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. 2012 Mar;120(3):379-84.
doi: 10.1289/ehp.1103998. Epub 2011 Dec 15.

Identification of phthalates in medications and dietary supplement formulations in the United States and Canada

Katherine E Kelley  1 , Sonia Hernández-Díaz, Erica L Chaplin, Russ Hauser, Allen A Mitchell
Affiliations

Identification of phthalates in medications and dietary supplement formulations in the United States and Canada

Katherine E Kelley et al. Environ Health Perspect. 2012 Mar.

Abstract

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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Conflict of interest statement

K.E.K and A.A.M. are employed by and E.L.C. was previously associated with the Slone Epidemiology Center, which receives funding for unrelated research from various pharmaceutical companies. S.H.D. and A.A.M. have received unrestricted research and training grants from pharmaceutical companies, some of which manufacture drugs discussed in this article. The remaining author declares he has no actual or potential competing financial interests.

Comment in

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