The pre- and post-authorisation data published by the European medicines agency on the use of biologics during pregnancy and lactation.

ABSTRACT:

Aims

The effects of biologics on reproduction/lactation are mostly unknown although many patients that receive biologics are women of reproductive age. The first objective of this study was to investigate the publicly available data on pregnancy/lactation before and after marketing authorization in Europe of biologics for the indications of rheumatologic inflammatory autoimmune diseases and inflammatory bowel disease. Secondary objectives included the assessment of the clinical relevance of the provided data and comparison of initial and post-authorization data.

Methods

Initial and post-authorization data were extracted from the European Public Assessment Reports and the latest versions of Summary of Product Characteristics using publicly available documents on the European

SUBMITTER: Ghalandari N 

PROVIDER: S-EPMC7080638 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature