WHO warns against counterfeit medicine for circulating leukemia in Argentina – 02/12/2019

The World Health Organization (WHO) has launched a global alert for the commercialization of Falsified versions of a drug for the treatment of different types of leukemia that, instead of the active ingredient Ponatinib hydrochloride, contains low dose ibuprofen. Argentina is one of the countries in which the circulation of these products has been detected.

The alarm was sounded in the middle of last month by the Swiss health authorities who informed WHO that a wholesaler had bought boxes of Iclusig (trade name of the drug) and that the licensee market had confirmed that the containers were counterfeitas indicated in the alert issued on January 31st.

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The surveys, according to the report, revealed that there are two versions of the falsified drug being processed. "Worldwide marketing, including through Internet sales". One is the vial of 30 tablets of ICLUSIG 45 mg., The declared manufacturer is Incyte Biosciences, number of lot PR072875, with expiry date 12/2019. The other lot appears under the number 25A19E09, is 60 tablets of 15 mg, with an expiry date of 10/2020 and declares ARIAD Pharma Ltd. as a manufacturer. The labels in both cases are in English.

Laboratory tests carried out on lot 25A19E09 confirmed that the product "Does not contain ponatinib, but small amounts of paracetamol". Although the badysis of PR072875 is not complete at the time of publication of the alert message, preliminary results indicate that it does not contain ponatinib, the expected active ingredient.

A statement issued by Incyte – one of the manufacturers of the drug and the licensee to market it, like Takeda – confirmed that the research done by the laboratory and by the WHO had verified the marketing counterfeit medicines in Europe. Argentina, Turkey and Switzerlandand through Internet sales. The export of illegitimate products would have been carried out through a pharmacy of Turkish origin throughout Europe and part of Latin America.

On consultation with ClarinANMAT (National Administration of Medicines and Medical Technologies) reported that since the marketing authorization of the drug in the country, only two batches had been included, which were not included in the WHO alert. However, he said that by November 2018, he could only enter the country for private patients, without marketing purpose. Among these units, "ANMAT had detected an alert-related case and is monitoring the situation of the remaining products, to check if they could be related to the notification. "

In Argentina, Iclusig is marketed by Pint Pharma. Catalysis (your local representative) points out that "None of the lots involved have been imported and distributed by the laboratory". And he clarified that up to now the legitimate lots entered in the country are CBCTX and ZFNC; and that the CBPVH is being imported.

"This dangerous criminal behavior is alerting us," said Graciela Mosqueda, medical director of the company's oncology department for the Southern Cone, while emphasizing the importance of buying the product through the recognized and official trading channels. And he asked "to refrain from buying on sites of dubious origin".

"The simple fact that it is circulating [es una preocupación]. We do not know how many there are, we do not know what quantities exist; There are wholesalers who can act unscrupulously and that is how you can get into the system. Everyone should pay attention to the fact that this information is outstanding, "said Michael Deats, head of the fake drugs surveillance group at the WHO in Geneva, at the British newspaper The Guardian.

Ponatinib is the most recent therapeutic alternative approved by ANMAT for patients with chronic myeloid leukemia (in its chronic, accelerated, explosive crisis phases) and Acute lymphoblastic leukemia with Philadelphia chromosome positive (Ph + ALL) resistant to the first, second and even third line of treatment. In addition, it has been indicated in patients with the T315I mutation that, until admission of this novelty, they had no alternative treatment except bone marrow transplantation.

It's an expensive drug: the price of a bottle of 30 15 mg tablets is $ 1,076,078 and the price of 45 mg of $ 1,614,117.

WHO is seeking hospitals, clinics, health centers, wholesalers, distributors, pharmacies and other medical suppliers from countries likely to be affected by counterfeit products increase alertness in the supply chains. If you have accessed falsified units, please do not use them and encourage them to consult with health professionals. Inform the national health authorities if you have an adverse reaction or wish to check the unexpected effectiveness of the product.

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