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HERO ID
5509166
Reference Type
Journal Article
Title
Identification of phthalates in medications and dietary supplement formulations in the United States and Canada
Author(s)
Kelley, KE; Hernández-Díaz, S; Chaplin, EL; Hauser, R; Mitchell, AA
Year
2012
Is Peer Reviewed?
Yes
Journal
Environmental Health Perspectives
ISSN:
0091-6765
EISSN:
1552-9924
Volume
120
Issue
3
Page Numbers
379-384
Language
English
PMID
22169271
DOI
10.1289/ehp.1103998
Web of Science Id
WOS:000301394700025
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.
Tags
•
Dibutyl Phthalate (DBP)
Database Searches
Pubmed
Web of Science
LitSearch Nov 2012
PubMed
WOS
Merged reference set
LitSearch Dec 2012 - June 2013
Web of Science
Excluded: No Primary Data on Health Effects
Exposure levels
•
Diethyl phthalate (DEP)
Database searches
Initial Litsearch
Web of Science
Merged reference set
Aug 2013 update
Web of Science
Jan 2020 update
PubMed
Web of Science
Excluded: No Primary Data on Health Effects
Exposure levels
•
Phthalates – Targeted Search for Epidemiological Studies
Source – all searches
Pubmed
WOS
Toxnet
Excluded
Source – no date limit through June 2013 (Private)
Pubmed
WOS
ToxNet
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