This Medical Product Alert relates to confirmed falsified versions of ICLUSIG 45mg circulating in the WHO Region of the Western Pacific. This is linked to the WHO Medical Product Alert N°2/2019 issued on 31 January 2019 regarding falsified ICLUSIG traded globally. Genuine ICLUSIG, the active pharmaceutical ingredient of which is Ponatinib Hydrochloride, is used to treat different forms of leukaemia.
On 18 February 2019, WHO was informed that a wholesaler based in Malaysia had purchased the product ICLUSIG 45mg with batch number PR072875, presented in English language packaging. This specific product is referenced in the previous WHO Medical Product Alert N°2/2019 and is confirmed falsified.
The same wholesaler had also purchased ICLUSIG 45mg with batch number PR0834170, presented in German language packaging. Upon verification, the stated manufacturer confirmed that this specific product is also falsified.
Details of the two falsified products detected in Malaysia are summarized in the below table:
At this stage, laboratory analysis has not yet been conducted on the samples from Malaysia. Both products were made available at patient level.
Samples of the two falsified ICLUSIG products which are referenced in the previous WHO Medical Product Alert N°2/2019 have been analyzed (ICLUSIG 45mg with batch number PR072875 and ICLUSIG 15mg with batch number 25A19E09) . Both laboratory results show that the expected active ingredient, ponatinib, is absent, and, instead, paracetamol is present.
ICLUSIG is commercialized by different stakeholders in different parts of the world. The pharmaceutical companies TAKEDA and INCYTE are the genuine manufacturers of ICLUSIG and they have both confirmed to WHO that:
- They did not manufacture or supply the above products, and
- The batch number PR0834170 does not correspond to genuine manufacturing records;
- The batch number PR072875 combined with English language packaging does not correspond to genuine manufacturing records.
Photographs are available below.
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 centers, wholesalers, distributors, pharmacies and any other suppliers of medical products.
If you are in possession of the above products, please do not use. If you have taken this falsified product, or if you suffer an adverse event or an unexpected lack of efficacy, please seek immediate advice from a qualified healthcare professional, and ensure they report the incident to your local Ministry of Health/National Medicines Regulatory Authorities/National Pharmacovigilance Centre.
All medical products must be obtained from authentic and reliable sources. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of doubt.
National health authorities are asked to immediately notify WHO if these falsified products are discovered in their country. If you have any information concerning the manufacture, distribution, or supply of these products, please contact: rapidalert@who.int
Substandard and Falsified (SF) Medical ProductsAll WHO Drug Alerts are available at the following link:
https://www.who.int/teams/regulation-prequalification/incidents-and-SF/full-list-of-who-medical-product-alerts
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https://www.who.int/teams/regulation-prequalification/regulation-and-safety/rss