Statement

Study Does Not Answer Whether Phthalates and a Common Newborn Disorder, Cholestasis, are Related

ARLINGTON, VA (July 27, 2009) –  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.’”

To read more about ACC’s response to the study in the media, click here.

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