FDA says beware of glycerin imported from China

May 7 2007

The Food and Drug Administration (FDA) in the United States has issued a warning to drug manufacturers, suppliers and health professionals that counterfeit drug additives have been using diethyline glycol, or DEG as a substitute for glycerin in cough medicine, fever medication and injectable drugs.

DEG is an industrial solvent commonly used in antifreeze and in recent years has caused deaths in Panama and Haiti when it was used as a substitute for glycerin, a more expensive sweet syrup, in cough medicine.

The FDA says some Chinese suppliers are using the poisonous DEG instead of glycerin and is warning manufacturers and suppliers of the importance of testing glycerin for DEG.

The FDA says although they have had no reported contamination cases as yet in the U.S. regarding DEG the most recent incident in Panama in September 2006 involved DEG-contaminated glycerin used in cough syrup and resulted in dozens of hospitalizations for serious injury and more than 40 deaths.

DEG is a chemical cousin of antifreeze that can cause kidney and neurological damage if ingested and though the source was eventually traced back by investigators in four countries to the Taixing Glycerine Factory factory in China, no one in China has ever been charged with causing the Panamanian deaths.

Previously in late 1995 and early 1996, at least 80 children also died in Haiti due to DEG-contaminated glycerin in acetaminophen syrup.

Between 1990 and 1998, similar incidents of DEG poisoning reportedly occurred in Argentina, Bangladesh, India, and Nigeria and resulted in hundreds of deaths.

It was an incident in 1937 when more than 100 people died in the United States after ingesting DEG-contaminated Elixir Sulfanilamide, a drug used to treat infections which led to the enactment of the Federal Food, Drug, and Cosmetic Act, which is the nation's primary statute on the regulation of drugs.

The FDA is reminding pharmaceutical manufacturers, compounders, repackers, and suppliers, as well as brokers and distributors, that all pharmaceutical manufacturing operations, including the re-packaging and re-labeling of ingredients like glycerin, must conform to current good manufacturing practice (CGMP).

The guidance provides recommendations for complying with CGMP and is intended to help them avoid the use of glycerin that is contaminated with DEG and prevent incidents of DEG poisoning.

Apparently manufacturing and pharmacist organizations are working with the FDA to ensure controls are in place which guard against such a problem ever happening again in the U.S. or elsewhere.

Officials in the U.S. are currently investigating the contamination of pet foods with the chemical melamine again from China, which is normally used to make plastic kitchen utensils and fertilizers.

The poison has killed or sickened an unknown number of dogs and cats and led to the recall of more than 100 brands of pet food.

The incidents have raised concerns about the safety of imports from China to the U.S. and highlights the frequent lack of transparency on the part of Chinese officials.