Fatal renal failure caused by diethylene glycol in paracetamol elixir: the Bangladesh epidemic

Hanif, Mohammed; Mobarak, Mohamed; Ronan, Anne; Rahman, Dr. Md. Anisur; Donovan, JL; Bennish, Michael L.

doi:10.1136/bmj.311.6997.88

Cited by 132 publications

(91 citation statements)

References 7 publications

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“…Sample 980201, which was collected in Ho Chi Minh City, also had no fake sticker/hologram (type 1), but bore atypically large printing font on the blisterpack and a simple chemical fingerprint that partially resembled the fingerprint from Vietnam sample 29, which was affixed with a type 2 fake foil sticker. These two samples contained CaCO 3 and might have been produced by the same manufacturing source, which added a fake foil sticker to its product in response to increased quality assurance measures put in practice by the genuine manufacturer.…”

Section: Multivariate Clustering Of Lc-ms Chemical Fingerprintsmentioning

confidence: 99%

“…For example, in Haiti, India, Nigeria, and Bangladesh some 500 children died of acute renal failure after ingesting counterfeit paracetamol (acetaminophen) and cough syrup made using diethylene glycol, a renal toxin. 2,3 Although there are few accurate estimates of the scale of the problem, only a few counterfeit drug incidents are reported to the appropriate enforcement agencies; thus, numbers of those affected by counterfeit drugs are likely to be grossly underestimated. 4,5 Since the late 1990s, counterfeit drugs manufactured to mimic antimalarial medicines have been detected in increasing numbers.…”

Section: Introductionmentioning

confidence: 99%

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Characterization of Counterfeit Artesunate Antimalarial Tablets From Southeast Asia

Hall

Newton²,

Green³

et al. 2006

The American Journal of Tropical Medicine and Hygiene

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Abstract. In southeast Asia, the widespread high prevalence of counterfeits tablets of the vital antimalarial artesunate is of great public health concern. To assess the seriousness of this problem, we quantified the amount of active ingredient present in artesunate tablets by liquid chromatography coupled to mass spectrometry. This method, in conjunction with analysis of the packaging, classified tablets as genuine, substandard, or fake and validated results of the colorimetric Fast Red TR test. Eight (35%) of 23 fake artesunate samples contained the wrong active ingredients, which were identified as different erythromycins and paracetamol. Raman spectroscopy identified calcium carbonate as an excipient in 9 (39%) of 23 fake samples. Multivariate unsupervised pattern recognition results indicated two major clusters of artesunate counterfeits, those with counterfeit foil stickers and containing calcium carbonate, erythromycin, and paracetamol, and those with counterfeit holograms and containing starch but without evidence of erythromycin or paracetamol.

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Section: Multivariate Clustering Of Lc-ms Chemical Fingerprintsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Characterization of Counterfeit Artesunate Antimalarial Tablets From Southeast Asia

Hall

Newton²,

Green³

et al. 2006

The American Journal of Tropical Medicine and Hygiene

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“…ounterfeit and substandard drugs are an emerging menace (1)(2)(3)(4)(5)(6)(7)(8)(9). Antimicrobials, especially antibiotics and antimalarial agents, are most often reported as substandard/counterfeit in lessdeveloped countries (10)(11)(12)(13)(14).…”

mentioning

confidence: 99%

Substandard/Counterfeit Antimicrobial Drugs

2015

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SUMMARY Substandard/counterfeit antimicrobial drugs are a growing global problem. The most common substandard/counterfeit antimicrobials include beta-lactams (among antibiotics) and chloroquine and artemisin derivatives (among antimalarials). The most common type of substandard/counterfeit antimicrobial drugs have a reduced amount of the active drug, and the majority of them are manufactured in Southeast Asia and Africa. Counterfeit antimicrobial drugs may cause increased mortality and morbidity and pose a danger to patients. Here we review the literature with regard to the issue of substandard/counterfeit antimicrobials and describe the prevalence of this problem, the different types of substandard/counterfeit antimicrobial drugs, and the consequences for the individuals and global public health. Local, national, and international initiatives are required to combat this very important public health issue.

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“…For example, paracetamol syrup, adulterated with diethylene glycol in the formulation, manufactured by small-scale pharmaceutical companies killed 339 children in 1992 and 27 children in 2009 in Bangladesh (The Guandian, 2009;The Daily Star, 2009;Hanif et al, 2005). Besides, under dosing of drugs may cause drug-resistance (Caudron et al, 2008;Taylor et al, 2001).…”

Section: Discussionmentioning

confidence: 99%

Evaluation of the Pharmaceutical Quality of Different Brands of Ranitidine Tablets Manufactured in Bangladesh: A Pharmaceutical and Public Health Prospective

et al. 2016

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Drug counterfeiting and production of substandard drug is a global problem. Substandard or counterfeit drugs are threat for the effective treatment of diseases and highly worsen the quality of life of patients. This study was aimed to assess the pharmaceutical quality of ranitidine hydrochloride tablets manufactured in Bangladesh. Tablets were collected from different parts of Bangladesh and quality parameters were evaluated according to the United States Pharmacopoeia and the British Pharmacopoeial methods. The potency of tablets was measured spectrophotometrically. Weight variation and disintegration time were performed according to pharmaceutical monographs. Among 43 brands tested, 8 failed to comply with the USP specification (active ingredient: 90±10%) due to containing of less amount of ranitidine of which 6 brands were spurious and 2 were substandard in nature. Two brands did not comply with the specification for weight variation of tablets whereas all brands passed disintegration time test. The findings clearly demonstrate the production of substandard ranitidine tablets in Bangladesh. The drug control authority of Bangladesh should take effective steps to prevent the production of substandard drugs to secure public health.

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Fatal renal failure caused by diethylene glycol in paracetamol elixir: the Bangladesh epidemic

Abstract: improved postatal growth. This may help to reduce the high infant mortality suffered by Asian groups.

Cited by 132 publications

References 7 publications

Characterization of Counterfeit Artesunate Antimalarial Tablets From Southeast Asia

Characterization of Counterfeit Artesunate Antimalarial Tablets From Southeast Asia

Substandard/Counterfeit Antimicrobial Drugs

Evaluation of the Pharmaceutical Quality of Different Brands of Ranitidine Tablets Manufactured in Bangladesh: A Pharmaceutical and Public Health Prospective

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