E-DRUG: Fake Artesunate Warning Sheet 3rd edition
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[To respond directly to Paul, DO NOT CLICK REPLY. RESPOND TO <newtonpaul100@yahoo.co.uk>]
Dear Colleagues,
Re: Twelve different types of counterfeit artesunate tablets in SE Asia
In the late 1990s counterfeits of artesunate, a vital life-saving antimalarial drug, were discovered circulating in SE Asia. In 2000-2001, approximately 38% of shop-bought artesunate in mainland SE Asia was fake. In January 2005 we disseminated a warning sheet, through e-drug¹, describing
seven types¹ of counterfeit artesunate¹, labelled as made by Guilin Pharma¹ in the People¹s Republic of China, but which contained none of the active ingredient.
The prevalence of counterfeit artesunate in mainland SE Asia remains very high and may be increasing. Dondorp et al. (2004) recently estimated that 53% of shop-bought artesunate in SE Asia was fake.
Since January 2005, at least a further 5 types¹ of counterfeit artesunate, based on the appearance of stickers and holograms affixed to blisterpacks, have been described. A
warning sheet describing these new holograms is available at the following websites:
http://www.jr2.ox.ac.uk/ndm/Tropical_Medicine/News.htm
www.who.int/medicines/organization/qsm/activities/qualityassurance/cft/Fake_
Artesunate_Warning_25_08_2005.pdf
http://www.cdc.gov/malaria/travel/counterfeit_drugs.htm
If you would like a CD of the Word¹ file containing scans of the holograms and stickers, to use the pictures elsewhere, or to translate the sheet into another language please let us know (paul@tropmedres.ac).
The epidemic of fake artesunate is a severe public health problem in Asia and, with artesunate now being deployed in Africa, we fear that the counterfeits will follow in the footsteps of the genuine product. A Fast Red TR dye test is available for the rapid and inexpensive provisional
determination as to whether artesunate¹ tablets do contain artesunate (Green et al. 2000, 2001).
Please disseminate this information. If you find any similar fake artesunate we would be very grateful for the information - so that we can map the distribution and update this warning sheet.
We strongly urge greater action by governments and international organisations and we hope that this information might prompt vigorous action to combat this under-recognised and serious public health problem.
Please contact us if you would like any further information.
Very best wishes,
Paul N Newton
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital,
Oxford OX3 7LJ, UK
Paul <newtonpaul100@yahoo.co.uk>
References:
Dondorp AM, P N Newton, M Mayxay, W Van Damme, F M Smithuis, S Yeung, A
Petit, A J Lynam, A Johnson, T T Hien, R McGready, J J Farrar, S Looareesuwan, N P J Day, M D Green, N J White (2004) Fake antimalarials in Southeast Asia are a major impediment to malaria control: multinational cross-sectional survey on the prevalence of fake antimalarials. Trop Med Int Hlth 9, 1241-1246.
Green MD, Mount DL, Wirtz RA, White NJ (2000) A colorimetric field method to assess the authenticity of drugs sold as the antimalarial artesunate.
Journal of Pharmaceutical and Biomedical Analysis 24, 65-70.
Green MD, Mount DL, Wirtz RA (2001) Authentication of artemether, artesunate and dihydroartemisinin antimalarial tablets using a simple colorimetric method. Trop Med Int Hlth 6, 980 - 982.
Newton PN, Proux S, Green M, Smithuis F, Rozendaal J, Prakongpan S, Chotivanich K, Mayxay M, Looareesuwan S, Farrar J, Nosten F,White NJ (2001) Fake artesunate in southeast Asia. Lancet 357, 1948-1950.
Newton PN, Dondorp A, Green M, Mayxay M, White NJ (2003) Counterfeit artesunate antimalarials in SE Asia. Lancet 362, 169