Glycerin and Possible Contamination with Diethylene Glycol (DEG)

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FOR IMMEDIATE RELEASE

P07-81

May 4, 2007

Media Inquiries:

Kimberly Rawlings, 301-827-6242

Consumer Inquiries:

888-INFO-FDA

 

 

FDA Advises Manufacturers to Test Glycerin for Possible Contamination

Glycerin Contaminated with Diethylene Glycol (DEG) Remains a

Potential Health Hazard to Consumers

 

The U.S. Food and Drug Administration (FDA) is warning pharmaceutical

manufacturers, suppliers, drug repackers, and health professionals

who compound medications to be especially vigilant in assuring that

glycerin, a sweetener commonly used worldwide in liquid over-the-

counter and prescription drug products, is not contaminated with

diethylene glycol (DEG). DEG is a known poison used in antifreeze and

as a solvent. Today, the agency is issuing guidance to industry

recommending methods of testing glycerin and other controls to

identify any contamination with DEG before use in the manufacture or

preparation of pharmaceutical products.

 

At the present time, 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.

 

DEG poisoning is an important public safety issue and FDA is

exploring how supplies of glycerin become contaminated. In addition,

FDA is working with a variety of manufacturing and pharmacist

organizations to raise awareness of this risk and to put into place

controls to ensure that this problem does not happen in the U.S. or

elsewhere.

 

The most recent incident occurred in Panama in September 2006 and

involved DEG-contaminated glycerin used in cough syrup, which

resulted in dozens of hospitalizations for serious injury and more

than 40 deaths. In late 1995 and early 1996, at least 80 children

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. In 1937, more than 100 people died in

the United States after ingesting DEG-contaminated Elixir

Sulfanilamide, a drug used to treat infections. This incident led to

the enactment of the Federal Food, Drug, and Cosmetic Act, which is

the nation's primary statute on the regulation of drugs.

 

FDA reminds 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

manufacturers, compounders, repackers, and suppliers avoid the use of

glycerin that is contaminated with DEG and prevent incidents of DEG

poisoning.