Late last week, the U.S. Food and Drug Administration issued a warning to healthcare professionals and drug manufacturers about the potential presence of diethylene glycol (DEG) in prescription and over-the-counter drugs. DEG is a known poison used in the production of antifreeze and it can be fatal if consumed by humans.
DEG is often added to glycerin as a cost-saving measure for counterfeiters; glycerin is a thick sweetener that is commonly used in liquid medications. “At the present time,†says the agency, “FDA has no reason to believe that the U.S. supply of glycerin is contaminated with DEG, though the agency is cognizant of reports from other countries over the past several years in which DEG-contaminated glycerin has caused human deaths. FDA is emphasizing the importance of testing glycerin for DEG due to the serious nature of this potentially fatal problem in combination with the global nature of the pharmaceutical supply chain and problems that continue to occur with this kind of contamination in some parts of the global supply of glycerin.â€
Most recently, an outbreak of DEG poisoning in Panama was traced to a batch of contaminated cough syrup, which led to more than 40 confirmed deaths and hundreds of illnesses–many estimates put those numbers even higher. Similar outbreaks were reported during the 1990s in Haiti, Argentina, Bangladesh, India, and Nigeria. In fact, a rash of DEG poisoning killed more than 100 people in the United States in 1937, a problem that led directly to the Federal Food, Drug, and Cosmetic Act and the creation of the U.S. Food and Drug Administration in the first place.
In all of the aforementioned cases, the FDA notes that “pharmaceutical manufacturers of the syrups that contained contaminated glycerin did not perform full identity testing on the glycerin raw material†and that the manufacturers only “relied on the certificate of analysis (COA) provided by the supplier.†In most cases, the COA documents were not accurate. According to the FDA’s most recent guidance on the matter, they are asking all manufacturers to conduct an “identity test†for DEG on all lots of glycerin and to be vigilant about ensuring the integrity of its supply chain.
This weekend, the New York Times ran a major story about diethylene glycol and its common use by drug counterfeiters. The Times’ investigation traced the source of the majority of DEG contamination to China. Although the FDA did not specifically mention China as a potential source of the problem, it appears that much of the contaminated glycerin originated there. As proved by the recent outbreak of melamine contamination in Chinese vegetable proteins, the Chinese government’s food- and drug-safety measures continue to fall short of the norm for the developed world.
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