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Medication-associated diethylene glycol mass poisoning: A review and discussion on the origin of contamination

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Abstract

Diethylene glycol (DEG), an extremely toxic chemical, has been implicated as the etiologic agent in at least 12 medication-associated mass poisonings over the last 70 years. Why DEG mass poisonings occur remains unclear. Most reports do not contain detailed reports of trace-back investigations into the etiology. The authors, therefore, conducted a systematic literature review on potential etiologies of these mass poisonings. The current available evidence suggests that substitution of DEG or DEG-containing compounds for pharmaceutical ingredients results from: (1) deception as to the true nature of certain ingredients by persons at some point in the pharmaceutical manufacturing process, and (2) failure to adhere to standardized quality control procedures in manufacturing pharmaceutical products intended for consumers. We discuss existing guidelines and new recommendations for prevention of these incidents.

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Acknowledgements

The authors would like to thank Rick Roswick, America's Regional Quality Assurance Manager (Chemicals) of Proctor and Gamble Chemicals, Rick Sturges, America's Technical Support Organization of Proctor and Gamble Chemicals and Dennis Walker, Chemicals Regulatory of Proctor and Gamble Chemicals.

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Authors and Affiliations

  1. Division of Environmental Hazards and Health Effects, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA

    Joshua G Schier, Carol S Rubin & Michael A McGeehin

  2. United States Food and Drug Administration, Rockville, MD, USA

    Dorothy Miller

  3. Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA

    Dana Barr

Authors
  1. Joshua G Schier
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  2. Carol S Rubin
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  3. Dorothy Miller
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  4. Dana Barr
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  5. Michael A McGeehin
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Corresponding author

Correspondence to Joshua G Schier.

Additional information

Diethylene glycol, an extremely toxic chemical, has caused at least 12 medication-associated mass poisonings. The authors explored the literature to learn of failures in the pharmaceutical industry and how to prevent them.

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Schier, J., Rubin, C., Miller, D. et al. Medication-associated diethylene glycol mass poisoning: A review and discussion on the origin of contamination. J Public Health Pol 30, 127–143 (2009). https://doi.org/10.1057/jphp.2009.2

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