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ACC Responds to Study Published in Pediatrics About Phthalate and IV Tubing

ARLINGTON, Va., July 27 /PRNewswire-USNewswire/ -- The American Chemistry Council (ACC) today responded to the article in Pediatrics: H. von Rettberg, T. Hannman, U. Subotic, J. Brade, T. Schaible, K. L. Waag, S. Loff, Use of Di(2-Ethylhexyl)Phthalate-Containing Infusion Systems Increases the Risk for Cholestasis, Pediatrics 124(2): 710-716 (August 2009).

Total parenteral nutrition - delivery of nutrition intravenously via plastic tubing - is a life-saving treatment used with newborns who are too small or whose digestive system is too compromised to be fed normally. This study explores the relationship between a condition called cholestasis and the use of phthalate-bearing vinyl tubing, but the conclusions are questionable. As the author states, the infants in the study suffered medical conditions which by themselves lead to. . .an increase in parameters of cholestasis. Cholestasis is a relatively common complication among newborns that need intravenous feeding. Indeed, six of the newborns in this study developed the condition even though they were treated with phthalate-free tubing. Please refer to our Web site discussion of this subject.

ACC senior director of the Phthalate Esters Panel, Steve Risotto, issued the following statement:

This study does not show any direct cause and effect, but rather includes a multitude of confounding factors. Importantly, it does not answer whether the development of cholestasis in these seriously troubled infants was related to the presence of DEHP in the vinyl tubing, or to the more severe underlying conditions of the infants prior to initiation of TPN. Six of the newborns in this study developed cholestasis even though they were fed with phthalate-free tubing. In short, the authors' conclusions that 'the study shows that the DEHP load caused by polyvinylchloride infusion systems for TPN constitutes an important factor in the occurrence of cholestasis' are not supported by the data.

It is important to note that FDA cautions that "you should not avoid the procedures. . .because of the possibility of health risks associated with DEHP exposure. The risk of not doing a needed procedure is far greater than the risk associated with exposure to DEHP."

The American Chemistry Council (ACC) represents the leading companies engaged in the business of chemistry. ACC members apply the science of chemistry to make innovative products and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health and safety performance through Responsible Care(R), common sense advocacy designed to address major public policy issues, and health and environmental research and product testing. The business of chemistry is a $689 billion enterprise and a key element of the nation's economy. It is one of the nation's largest exporters, accounting for ten cents out of every dollar in U.S. exports. Chemistry companies are among the largest investors in research and development. Safety and security have always been primary concerns of ACC members, and they have intensified their efforts, working closely with government agencies to improve security and to defend against any threat to the nation's critical infrastructure.

SOURCE American Chemistry Council
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