E-DRUG: Counterfeit Artesunate Warning Sheet
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Dear Colleagues,
Re: Seven 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 (Newton et al. 2001). On 10th June 2003 we disseminated a warning sheet, through e-drug, describing three generations of counterfeit artesunate, labelled as made by Guilin Pharma in the Peoples 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 (Newton et al. 2003). Dondorp et al. (2004) recently estimated that 53% of shop-bought artesunate in SE Asia was fake.
Since 2001, at least a further 4 types of counterfeit artesunate, based on the appearance of holograms affixed to blisterpacks, have appeared. A warning sheet describing these new holograms is available at the following websites:
http://www.jr2.ox.ac.uk/ndm/Tropical_Medicine/News.htm
http://www.cdc.gov/malaria/pdf/FakeArtesunateWarning_Jan2005.pdf
http://mosquito.who.int/docs/FakeArtesunateWarningJan2005.pdf
If you would like a CD of the Word 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 or newtonpaul100@yahoo.co.uk).
A Lao language version is available and versions in Burmese and Karen are also planned.
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 artesunate 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.
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
Arjen Dondorp
Michael D Green
Nicholas J White
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital,
Oxford OX3 7LJ, UK (PNN, AD & NJW)
U.S. Centers for Disease Control and Prevention, 1600 Clifton Road N.E.
Mailstop F12, Atlanta, GA 30333, USA (MDG)
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