Therapeutic Area: This book provides information on the safe use of prescription and nonprescription drugs during pregnancy and breast-feeding.
Format: Marking the 25th year since its first publication, the 8th edition of this hardcover reference book contains monographs on nearly 1200 drugs. A preface describing the structure of the book and how to use it is followed by an alphabetical listing of drug monographs, using generic names. An appendix is included. An online version is also available to those who purchase the book.
Audience: The primary audience appears to be pharmacists and physicians, but other healthcare providers, such as lactation consultants, may also find this reference quite useful.
Purpose: To provide the clinician with the “best estimate of embryo/fetal and nursing infant risk” for drugs used during pregnancy and lactation.
Content: Each monograph contains 6 sections and has a standardized format: US generic name, pharmacologic class, risk factor, fetal risk summary and recommendations, breast-feeding summary and recommendations, and references when available. For easy review, 5 of the 6 sections are enclosed in a box at the beginning of each monograph. The summaries provide brief reviews of existing literature on the subject, including manufacturer recommendations. The recommendations are intended to assist with determination of level of risk of a specific drug. The pregnancy (fetal risk) recommendations, grouped into compatible, probably compatible, contraindicated in a specific trimester, or contraindicated throughout pregnancy rankings, only apply to the usual therapeutic drug dose for a typical patient. The recommendations for breast-feeding are categorized into compatible, potential toxicity, and contraindicated rankings. These are based on the known toxicity of the drug or of similar drugs in adults or children (when known) and the amount of drug excreted in breast milk (if known). The summaries are followed by references.
Risk factors are assigned to all drugs based on the level of risk they pose to the fetus. Although these help the reader quickly classify a drug for use during pregnancy, clinicians are always advised to use this risk factor classification in conjunction with the fetal risk summary. These classifications do not refer to breast-feeding risk. Breast-feeding risk factors are defined using a system similar to that used by the Food and Drug Administration. The overall recommendation is divided into 3 broad categories: compatible, no human data (with an added comment on the potential for toxicity), or contraindicated.
Usability: The usability of this edition is much improved over the previous editions. The boxed drug names, as well as the fetal and breast-feeding recommendations, are easy to find and interpret.
Highlights: The standardized format of the monographs, the indexed generic and trade name cross-references (including foreign trade names), and availability of the online version, providing the convenience of having the reference available at any time, make this reference desirable and user friendly.
Limitations: Although this publication is multidisciplinary in nature and can be used on all pediatric wards that deal with such issues, the publisher does not offer an institutional subscription, thus limiting its timely accessibility to multiple users.
Comparison with Previous Edition or Version: There are several changes to the 8th edition. First, 125 new monographs have been added, making the reference more comprehensive. This edition includes data on more herbal medicines and nutritional supplements used by women and contains lists of drugs contraindicated during breast-feeding and pregnancy, as well as drugs known to cause human developmental toxicity. Second, the overall recommendations now include recommendations about both fetal risk and breast-feeding in a highlighted box at the beginning of the monograph, along with the fetal risk factor category. This provides the reader with a quick classification but should not be used as a substitute for the entire monograph, which should be read before making a final clinical decision. Finally, the complete text of this new edition is now available online, making it more accessible to the practicing clinician.
Comparison with Other Related Books or Products: This is a unique, comprehensive reference that incorporates data from research as well as from drug manufacturers’ literature when developing the drug monographs.
Reviewer's Summary: The text provides extremely useful information on drug use during pregnancy and lactation. It is well organized and easy to use. However, the size of the text limits its portability. Likewise, lack of an online version that is easily available to institutions makes it less useful for healthcare providers.
Reviewer: Varsha Bhatt-Mehta MS (CRDSA) PharmD FCCP; Clinical Associate Professor; Pharmacy, Pediatrics and Communicable Diseases; Departments of Pediatrics and Clinical, Social, and Administrative Sciences; University of Michigan, Ann Arbor, MI
