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World J Gastroenterol. Nov 7, 2013; 19(41): 7042-7047
Published online Nov 7, 2013. doi: 10.3748/wjg.v19.i41.7042
Presence of phthalates in gastrointestinal medications: Is there a hidden danger?
Zane R Gallinger, Geoffrey C Nguyen
Zane R Gallinger, Geoffrey C Nguyen, Mount Sinai Hospital Centre for Inflammatory Bowel Disease, University of Toronto, Toronto, Ontario, M5G 1X5, Canada
Geoffrey C Nguyen, Division of Gastroenterology, Johns Hopkins University School of Medicine, Baltimore, MD 21287, United States
Author contributions: Gallinger ZR and Nguyen GC contributed equally to this work.
Correspondence to: Geoffrey C Nguyen, MD, PhD, FRCPC, Mount Sinai Hospital Centre for Inflammatory Bowel Disease, University of Toronto, 600 University Avenue, Ste. 437, Toronto, Ontario, M5G 1X5, Canada. geoff.nguyen@utoronto.ca
Telephone: +1-416-5864800 Fax: +1-416-5865971
Received: July 24, 2013
Revised: August 26, 2013
Accepted: September 15, 2013
Published online: November 7, 2013
Abstract

Pharmaceutical companies that produce gastrointestinal (GI) medications often utilize phthalates for their ability to localize medication release. Commonly prescribed GI medications that may utilize phthalates are 5-Aminosalicylates, proton pump inhibitors, and pancreatic enzymes. Our understanding of the cumulative health effects of phthalates from medications remains unclear, and there is increasing evidence that phthalates are not harmless. Experimental studies in animals have shown that phthalates, specifically dibutyl phthalate and Di-(2-ethyl-hexyl) phthalate, have the potential to alter and/or inhibit reproductive biology and in utero development. Despite the lack of definitive human data, many cohort and cross-sectional studies demonstrate concerning associations between phthalates and poor health status, specifically developmental problems. Longitudinal studies and studies with larger sample sizes are required to determine whether phthalates actually cause negative health consequences. It is also important that physicians regularly review and discuss with patients the medicinal ingredients in their medications and supplements, specifically in pregnant woman with inflammatory bowel disease.

Keywords: Phthalates, Dibutyl phthalate, 5-Aminosalicylates, Medications, Development, Pregnancy

Core tip: Phthalates are widely used as excipients in medications used to treat gastrointestinal disease. Research into the adverse effects associated with certain phthalates continues to produce uncertainty regarding the safety of their use in medications. Gastroenterologists should be aware of the potential harm of specific phthalates so that they can make informed decisions of whether the benefits of the medication outweigh the potential risks. Additional studies using human populations will help elucidate if regulatory bodies should mandate the use of alternative excipients.