Pharmaceuticals and Pregnancy: From Testing to Labeling

• Published in: Drug information journal Vol. 33; no. 4; pp. 1125 - 1133
• Main Authors: van der Laan, Jan Willem, Olejniczak, Klaus
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.10.1999; Pergamon Press; Springer Nature B.V
• Subjects: Biological and medical sciences; Clinical trials; Drug toxicity and drugs side effects treatment; Labeling; Medical sciences; Miscellaneous (drug allergy, mutagens, teratogens...); Pharmacology. Drug treatments; Pregnancy; Regulatory agencies; Toxicity; Pregnancy; Reproduction toxicity; Animal studies; Labeling; Classification; Pharmaceuticals; Human; Drug; Toxicity; European Union; Animal; Risk factor; Man animal extrapolation; Clinical trial; Female; Information
• ISSN: 2168-4790; 0092-8615; 2164-9200; 2168-4804
• DOI: 10.1177/009286159903300417

Classification and labeling of medicines for use during pregnancy is a subject of constant debate, particularly within regulatory agencies. This report summarizes the outcome of a discussion of a DIA workshop held in 1998 in Munich, Germany. The following issues were on the table: 1. To what extent and how should the information derived from animal studies be presented in the Summary of Product Characteristics? 2. What are the requests for toxicity studies to include women of childbearing potential in clinical trials? 3. What is sufficient human experience and how can it be achieved? and 4. New proposals of the text for the label from the Committee for Proprietary Medicinal Products (CPMP), the regulatory authority in Europe.