DEHP Unlikely To Pose Health Risk Even With High Exposure - ACSH Panel
This article was originally published in The Gray Sheet
Executive Summary
The primary plasticizer used to impart flexibility to many polyvinyl chloride (PVC) medical devices such as I.V. bags, di(2-ethylhexyl) phthalate (DEHP), is "unlikely to pose a health risk to even highly exposed humans," according to an expert panel chaired by former Surgeon General C. Everett Koop, MD.
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PVC
Risk assessment of di (2-ethylhexyl) phthalate (DEHP) performed by the Office of Science and Technology in 2000 will help form the basis for the device center's decision on a June 1999 Heath Care Without Harm citizen petition (1"The Gray Sheet" June 28, 1999, p. 12). The petition called for labeling polyvinyl chloride devices with warnings that indicate potential hazards of DEHP leaching from the PVC device and information on FDA-approved alternatives to PVC. The OST risk hazard report is currently being reviewed by the FDA Senior Science Council and could be released to the public as soon as mid-August, staffers indicate
PVC
Risk assessment of di (2-ethylhexyl) phthalate (DEHP) performed by the Office of Science and Technology in 2000 will help form the basis for the device center's decision on a June 1999 Heath Care Without Harm citizen petition (1"The Gray Sheet" June 28, 1999, p. 12). The petition called for labeling polyvinyl chloride devices with warnings that indicate potential hazards of DEHP leaching from the PVC device and information on FDA-approved alternatives to PVC. The OST risk hazard report is currently being reviewed by the FDA Senior Science Council and could be released to the public as soon as mid-August, staffers indicate
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Researchers should place greater emphasis on toxicology and reproduction studies to determine the effects of di (2-ethylhexyl) phthalate (DEHP) in humans, a clinical discussion group convened by FDA's Center for Biologics Evaluation and Research and Center for Devices and Radiological Health concluded Oct. 18.