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[e-drug] Counterfeit artesunate antimalarial tablets

E-drug: Counterfeit artesunate antimalarial tablets
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Dear Colleagues,

Re: Second and third 'generation' fake Guilin Pharma 'artesunate'
tablets

In the late 1990s counterfeits of artesunate, a vital life-saving
antimalarial drug, were discovered circulating in SE Asia. Up to 38%
of 'artesunate', labelled as manufactured by Guilin Pharma, People's
Republic of China, bought in pharmacies and shops in mainland SE
Asia contained no detectable artesunate. This has led to an
unquantified but inevitability high mortality and morbidity amongst
falciparum malaria patients in the region. The fakes described in 2001
were relatively easy to distinguish from the genuine product by the
appearance of the packaging and holograms. A simple, inexpensive
dye test allows one to reliably check the authenticity of artesunate
tablets.

We are now writing to warn of two further sophisticated 'generations'
of counterfeit 'artesunate', labelled as produced by Guilin Pharma,
bought in Laos and Cambodia with new, convincing and very well
crafted but fake holograms attached to the blisterpack.

'Pdf' files of documents warning of the recent discovery of
sophisticated counterfeit artesunate, with photographs of the different
holograms, and a description of the Fast-Red dye test, are available
from newtonpaul100@yahoo.co.uk or newtonpaul100@hotmail.com.
Pictures of the genuine and fake holograms are also posted on the
Shoklo Malaria Research Unit website (www.shoklo-org.com). 

The first generation fake 'hologram', described in 2000, is not a true
hologram but a sticker and easy to distinguish from the genuine
hologram. This is still in circulation. The second generation hologram
is a true hologram and only appears to differ from the genuine
hologram in the shape of mountain outline and the lack of the
microscopic legend 'Guilin Pharma' printed below the 'waves'. The
printing on the blisterpack is not clear. Three blisterpacks were
recently bought in southern Laos and one in NE Cambodia with this
second generation hologram. All have the same code, and
manufacture and expiry dates (details in pdf file). It is likely however
that artesunate with this second generation fake hologram has or will
be made with different dates and codes.

The third generation hologram has a mountain outline similar to the
genuine Guilin product but lacks the microscopic legend 'Guilin
Pharma' printed below the 'waves'. The printing on the blisterpack is
crisp and similar to that on the genuine product. Two blisterpacks
bearing this new hologram were recently bought in southern Laos (for
printed codes and dates see pdf file).

All six artesunate blisterpacks with the 2nd and 3rd generation fake
holograms were negative for artesunate by the Fast Red Dye Test
and contained no artesunate on HPLC analysis.

We fear that fake artesunate with the new sophisticated second and
third generation fake holograms are widely distributed but, because of
their similarity to the genuine product, that they are unrecognised by
pharmacists, health staff and patients. 

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 have heard that Guilin Pharma
artesunate is now sold in some west African countries, such as Togo,
and we are concerned that fakes may also be circulating. We would
be very grateful for information on this. 

There is an urgent need for action and we hope that this information
might prompt action to combat this under recognised serious public
health problem. 

Please contact us if you need any further information.

Very best wishes,

Paul Newton
Arjen Dondorp
Michael Green
Shunmay Yeung
Nicholas J White
 
References: 
1. Rozendaal J. Fake antimalarials circulating in Cambodia. Bull
Mekong Malaria Forum 2000; 7: 62-68.

2. Newton PN, Proux S, Green M, Smithuis F, Rozendaal J,
Prakongpan S, Chotivanich K, Mayxay M, Looareesuwan S, Farrar J,
Nosten F,White NJ. Fake artesunate in southeast Asia. Lancet 2001;
357: 1948-1950.

3. Green MD, Mount DL, Wirtz RA. Authentication of artemether,
artesunate and dihydroartemisinin antimalarial tablets using a simple
colorimetric method. Trop. Med. Int. Health 2001; 6: 980 - 982.
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