Leaching of Diethylhexyl Phthalate from Polyvinyl Chloride Containers by Selected Drugs and Formulation Components

Pearson, Stephen D.; Trissel, Lawrence A.

doi:10.1093/ajhp/50.7.1405

Cited by 61 publications

(49 citation statements)

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“…DEHP has been measured in blood products (whole blood, plasma, platelet, and packed red cells) at 4±650 mg/L [Jaeger and Rubin, 1970;Gibson et al, 1976;Schneider et al, 1989;Chawl and Hinberg, 1991;Huber et al, 1996] drug-containing solutions (3.1±237 mg/L); and in sterile water, electrolyte, and sugar-based solutions (5 mg/L) [Pearson and Trissel, 1993;Baxter Healthcare, 1995;Mazzo et al, 1997;Trissel, 1998].…”

Section: Medical Exposuresmentioning

confidence: 99%

Health risks posed by use of Di-2-ethylhexyl phthalate (DEHP) in PVC medical devices: A critical review

et al. 2001

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Background Polyvinyl chloride plastics (PVC), made flexible through the addition of di‐2‐ethylhexyl phthalate (DEHP), are used in the production of a wide array of medical devices. From the late 1960s, leaching of DEHP from PVC medical devices and ultimate tissue deposition have been documented. Methods A critical review of DEHP exposure, metabolism, and toxicity data from human and animals studies was undertaken. A brief analysis of alternatives to DEHP‐plasticized PVC for use in medical device manufacture was completed. Results DEHP leaches in varying concentrations into solutions stored in PVC medical devices. Certain populations, including dialysis patients and hemophiliacs may have long‐term exposures to clinically important doses of DEHP, while others, such as neonates and the developing fetus, may have exposures at critical points in development. In vivo and in vitro research links DEHP or its metabolites to a range of adverse effects in the liver, reproductive tract, kidneys, lungs, and heart. Developing animals are particularly susceptible to effects on the reproductive system. Some adverse effects in animal studies occur at levels of exposure experienced by patients in certain clinical settings. DEHP appears to pose a relatively low risk of hepatic cancer in humans. However, given lingering uncertainties about the relevance of the mechanism of action of carcinogenic effects in rodents for humans and interindividual variability, the possibility of DEHP‐related carcinogenic responses in humans cannot be ruled out. Conclusions The observed toxicity of DEHP and availability of alternatives to many DEHP‐containing PVC medical devices presents a compelling argument for moving assertively, but carefully, to the substitution of other materials for PVC in medical devices. The substitution of other materials for PVC would have an added worker and community health benefit of reducing population exposures to DEHP, reducing the creation of dioxin from PVC production and disposal, and reducing risks from vinyl chloride monomer exposure. Am. J. Ind. Med. 39:100–111, 2001. © 2001 Wiley‐Liss, Inc.

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Section: Medical Exposuresmentioning

confidence: 99%

Health risks posed by use of Di-2-ethylhexyl phthalate (DEHP) in PVC medical devices: A critical review

et al. 2001

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“…There are numerous reports on the leachables, such as metals, DEHP, cyclohexanone, and other organic and acidic compounds, found in the solution of PVC bags [15,[18][19][20][21][22]. The leachables have the potential to interact with and alter the drug to be administered [23,24].…”

Section: Introductionmentioning

confidence: 99%

Leachables from Saline-Containing IV Bags Can Alter Therapeutic Protein Properties

Chang

Xiao

Zhu³

et al. 2010

Pharm Res

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“…Di-ethylhexyl phthalate (DEHP) is the plasticiser most widely used in the manufacture of medical materials. As it is not covalently bound to the plastic matrix, it can be released from the PVC when this is placed in contact with lipophilic solutions [1].…”

Section: Introductionmentioning

confidence: 99%

Analysis by liquid chromatography and infrared spectrometry of di(2-ethylhexyl)phthalate released by multilayer infusion tubing

Bourdeaux¹,

Sautou

Bagel-Boithias³

et al. 2004

Journal of Pharmaceutical and Biomedical Analysis

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Leaching of Diethylhexyl Phthalate from Polyvinyl Chloride Containers by Selected Drugs and Formulation Components

Cited by 61 publications

References 0 publications

Health risks posed by use of Di-2-ethylhexyl phthalate (DEHP) in PVC medical devices: A critical review

Health risks posed by use of Di-2-ethylhexyl phthalate (DEHP) in PVC medical devices: A critical review

Leachables from Saline-Containing IV Bags Can Alter Therapeutic Protein Properties

Analysis by liquid chromatography and infrared spectrometry of di(2-ethylhexyl)phthalate released by multilayer infusion tubing

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