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The Safety of Diclectin® in Breastfeeding

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The Safety of Diclectin® in Breastfeeding The Safety of Diclectin® in Breastfeeding By Cheuk Kiu Chow A thesis submitted in conformity with the requirements for the degree of Master of Science Department of Pharmacology and Toxicology University of Toronto © Copyright by Cheuk Kiu Chow, 2015 ii The Safety of Diclectin® in Breastfeeding Cheuk Kiu Chow Master of Science Department of Pharmacology and Toxicology University of Toronto 2015 Abstract Background and Rationale: Diclectin® is a delayed-release medication indicated for nausea and vomiting of pregnancy. Some mothers who are concurrently pregnant and breastfeeding also take Diclectin®. Hence, components of Diclectin® in breast milk may cause adverse events in the breastfed infants. This had not been studied before. Objective: To determine the safety and clinical significance of doxylamine exposure through breast milk in infants breastfed by mothers taking Diclectin®. Methods: 41 mothers concurrently taking Diclectin® and breastfeeding completed a telephone questionnaire regarding occurrence of adverse events in themselves and their breastfed infants. Data were analyzed and compared with results from other studies. Results: Maternal adverse events included sedation (29), dizziness (2), weakness (4), constipation (2), reduced lactation (2), abdominal pain (1), and increased appetite (1). Infant adverse events included sedation (5), constipation (1), slept less (1), and loose bowel (1). Conclusion: Mothers taking Diclectin® and their breastfed infants may experience sedation. iii Acknowledgments Firstly, I would like to thank my family for their support and encouragement throughout my study. Secondly, I would like to thank my mentor Ms. Caroline Maltepe. Her guidance and support throughout my study had proved essential and the lessons I learned from her will be indispensable for the rest of my life. Thirdly, I would like to thank Dr. Shinya Ito for supervising my project during a time of hardship. Without his help, I would not be able to finish this study. Fourthly, I would like to thank Dr. Bhushan Kapur and Dr. Irena Nulman, fellows at the Motherisk Program, and other graduate students at Motherisk for mentoring and allowing me to explore different facets of clinical pharmacology and toxicology. Lastly and most importantly, I would like to sincerely thank Dr. Gideon Koren for taking me under his guidance and supervision at the Motherisk Program, which has provided me a multitude of experiences in clinical research. I shall not forget the lessons from this experience. iv Potential Conflict of Interest This study was sponsored by Duchesnay Inc., the manufacturer of Diclectin®. Dr. Gideon Koren is a paid consultant for Duchesnay Inc. v Table of Contents Acknowledgments.......................................................................................................................... iii Potential Conflict of Interest .......................................................................................................... iv Table of Contents .............................................................................................................................v List of Tables ............................................................................................................................... viii List of Figures ................................................................................................................................ ix List of Abbreviations .......................................................................................................................x Chapter 1. Introduction ..............................................................................................................1 1.1 Statement of the Problem .....................................................................................................1 1.2 Overall Objective .................................................................................................................2 1.3 Methods in Brief ..................................................................................................................2 1.4 Research Question and Hypothesis ......................................................................................2 Chapter 2. Literature Review of the Study Drug .......................................................................3 2.1 Diclectin® .............................................................................................................................3 2.1.1 Teratogenicity of Doxylamine-Pyridoxine Combination Treatments for NVP .......3 2.1.2 Common Side Effects of Diclectin®/Bendectin®/Debendox® .................................4 2.1.3 Bendectin®/Debendox® Overdose/Toxicity in Young Children ..............................5 2.1.4 Pharmacokinetic Studies of Diclectin® ....................................................................6 2.1.5 Doxylamine ..............................................................................................................8 2.1.5.1 Physicochemical Properties of Doxylamine – How Likely Will It Enter Breast Milk? .....................................................................................9 2.1.5.2 Pharmacokinetics of Doxylamine ............................................................12 2.1.5.3 Metabolism of Doxylamine .....................................................................14 2.1.5.4 Common Side Effects of Doxylamine .....................................................18 2.1.5.4.1 Overdose ................................................................................................. 18 2.1.6 Vitamin B6/Pyridoxine ..........................................................................................20 vi 2.1.6.1 Pharmacokinetic and Physicochemical Properties of Vitamin B6/Pyridoxine ..........................................................................................22 2.1.6.2 Dietary Reference Intake .........................................................................26 2.1.6.3 Vitamin B6/Pyridoxine Toxicity .............................................................28 2.1.6.4 Vitamin B6 deficiency in breastfed infants .............................................29 2.1.6.5 Vitamin B6 status of mothers and breast milk ........................................29 2.1.6.5.1 Using Vitamin B6 to Suppress Puerperal Lactation? ............................. 31 Chapter 3. Other NVP Medications and Breastfeeding ...........................................................36 3.1 Diphenhydramine and Dimenhydrinate .............................................................................36 3.2 Metoclopramide .................................................................................................................37 3.3 Acid-Reducing Drugs ........................................................................................................38 Chapter 4. Methods of Assessing Infant Exposure to Drugs in Breast Milk...........................39 4.1 Milk/Plasma Ratio .............................................................................................................39 4.2 Relative Infant Dose ..........................................................................................................41 4.3 Oral Bioavailability ............................................................................................................41 4.4 Infant Plasma Concentrations ............................................................................................42 Chapter 5. Methods..................................................................................................................43 5.1 Setting ................................................................................................................................43 5.2 Study Design ......................................................................................................................43 5.3 Study Group Subject Recruitment .....................................................................................43 5.3.1 Prospective Recruitment ........................................................................................43 5.3.2 Retrospective Recruitment .....................................................................................44 5.3.3 Interview ................................................................................................................44 5.3.4 Inclusion and Exclusion Criteria ............................................................................44 5.3.5 Recruitment Outcome ............................................................................................45 5.4 Data Collection and Target Endpoints ...............................................................................45 vii 5.5 Analysis..............................................................................................................................47 5.5.1 Statistical Analysis .................................................................................................47 5.5.2 Post-Hoc Comparisons...........................................................................................48 Chapter 6. Results ....................................................................................................................50 6.1 Study Population ................................................................................................................50 6.2 Diclectin® and NVP-Related Data .....................................................................................53
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