New Standards Set for Heparin and Glycerin
WEDNESDAY, Feb. 4 -- In a continuing effort to prevent counterfeit and adulterated medications from reaching American consumers, the U.S. Food and Drug Administration is adopting stricter standards for heparin and glycerin -- two widely used drug products at the center of recent contamination episodes.
The new standards were created by the U.S. Pharmacopeia (USP) Convention, a nonprofit health organization that sets public standards for prescription and over-the-counter medicines and other health-care products made or sold in the United States.
"These are ongoing changes for our standards for heparin, and for glycerin that might be contaminated with toxins called ethylene glycol and diethylene glycol," said USP Chief Science Officer Dr. Darrell R. Abernethy. "The reason is to protect the public health."
Starting in November 2007, there were hundreds of severe reactions among patients receiving heparin, a blood thinner, and most were patients on kidney dialysis. Some 200 people died from the reactions, Abernethy said.
"There was almost certainly a contaminate put in the heparin in China that caused these reactions," he said. "It was done in such a clever, devious way that it passed our standards."
The contaminated heparin from China was tainted with over-sulfated chondroitin sulfate, which is made from the dietary supplement chondroitin and mimics heparin's blood-thinning properties, Abernethy explained.
The USP had to fix the standard so that adulterated heparin would not be allowed to come into the United States, Abernethy said. In a first step, the USP did a "quick fix" last year, which dealt with the immediate problem from China.
Now, there will be a permanent change in the standard that takes effect in August. After that time, manufacturers and importers of heparin will have to use the new standard to test their products before they can be sold in the United States. The new standard includes a specific chemical identification of heparin that spots the chemicals in the heparin more precisely than was done before, Abernethy said.
Glycerin is a chemical used to sweeten products such as toothpaste and pancake syrup, while ethylene glycol and diethylene glycol are poisonous. Switching ethylene glycol, which is used in antifreeze, as a cheap substitute for glycerin goes back as far as 1937 when more than 107 people were killed in the United States by ethylene glycol used as a liquid base for an antibiotic, Abernethy said.
Recently, there have been cases of ethylene glycol or diethylene glycol contamination in toothpaste from China found in the United States and Panama. The latest case occurred in November, when 34 Nigerian children died after being given a tainted teething drug, according to the FDA.
With that background, the FDA asked the USP to improve the standard for glycerin, to exclude ethylene glycol or diethylene glycol from glycerin, Abernethy said.
Before this change, manufacturers were only required to spot test their products for these chemicals. Now manufacturers will have to test for these chemicals in all the glycerin that comes into their plants, Abernethy said. The new standard takes effect in May.
"The approach that the FDA is using to enforce these standards for heparin and glycerin means that these impurities should not happen again," Abernethy said.
Dr. David L. Katz, director of the Yale University School of Medicine's Prevention Research Center, said he wasn't convinced that these new standards will keep all tainted drugs or other products out of the country.
"In a world of global commerce, perfect defenses against tainted or adulterated drugs are achievable, but at costs few would be willing to pay," Katz said. "It would require high-volume inspection, strict quality-control standards, and a massively costly surveillance effort to let the good products through, while unfailingly filtering out the bad."
"Are higher quality standards and more scrutiny for heparin and glycerin a perfect defense against drug adulteration? Surely not," Katz said. "But they are a good step in the right direction."
For more on drug safety, visit the U.S. Food and Drug Administration.
Posted: February 2009