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News From the Food and Drug Administration
November 7, 2001

Safety Assessment of DEHP

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JAMA. 2001;286(17):2085. doi:10.1001/jama.286.17.2085-JFD10010-2-1

The FDA has assessed the safety of patients undergoing certain medical procedures (such as blood transfusion, intravenous infusion of crystalloid fluids and drugs, hemodialysis, peritoneal dialysis, total parenteral nutrition, enteral nutrition, and cardiopulmonary bypass) involving exposure to di-(2-ethylhexyl) phthalate (DEHP), a compound used as a plasticizer for polyvinyl choloride medical devices.

The agency concluded that there is little risk of DEHP-mediated effects in adults receiving intravenous solutions or undergoing peritoneal dialysis. However, the results of studies in young animals have suggested that prolonged exposure of male neonates to devices that release DEHP may affect the development of their testes and normal spermatogenesis. The full assessment is available at http://www.fda.gov/cdrh/ost/dehp-pvc.pdf.