E-DRUG: Report of falsified parenteral artesunate
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Source: Guo S, Kyaw MP, He L, Min M, Ning X, Zhang W, Wang B, Cui L. Quality Testing of Artemisinin-Based Antimalarial Drugs in Myanmar. Am J Trop Med Hyg. 2017 Oct;97(4):1198-1203. doi: 10.4269/ajtmh.17-0305. https://www.ncbi.nlm.nih.gov/pubmed/28820713
The first public report of falsified parenteral artesunate has been published, within a paper describing quality testing of artemisinin-based medicines in Myanmar. The sample is stated as collected in Bago, Myanmar, labelled as 'Artesun’ 50mg artesunate for injection and labelled as made by Guilin Pharmaceutical Co., Ltd. with batch number LA131111. High performance liquid chromatography did not detect any artesunate within the sample and chemistry also suggested that the accompanying vial of '5% sodium bicarbonate’ did not contain bicarbonate.
As the authors state ‘Clinical trials in severe malaria, both adults and children, suggest that in comparison with quinine, parenteral artesunate reduces mortality by 34.7% and 22.5%, respectively, and is recommended as first-line therapy by WHO for severe malaria. With increasing use of this life-saving drug globally, the discovery of one sample of falsified parental artesunate has grave implications and strongly suggests that enhanced global monitoring of the quality of these products are urgently required.'
This posting is to alert the wider public health and malaria control communities of this finding out of concern that there are likely to be more falsified artesunate for injection elsewhere.
Paul Newton,
Infectious Diseases Data Observatory & MORU Tropical Health Network,
LOMWRU, Mahosot Hospital,
Vientiane, Lao PDR
Paul Newton <Paul.Newton@tropmedres.ac>