Identification of phthalates in medications and dietary supplement formulations in the United States and Canada.
Identification of phthalates in medications and dietary supplement formulations in the United States and Canada.
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DOI：
10.1289/ehp.1103998
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发表时间：
2012-03
影响因子：
10.4
通讯作者：
Mitchell AA
中科院分区：
文献类型：
--
作者：
Kelley KE;Hernández-Díaz S;Chaplin EL;Hauser R;Mitchell AA
Background: In animal studies, some ortho-phthalates, including di(2-ethylhexyl) phthalate (DEHP) and di-n-butyl phthalate (DBP), have been shown to be reproductive and developmental toxicants. Human studies show widespread population exposure to background levels of phthalates. Limited evidence suggests that particularly high exposure levels may result from orally ingested medicinal products containing phthalates as excipients (inactive ingredients). Objective: In this study we aimed to identify and describe the scope of prescription (RX) and nonprescription (over-the-counter; OTC) medicinal products and dietary supplements marketed in the United States and Canada since 1995 that include phthalates as excipients. Methods: We used lists of modified-release drug products to identify potential drug products. Inclusion of phthalates was verified using available electronic databases, print references, published package inserts, product packages, and direct communication from manufacturers. Additional products were identified using Internet searches utilizing keywords for phthalates. Results: Based on labeling information, 6 RX drug products included DBP as an excipient, and 45 specified the use of diethyl phthalate (DEP). Phthalate polymers with no known toxicity—hypromellose phthalate (HMP), cellulose acetate phthalate (CAP), and polyvinyl acetate phthalate (PVAP)—were included in 75 RX products. Three OTC drug and dietary supplement products listed DBP, 64 listed DEP, and > 90 indicated inclusion of polymers. Conclusions: Numerous RX and OTC drug products and supplements from a wide range of therapeutic categories may use DBP or DEP as excipients in oral dosage forms. The potential effects of human exposure to these phthalates through medications are unknown and warrant further investigation.
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影响因子：
10.4
作者：
Hauser R;Duty S;Godfrey-Bailey L;Calafat AM
通讯作者：
Calafat AM
影响因子：
4.3
作者：
Keller, Bernd O.;Davidson, A. George F.;Innis, Sheila M.
通讯作者：
Innis, Sheila M.
影响因子：
10.4
作者：
Silva MJ;Barr DB;Reidy JA;Malek NA;Hodge CC;Caudill SP;Brock JW;Needham LL;Calafat AM
通讯作者：
Calafat AM
影响因子：
2.2
作者：
Osterberg, RE;See, NA
通讯作者：
See, NA
药物是美国人群中邻苯二甲酸盐的潜在来源。
影响因子：
10.4
作者：
Hernández-Díaz S;Mitchell AA;Kelley KE;Calafat AM;Hauser R
通讯作者：
Hauser R