Active Surveillance of the Safety of Medications Used in Pregnancy.

Active Surveillance of the Safety of Medications Used in Pregnancy.
Am J Epidemiol. 2021 Jan 11;:
Authors: Huybrechts KF, Kulldorff M, Hernández-Díaz S, Bateman BT, Zhu Y, Mogun H, Wang SV
Abstract
We rely on post-marketing approaches to define the risk of medications in pregnancy because information at the time of drug approval is limited. Most studies in pregnancy focus on a single or selected outcomes. However, women must balance the benefit of treatment against all possible adverse effects. Our objective was to apply and evaluate a tree-based scan statistic data mining method (TreeScan) as a safety surveillance approach that allows for simultaneous evaluation of a comprehensive range of adverse pregnancy outcomes, while preserving the overall false positive rate. We evaluated TreeScan with a cohort design and adjustment via propensity score techniques using two test cases: (1) opioids and neonatal opioid withdrawal syndrome, and (2) valproate and congenital malformations, implemented in pregnancy cohorts nested in the Medicaid Analytic eXtract (1/1/2000 - 12/31/2014) and IBM MarketScan Research Database (1/1/2003 - 9/30/2015). In both cases, we identified known safety concerns, with only one previously unreported alert at the preset statistical alerting threshold. This evaluation shows the promise of TreeScan-based approaches for systematic drug safety monitoring in pregnancy. A targeted screening approach followed by deeper in...

Source: Am J Epidemiol - January 11, 2021 Category: Epidemiology Authors: Huybrechts KF, Kulldorff M, Hernández-Díaz S, Bateman BT, Zhu Y, Mogun H, Wang SV Tags: Am J Epidemiol Source Type: research