Abstract
Background: Drugs that carry a concern for teratogenicity are often classified as pregnancy category X in the drug label and contraindicated for use during pregnancy. Many drug labels can be found in the Physicians’ Desk Reference (PDR), a widely used source of drug information by American clinicians and patients.
Objective: To review product labelling in the electronic PDR for the pregnancy category X products for pregnancy prevention risk management components in labelling.
Methods: The electronic version of the 2001 and 2002 PDR was searched for ‘pregnancy category X’ products using the full text search feature. All product labels identified were retrieved and reviewed for trade name, generic name, manufacturer and indication. Product labels were manually searched for any pregnancy prevention risk management strategies included in labelling. Those labels that had specific pregnancy prevention risk management strategies were further evaluated.
Results: One hundred and seventeen pregnancy category X products were obtained from 2249 products searched in the 2001 PDR database and 124 pregnancy category X products were obtained from the 2150 products in the 2002 PDR database. All pregnancy category X products identified were drug products. The label/package insert for each drug was reviewed to identify risk management strategies for pregnancy prevention. The majority of the labels include as the sole risk management strategy either a black box warning and/or a contraindication for use in women who are or may become pregnant. Only 13 drugs contained specific pregnancy prevention risk management strategies in the label directing the clinician and/or patient, e.g. frequency of pregnancy testing, number and type of contraception methods. Two drugs, bexarotene capsules and gel, were only included in the 2001 PDR. Three drugs, isotretinoin, acitretin, and thalidomide, have formal pregnancy prevention risk management programmes.
Conclusion: This study demonstrates the varied risk management approaches in labelling for pregnancy prevention for pregnancy category X drugs. There is a need for consistency in the classification of pregnancy category X products and the pregnancy prevention risk management strategies utilised in the labelling for them.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Pregnancy labeling. FDA Drug Bull 1979; 9 (4): 23–4
Weiss S, Vega A, McCloskey C, et al. Drug use in pregnancy: prescription drug use during pregnancy among women in Kaiser Permanente Northwest, 1993-1994. Report to the Office of Women’s Health, US FDA, 1997 Oct 7
Lacroix I, Damase-Michel C, Lapeyre-Mestre M, et al. Prescription of drugs during pregnancy in France. Lancet 2000 Nov; 356(9243): 1735–6
Olesen C, Sorensen HT, Jong-Van Den Berg LD, et al. Prescribing during pregnancy and lactation with reference to the Swedish classification system: a populations-based study among Danish women. Acta Obstet Gynecol Scand 1999 Sep; 78(8): 686–92
Cohen JS, Insel PA. The Physicians’ Desk Reference: problems and possible improvements. Arch Intern Med 1996 Jul; 156(13): 1375–80
Hatton RC, Doering PL, Frias JL. Physicians’ sources of information about teratogenic effects of drugs. Drug Inf J 1982 Jul–Sep; 16(3): 148–53
Physicians’ Desk Reference. Suppl. B. 55th ed.Montvale (NJ): Medical Economics Company Inc, 2001
Friedman JM, Polifka JE. Teratogenic effects of drugs: a resource for clinicians (TERIS). 2nd ed. Baltimore (MD): The Johns Hopkins University Press, 2000
Scialli AR. A clinical guide to reproductive and development toxicology. Boca Raton (FL): CRC Press Inc, 1992
Sanz E, Gomes-Lopez T, Martinez-Quintas MJ. Perception of teratogenic risk of common medicines. Eur J Obstet Gynecol Reprod Biol 2001 Mar; 95(1): 127–31
Koren G, Bologa M, Long D, et al. Perception of teratogenic risk by pregnant women exposed to drugs and chemical during the first trimester. Am J Obstet Gynecol 1989 Aug; 160(5 Pt 1): 1190–204
Department of Health and Human Services, Food and Drug Administration. Requirements on content and format of labeling for human prescription drugs and biologics: requirements for prescription drug product labels. Fed Regist 2000 Dec; 65 (247): 81082–131
Department of Health and Human Services, Food and Drug Administration (FDA). Content and format of labeling for human prescription drugs, pregnancy labeling, public hearing–FDA: notice of public hearing, request for comments. Fed Regist 1997; 62: 41061–3
Boothby LA, Doering PL. FDA labeling system for drugs in pregnancy. Ann Pharmacother 2001 Nov; 35(11): 1485–9
Acknowledgements
The authors have received no sources of funding that were used to assist in conducting this study. The authors have no potential conflicts of interest that may be directly relevant to the contents of this manuscript. The opinions contained in this study are those of the authors only and should not be construed as representing the policies or positions of the Center for Drug Evaluation and Research and the Food and Drug Administration.
Author information
Authors and Affiliations
Corresponding author
Additional information
The use of tradenames is for product identification purposes only and does not imply endorsement.
Rights and permissions
About this article
Cite this article
Uhl, K., Kennedy, D.L. & Kweder, S.L. Risk Management Strategies in the Physicians’ Desk Reference Product Labels for Pregnancy Category X Drugs. Drug-Safety 25, 885–892 (2002). https://doi.org/10.2165/00002018-200225120-00006
Published:
Issue Date:
DOI: https://doi.org/10.2165/00002018-200225120-00006