Diethylene glycol in over-the-counter health products imported from China and other Asian countries
Schier, J. G., Barr, D. B., Li, Z., Wolkin, A. F., Baker, S. E., Lewis, L. S., & McGeehin, M. A. (2010). Diethylene glycol in over-the-counter health products imported from China and other Asian countries. In , pp. 626–626. .
Background: Diethylene glycol (DEG) has been implicated in many medication-associated mass poisonings (MPs). If ingested, it can result in renal and neurological toxicity. Three previous MPs implicated China as the origin of contaminated ingredients. No literature exists on potential DEG or triethylene glycol (TEG), a related compound, contamination of health products imported from Asian countries to the United States (US). Our primary objective was to quantitatively assess the amount of DEG present in a convenience sampling of these health products. Secondary objectives were to: 1) assess the amount of TEG in samples if present; 2) compare results directly to DEG and TEG levels in medications implicated in previous similar MPs; 3) compare DEG results to the US Pharmacopeia's limits of DEG contamination in different monographs such as glycerin; and 4) to estimate DEG dose based on the manufacturer's instructions and compare values to past toxic and non-toxic doses.?Methods:?A quantitative assessment of DEG and TEG was performed in a convenience sampling of over-the-counter health products imported from Asian countries. Results were converted to volume to volume (v/v) % and compared to DEG levels in medications implicated in previous MPs and to the threshold for permissible DEG contamination of pharmaceutical ingredients such as glycerin. Estimated doses of each product for a 70 kg adult were compared to toxic doses of DEG reported in the literature.?Results:?Fifteen of 85 (18%) samples had detectable levels of DEG [mean, 18.8 ?g/mL; range, 0.791–110.1 ?g/mL; and volume to volume (v/v) range, 0.00007–0.01%]. Two of 85 (2%) samples had TEG levels of 12.8 and 20.2 ?g/mL or 0.0012 and 0.0018% TEG (v/v). The product with the highest DEG % by (v/v) was 810 times less than the Panama DEG mass poisoning (8.1%). All samples were at least 10 times lower than the maximum threshold for DEG contamination of glycerin. The lowest reported toxic dose from a past DEG mass poisoning (14 mg/kg) was more than 150 times higher than the highest daily dose estimated in our study (0.09 mg/kg).?Conclusion: DEG and TEG were detectable in 15/85 and 2/85 product samples. These levels probably do not represent an acute public health threat.