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-
1
Hien TT, Day NP, Nguyen HP, Nguyen TH, Pham PL, Dinh XS, Ly VC, Ha V, Waller D, Peto TE, White NJ, 1996. A controlled trial of artemether or quinine in Vietnamese adults with severe falciparum malaria. N Engl J Med 335 :76–83.
-
2
Van Hensbroek MB, Onyiorah E, Jaffer S, Schneider G, Palmer A, Frenkel J, Enwere G, Forck S, Nusmeijer A, Bennett S, Greenwood B, Kwiatkowski D, 1996. A trial of artemether or quinine in children with cerebral malaria. N Engl J Med 335 :69–75.
-
3
Artemether–Quinine Meta-Analysis Study Group, 2001. A meta-analysis using individual patient data of trials comparing artemether with quinine in the treatment of severe falciparum malaria. Trans R Soc Trop Med Hyg 95 :637–650.
-
4
Dondorp A, Nosten F, Stepniewska K, Day N, White N, South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT) Group, 2005. Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial. Lancet 366 :717–725.
-
5
Silamut K, Newton PN, Teja-Isavadharm P, Suputtamongkol Y, Siriyanonda D, Rasameesoraj M, Pukrittayakamee S, White NJ, 2003. Comparison of antimalarial bioavailability after oral and intramuscular artemether administration in uncomplicated falciparum malaria. Antimicrob Agents Chemother 47 :3795–3798.
-
6
Hien TT, Davis TM, Chuong LV, Ilett KF, Sinh DX, Phu NH, Agus C, Chiswell GM, White NJ, Farrar J, 2004. Comparative pharmacokinetics of intramuscular artesunate and artemether in patients with severe falciparum malaria. Antimicrob Agents Chemother 48 :4234–4239.
-
7
Mayxay M, Nair S, Sudimack D, Imwong M, Tanomsing N, Pongvongsa T, Phompida S, Phetsouvanh R, White NJ, Anderson TJC, Newton PN, 2007. Combined molecular and clinical assessment of Plasmodium falciparum antimalarial drug resistance in the Lao People’s Democratic Republic (Laos). Am J Trop Med Hyg 76 :245–250.
-
8
Newton PN, Green MD, Fernández FM, Day NP, White NJ, 2006. Counterfeit anti-infective medicines. Lancet Infect Dis 6 :602–613.
-
9
Newton PN, McGready R, Fernandez F, Green MD, Sunjio M, Bruneton C, Phanouvong S, Millet P, Whitty CJ, Talisuna AO, Proux S, Christophel EM, Malenga G, Singhasivanon P, Bojang K, Kaur H, Palmer K, Day NP, Greenwood BM, Nosten F, White NJ, 2006. Manslaughter by fake artesunate in Asia—Will Africa be next? PLoS Med 3 :e197.
-
10
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.
-
11
Lon CT, Tsuyuoka R, Phanouvong S, Nivanna N, Socheat D, Sokhan C, Blum N, Christophel EM, Smine A, 2006. Counterfeit and substandard antimalarial drugs in Cambodia. Trans R Soc Trop Med Hyg 100 :1019–1024.
-
12
Carpenter J, 2004. A Matrix of Drug Quality Reports on USAID-Assisted Countries by the USP Drug Quality and Information Program. Available at: http://www.uspdqi.org/pubs/other/GHC-DrugQualityMatrix.pdf. Accessed December 9, 2005.
-
13
Anonymous, 2001. Announcement on fake (imitation) drugs. The New Light of Myanmar, Volume IX, Number 204, November 9, 2001. Available at: http://www.myanmar.gov.mm/NLM-2001/enlm/Novem9.htm#(7).
-
14
Atemnkeng MA, De Cock K, Plaizier-Vercammen J, 2007. Quality control of active ingredients in artemisinin-derivative anti-malarials within Kenya and DR Congo. Trop Med Int Health 12 :68–74.
-
15
Mayxay M, Berends M, Brockman A, Jaidee A, Nair S, Sudimack D, Pongvongsa T, Phompida S, Phetsouvanh R, Anderson TJC, White NJ, Newton PN, 2007. In vitro antimalarial drug susceptibility and pfcrt mutation among fresh Plasmodium falciparum isolates from the Lao PDR (Laos). Am J Trop Med Hyg 76 :245–250.
-
16
Nyadong L, Green MD, De Jesus VR, Newton PN, Fernandez FM, 2007. Reactive desorption electrospray linear ion trap mass spectrometry of last-generation counterfeit antimalarials via noncovalent complex formation. Anal Chem 79 :2150–2157.
-
17
World Health Organisation, 2006. WHO Guidelines for the Treatment of Malaria. Geneva: WHO. Available at: http://www.who.int/malaria/docs/TreatmentGuidelines2006.pdf. Accessed January 26, 2008.
-
18
Jackson Y, Chappuis F, Loutan L, Taylor W, 2006. Malaria treatment failures after artemisinin-based therapy in three expatriates: could improved manufacturer information help to decrease the risk of treatment failure? Mal J 5 :81.
-
19
Kachur SP, Black C, Abdulla S, Goodman C, 2006. Putting the genie back in the bottle? Availability and presentation of oral artemisinin compounds at retail pharmacies in urban Dar-es-Salaam. Mal J 5 :25.
-
20
Looareesuwan S, Oosterhuis B, Schilizzi BM, Sollie FA, Wilairatana P, Krudsood S, Lugt Ch B, Peeters PA, Peggins JO, 2002. Dose-finding and efficacy study for i.m. artemotil (β-arteether) and comparison with i.m. artemether in acute uncomplicated P. falciparum malaria. Br J Clin Pharmacol 53 :492–500.
-
21
Lao PDR Ministry of Health, 2005. The Manual of Uncomplicated Malaria Diagnosis and Treatment Using Combination Regimens for Provincial and District Health Staff. Published by MoH, CMPE and Global Fund to fight AIDS, Tuberculosis and Malaria. Vientiane, Lao PDR: Ministry of Health, Government of the Lao PDR (in Lao).
-
22
Basco LK, Ringwald P, Manene AB, Chandenier J, 1997. False chloroquine resistance in Africa. Lancet 350 :224.
-
23
Taylor RB, Shakoor O, Behrens RH, 1995. Drug quality, a contributor to drug resistance? Lancet 346 :122.
-
24
Rozendaal J, 2000. Fake antimalarials circulating in Cambodia. Mekong Malaria Forum 7 :62–69.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 462 | 426 | 13 |
| Full Text Views | 271 | 5 | 1 |
| PDF Downloads | 88 | 5 | 1 |
Impaired Clinical Response in a Patient with Uncomplicated Falciparum Malaria Who Received Poor-Quality and Underdosed Intramuscular Artemether
Valy Keoluangkhot
Valy Keoluangkhot
Adult Infectious Disease Ward, Mahosot Hospital, Vientiane, Lao PDR; Wellcome Trust–Mahosot Hospital–Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR; Francophone Institute for Tropical Medicine, Vientiane, Lao PDR; Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Department of Post Graduate and Research, University of Health Sciences, Vientiane, Lao PDR; Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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Michael D. Green
Michael D. Green
Adult Infectious Disease Ward, Mahosot Hospital, Vientiane, Lao PDR; Wellcome Trust–Mahosot Hospital–Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR; Francophone Institute for Tropical Medicine, Vientiane, Lao PDR; Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Department of Post Graduate and Research, University of Health Sciences, Vientiane, Lao PDR; Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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Leonard Nyadong
Leonard Nyadong
Adult Infectious Disease Ward, Mahosot Hospital, Vientiane, Lao PDR; Wellcome Trust–Mahosot Hospital–Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR; Francophone Institute for Tropical Medicine, Vientiane, Lao PDR; Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Department of Post Graduate and Research, University of Health Sciences, Vientiane, Lao PDR; Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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Facundo M. Fernández
Facundo M. Fernández
Adult Infectious Disease Ward, Mahosot Hospital, Vientiane, Lao PDR; Wellcome Trust–Mahosot Hospital–Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR; Francophone Institute for Tropical Medicine, Vientiane, Lao PDR; Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Department of Post Graduate and Research, University of Health Sciences, Vientiane, Lao PDR; Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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Mayfong Mayxay
Mayfong Mayxay
Adult Infectious Disease Ward, Mahosot Hospital, Vientiane, Lao PDR; Wellcome Trust–Mahosot Hospital–Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR; Francophone Institute for Tropical Medicine, Vientiane, Lao PDR; Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Department of Post Graduate and Research, University of Health Sciences, Vientiane, Lao PDR; Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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Paul N. Newton
Paul N. Newton
Adult Infectious Disease Ward, Mahosot Hospital, Vientiane, Lao PDR; Wellcome Trust–Mahosot Hospital–Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR; Francophone Institute for Tropical Medicine, Vientiane, Lao PDR; Division of Parasitic Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia; School of Chemistry and Biochemistry, Georgia Institute of Technology, Atlanta, Georgia; Department of Post Graduate and Research, University of Health Sciences, Vientiane, Lao PDR; Centre for Tropical Medicine, Nuffield Department of Clinical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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We describe an adult with uncomplicated Plasmodium falciparum malaria who did not improve clinically despite 5 days of intramuscular artemether therapy. He was prescribed a lower dose (kg body weight) than that recommended, and a vial from the packet contained only 74% of the artemether dose as stated by the manufacturer. The combination of underdosing, poor-quality drug, and the intrinsic low bioavailability of artemether may have contributed to his poor clinical response. Analysis of the packaging and chemical “fingerprinting” of the artemether suggested that the drug was genuine but was either substandard or had deteriorated after manufacture.
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-
1
Hien TT, Day NP, Nguyen HP, Nguyen TH, Pham PL, Dinh XS, Ly VC, Ha V, Waller D, Peto TE, White NJ, 1996. A controlled trial of artemether or quinine in Vietnamese adults with severe falciparum malaria. N Engl J Med 335 :76–83.
-
2
Van Hensbroek MB, Onyiorah E, Jaffer S, Schneider G, Palmer A, Frenkel J, Enwere G, Forck S, Nusmeijer A, Bennett S, Greenwood B, Kwiatkowski D, 1996. A trial of artemether or quinine in children with cerebral malaria. N Engl J Med 335 :69–75.
-
3
Artemether–Quinine Meta-Analysis Study Group, 2001. A meta-analysis using individual patient data of trials comparing artemether with quinine in the treatment of severe falciparum malaria. Trans R Soc Trop Med Hyg 95 :637–650.
-
4
Dondorp A, Nosten F, Stepniewska K, Day N, White N, South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT) Group, 2005. Artesunate versus quinine for treatment of severe falciparum malaria: a randomised trial. Lancet 366 :717–725.
-
5
Silamut K, Newton PN, Teja-Isavadharm P, Suputtamongkol Y, Siriyanonda D, Rasameesoraj M, Pukrittayakamee S, White NJ, 2003. Comparison of antimalarial bioavailability after oral and intramuscular artemether administration in uncomplicated falciparum malaria. Antimicrob Agents Chemother 47 :3795–3798.
-
6
Hien TT, Davis TM, Chuong LV, Ilett KF, Sinh DX, Phu NH, Agus C, Chiswell GM, White NJ, Farrar J, 2004. Comparative pharmacokinetics of intramuscular artesunate and artemether in patients with severe falciparum malaria. Antimicrob Agents Chemother 48 :4234–4239.
-
7
Mayxay M, Nair S, Sudimack D, Imwong M, Tanomsing N, Pongvongsa T, Phompida S, Phetsouvanh R, White NJ, Anderson TJC, Newton PN, 2007. Combined molecular and clinical assessment of Plasmodium falciparum antimalarial drug resistance in the Lao People’s Democratic Republic (Laos). Am J Trop Med Hyg 76 :245–250.
-
8
Newton PN, Green MD, Fernández FM, Day NP, White NJ, 2006. Counterfeit anti-infective medicines. Lancet Infect Dis 6 :602–613.
-
9
Newton PN, McGready R, Fernandez F, Green MD, Sunjio M, Bruneton C, Phanouvong S, Millet P, Whitty CJ, Talisuna AO, Proux S, Christophel EM, Malenga G, Singhasivanon P, Bojang K, Kaur H, Palmer K, Day NP, Greenwood BM, Nosten F, White NJ, 2006. Manslaughter by fake artesunate in Asia—Will Africa be next? PLoS Med 3 :e197.
-
10
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.
-
11
Lon CT, Tsuyuoka R, Phanouvong S, Nivanna N, Socheat D, Sokhan C, Blum N, Christophel EM, Smine A, 2006. Counterfeit and substandard antimalarial drugs in Cambodia. Trans R Soc Trop Med Hyg 100 :1019–1024.
-
12
Carpenter J, 2004. A Matrix of Drug Quality Reports on USAID-Assisted Countries by the USP Drug Quality and Information Program. Available at: http://www.uspdqi.org/pubs/other/GHC-DrugQualityMatrix.pdf. Accessed December 9, 2005.
-
13
Anonymous, 2001. Announcement on fake (imitation) drugs. The New Light of Myanmar, Volume IX, Number 204, November 9, 2001. Available at: http://www.myanmar.gov.mm/NLM-2001/enlm/Novem9.htm#(7).
-
14
Atemnkeng MA, De Cock K, Plaizier-Vercammen J, 2007. Quality control of active ingredients in artemisinin-derivative anti-malarials within Kenya and DR Congo. Trop Med Int Health 12 :68–74.
-
15
Mayxay M, Berends M, Brockman A, Jaidee A, Nair S, Sudimack D, Pongvongsa T, Phompida S, Phetsouvanh R, Anderson TJC, White NJ, Newton PN, 2007. In vitro antimalarial drug susceptibility and pfcrt mutation among fresh Plasmodium falciparum isolates from the Lao PDR (Laos). Am J Trop Med Hyg 76 :245–250.
-
16
Nyadong L, Green MD, De Jesus VR, Newton PN, Fernandez FM, 2007. Reactive desorption electrospray linear ion trap mass spectrometry of last-generation counterfeit antimalarials via noncovalent complex formation. Anal Chem 79 :2150–2157.
-
17
World Health Organisation, 2006. WHO Guidelines for the Treatment of Malaria. Geneva: WHO. Available at: http://www.who.int/malaria/docs/TreatmentGuidelines2006.pdf. Accessed January 26, 2008.
-
18
Jackson Y, Chappuis F, Loutan L, Taylor W, 2006. Malaria treatment failures after artemisinin-based therapy in three expatriates: could improved manufacturer information help to decrease the risk of treatment failure? Mal J 5 :81.
-
19
Kachur SP, Black C, Abdulla S, Goodman C, 2006. Putting the genie back in the bottle? Availability and presentation of oral artemisinin compounds at retail pharmacies in urban Dar-es-Salaam. Mal J 5 :25.
-
20
Looareesuwan S, Oosterhuis B, Schilizzi BM, Sollie FA, Wilairatana P, Krudsood S, Lugt Ch B, Peeters PA, Peggins JO, 2002. Dose-finding and efficacy study for i.m. artemotil (β-arteether) and comparison with i.m. artemether in acute uncomplicated P. falciparum malaria. Br J Clin Pharmacol 53 :492–500.
-
21
Lao PDR Ministry of Health, 2005. The Manual of Uncomplicated Malaria Diagnosis and Treatment Using Combination Regimens for Provincial and District Health Staff. Published by MoH, CMPE and Global Fund to fight AIDS, Tuberculosis and Malaria. Vientiane, Lao PDR: Ministry of Health, Government of the Lao PDR (in Lao).
-
22
Basco LK, Ringwald P, Manene AB, Chandenier J, 1997. False chloroquine resistance in Africa. Lancet 350 :224.
-
23
Taylor RB, Shakoor O, Behrens RH, 1995. Drug quality, a contributor to drug resistance? Lancet 346 :122.
-
24
Rozendaal J, 2000. Fake antimalarials circulating in Cambodia. Mekong Malaria Forum 7 :62–69.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 462 | 426 | 13 |
| Full Text Views | 271 | 5 | 1 |
| PDF Downloads | 88 | 5 | 1 |