| Fake artesunate in SE Asia: murder by counterfeit antimalarials | ||||||
Paul
Newton, Stephane Proux, Michael Green, Frank Smithius, Nguyen H Phu, Jan
Rozendaal, Sompon Prakongpan, Kesinee Chotivanich, Mayfong Mayxay, Francois
Nosten, and Nicholas White
Summary Background Artesunate is a key antimalarial drug in the treatment of multidrug resistant Plasmodium falciparum malaria in mainland SE Asia. The recent distribution of counterfeit artesunate tablets in the region has killed patients and caused great public health concern. Methods The characteristics of artesunate tablets and their packaging, bought in Burma (Myanmar), Cambodia, Viet Nam, Lao PDR and Thailand, were examined. Tablets were tested for authenticity using a validated, simple and inexpensive Fast Red TR dye technique and a subset were assayed using High Performance Liquid Chromatography. Findings Counterfeit artesunate tablets were found in all countries sampled but only the Guilin Pharmaceutical Co. product has so far been targeted. Of shop bought 'artesunate' 38 % of tablets did not contain the active drug. Tablet and packaging characteristics predicted reliably the authenticity of the tablets. Depending on the country concerned, cost, number of tablet faces with the 'AS' logo impressed, hologram appearance, blisterpack crimping and print clarity and tablet weight were identified as the most reliable markers of the counterfeit artesunate being distributed currently. Interpretation Counterfeit artesunate tablets are distributed widely and in large quantities in mainland SE Asia. This illicit trade is a great threat to the lives of patients with malaria and compromises malaria control efforts. Tablet and blisterpack characteristics can be used to reliably to distinguish genuine from fake tablets but these characteristics are likely to change in the future. The simple dye test will allow national malaria control authorities to detect counterfeit artesunate. Genuine Artesunate
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