Medical Product Warning no. 3/2019 (English version)

Counterfeit ICLUSIG available at patient level in Asia and traded globally

Counterfeit ICLUSIG available at patient level in Asia and traded globally

This medical device alert applies to certified counterfeit versions of ICLUSIG 45 mg circulating in the WHO Western Pacific. This is related to WHO medical device alert no. 2/2019 issued on January 31, 2019 in connection with counterfeit ICLUSIG traded globally. The original ICLUSIG, whose active pharmaceutical ingredient is Ponatinib hydrochloride, is used to treat various forms of leukemia.

On 18 February 2019, WHO was informed that a Malaysian-based wholesaler had purchased the ICLUSIG 45mg product with serial number PR072875, presented in English packaging. This specific product is referenced in the previous one
WHO medical device alert no. 2/2019 and it was confirmed false.

The same wholesaler also purchased ICLUSIG 45mg with serial number PR0834170, presented in German-language packaging. After verification, the specified manufacturer confirmed that this particular product was also counterfeit.

The details of the two counterfeit products discovered in Malaysia are summarized in the table below:

At this stage, no laboratory analysis has been performed on samples from Malaysia. Both products were available at the patient level.

Samples of the two counterfeit ICLUSIG products mentioned above WHO medical device alert no. 2/2019 were analyzed (ICLUSIG 45 mg with serial number PR072875 and ICLUSIG 15 mg with serial number 25A19E09). Both laboratory results show that the expected active ingredient, ponatinib, is absent, and instead, paracetamol is present.

ICLUSIG has been commercialized by various stakeholders in different parts of the world. The pharmaceutical companies TAKEDA and INCYTE are the true producers of ICLUSIG and they have confirmed to WHO that:

• They did not manufacture or supply the above products, and
• Serial number PR0834170 does not match the original production records;
• The serial number PR072875 in combination with the English packaging does not match the original production information.

Photos are available below.

WHO requires greater vigilance in the supply chains of countries likely to be affected by these counterfeit products. Increased alertness should include hospitals, clinics, health centers, wholesalers, distributors, pharmacies and all other suppliers of medical devices.

If you own the above products, do not use them. If you have taken this counterfeit product or suffered an adverse event or unexpected lack of efficacy, seek the advice of a qualified healthcare professional immediately and ensure that they report the incident to your local Ministry of Health / National Medicines Regulatory Authority / National Pharmacovigilance Center.

All medical products must be obtained from credible and reliable sources. Their authenticity and condition should be carefully checked. If in doubt, seek the advice of a healthcare professional.

National health authorities ask you to notify WHO immediately if fake products are detected in their country. If you have any information on the production, distribution or supply of these products, please contact: [email protected]

Substandard and counterfeit (SF) medical products
All WHO drug notices are available at the following link: http://www.who.int/medicines/publications/drugalerts/en/

To sign up for WHO Medical Device Alerts, visit: http://www.who.int/about/licensing/rss/en/

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