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FDA Warning: DEG-Contaminated Glycerin Remains Potential Health Hazard
Yael Waknine 

May 8, 2007 Healthcare professionals and others who compound medications using glycerin are being reminded of the importance of testing for diethylene glycol (DEG) contamination before use, the US Food and Drug Administration (FDA) warned yesterday. DEG, a solvent, is a known poison used in antifreeze.

Although the US supply of glycerin is not known to contain DEG, contaminated glycerin is known to have caused deaths in other countries over the past several years, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse-event reporting program.

The most recent incident was reported in Panama in September 2006; dozens of hospitalizations and more than 40 deaths were attributed to DEG-contaminated glycerin used to sweeten cough syrup. In late 1995 and early 1996, at least 80 pediatric deaths in Haiti were linked to DEG-contaminated glycerin in acetaminophen syrup. Similar incidents reported between 1990 and 1998 led to hundreds of deaths in Argentina, Bangladesh, India, and Nigeria.

The FDA notes that the Federal Food, Drug, and Cosmetic Act to regulate drug safety was enacted after more than 100 US deaths in 1937 were linked to the use of DEG-contaminated sulfanilamide elixir.

Because of the serious and potentially fatal nature of DEG-related adverse events, an FDA guidance document has been issued to the pharmaceutical industry regarding recommended methods of testing glycerin and other controls to identify potential contamination and prevent poisoning. The document is available online at http://www.fda.gov/cder/guidance/7654fnl.htm.

Healthcare professionals are encouraged to report adverse events potentially related to DEG-contaminated glycerin-containing products to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787. Yael Waknine is a freelance writer for Medscape.


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