Investigation and Analysis of the Information Available for Pregnant Women in 1102 Antibiotic Package Inserts

Abstract

Objective To understand the current status of information on use by pregnant women in antibiotic package inserts. Methods Information related to use by pregnant women, was obtained from the package inserts of 66 commercially available antibiotics and was investigated and analyzed. The drugs were classified as follows according to their pharmacological effects: penicillins; first-, second-, third-, and fourth-generation cephalosporins; cephamycins; aminoglycosides; macrolides; tetracyclines; lincosamides; glycopeptide antibiotics; carbapenems; third-and fourth-generation quinolones; sulfonamides; and nitroimidazoles. Results A total of 1102 package inserts of 66 common commercially available antibiotics were obtained. Among them, 72.14% (795) package inserts included labels with advice for pregnant women, backed by relevant research data, whereas 23.23% (256) included labeling on the use by pregnant women without such experimental or relevant research data. In addition, 2.00% (22) of these inserts included unclear information, whereas the information was missing in 2.63% (29). Finally, 10.60% (7) of the package inserts contained contradictory information across manufacturers. Package inserts of some antibiotics are either not standardized or lack relevant information for use of these drugs by pregnant women, making it difficult to meet the needs of users and ensure medication safety. Conclusion Standardized management of drug package inserts must thus be enhanced.