Investigation and Analysis of the Information Available for Pregnant and Lactating Women in 308 Antipsychotic Package Inserts

Abstract

Background: Package insert is an important tool to provide safe and reasonable guidance for pregnant and lactating women. Methods: The information on pregnant women in 308 package inserts of 38 kinds of antipsychotics on the market was analyzed. Results: 287 (93.18%) package inserts in the 308 antipsychotics provide drug use guiding information for pregnant women, while 150 (48.70%) of them made it clear that the drug could be used normally, cautiously or forbidden on pregnant women. 137 (44.48%) of them used different expressions. There were 64 (20.78%) instructions that made it clear that the drug could be used normally, cautiously or forbidden on lactation women. 81 (26.30%) instructions are recommended to stop breastfeeding. 142 (46.10%) instructions for breastfeeding women used different expressions. Contradictions were found in 23.53% drugs for pregnant women and 29.41% for lactation women. Conclusion: There are some problems with drug information on pregnant women in package inserts，such as inadequate information and inaccurate description. To ensure safer use, the package inserts of medicines should be further improved.