The label on most medicines are missing information on safety in pregnancy and breastfeeding. To address this gap, pharmaceutical companies are requested to develop post-approval studies to assess safety. But even when companies carry out these post approval observational studies to generate evidence of safety data, a landscape study from the ConcePTION project published in Drug Safety, shows that the results rarely make it to the product label.
Researchers looked at post-marketing studies that were registered either in the EU PAS register, or ClinicalTrials.gov, focusing on pregnancy outcomes and breastfeeding effects. The study extracted information on the variables of interest from the eligible observational studies and compared those with primary data collection and studies with secondary use of heath data. This was followed by an assessment of whether the study results had any impact on the respective product label.
The authors found that observational studies of drug safety involving pregnant and breastfeeding women that were based on secondary use of health data include more study subjects. Studies based on secondary use of health data also completed faster than studies based on primary data collection. However, despite the fact that 46 studies are being completed with final reports or published papers, the number of product labels that were updated based on the respective observational studies was very low: in fact, onlytwo labels were updated as a result. According to the authors, the breastfeeding sections of product labels have not been updated as the completed studies focused only on prenatal exposure.
“Our study suggests that the current product label process should facilitate inclusion of new data on safety of medicines during pregnancy and breastfeeding. We recommend making better use of existing health data across multiple database”, says Leonardo Roque Pereira from the Department of Data Science & Biostatistics, Julius Center for Health Sciences and Primary Care at the University Medical Center Utrecht.
Read the article in full: Roque Pereira L, Durán CE, Layton D, Poulentzas G, Lalagkas P-N, Kontogiorgis C & Sturkenboom M, A Landscape Analysis of Post-Marketing Studies Registered in the EU PAS Register and ClinicalTrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from the ConcePTION Project, Drug Safety, 45 333-344, 2022, https://doi.org/10.1007/s40264-022-01154-7
By Josepine Fernow