mg) and 25A19E09 (15mg).
Dear CML Advocates Network members,
The World Health Organisation (WHO) has issued a medical product alert that falsified versions of ICLUSIG (Ponatinib) have been discovered in Turkey, Argentina and Switzerland, and in Internet sales. The falsified 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 lot/batch numbers.
PR072875 (UK/Ireland pack, English language, 60 tablets á 45mg, Expiry date 12/2019) and
25A19E09 (UK/Ireland pack, English language, 30 tablets á 15mg, Expiry date 10/2020).
In addition, on 20 February 2019, we were notified of a new falsified Iclusig pack:
PR0834170 (German pack, German language, 30 tablets á 45 mg, Expiry date 06/2020).
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. The WHO page has not yet been updated on the third falsified pack, which is expected those days but you can check the first Medical Product Alert information here:
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 in languages from those countries and with these languages. Products with the above batch numbers, country and 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. In case of 25A19E09 and PR0834170, no original products were manufactured wih those batch numbers.
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 firstname.lastname@example.org or +800 00027423.
Please let the CML Advocates Network know via email@example.com 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.
Thank you so much for your collaboration!Best regards,
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