Use of isotretinoin among girls and women of childbearing age and occurrence of isotretinoin-exposed pregnancies in Germany: A population-based study.

Background: Exposure to isotretinoin during pregnancy must be avoided due to its teratogenicity, but real-world data on its use are scarce. We aimed to describe (i) isotretinoin use in women of childbearing age in Germany; (ii) the occurrence of isotretinoin-exposed pregnancies; and (iii) malformations among children exposed in utero.

Methods And Findings: Using observational data from the German Pharmacoepidemiological Research Database (GePaRD, claims data from approximately 20% of the German population), we conducted annual cross-sectional analyses to determine age-standardized prevalence of isotretinoin use between 2004 and 2019 among girls and women aged 13 to 49 years.

Use of Acitretin Among Girls and Women of Childbearing Age and Occurrence of Acitretin-Exposed Pregnancies in Germany.

Background And Objective: Acitretin has long-lasting teratogenic properties. Therefore, pregnancies must be avoided during and within 3 years after acitretin treatment. We aimed to describe (i) acitretin use in women of childbearing age in Germany, (ii) the occurrence of acitretin-exposed pregnancies, and (iii) malformations among children exposed in utero.

Prescribing of endothelin receptor antagonists and riociguat in women of childbearing age in a large German claims database study.

Use of endothelin receptor antagonists (ERAs) and riociguat, approved for treatment of pulmonary hypertension (PH), is contraindicated during pregnancy due to reported teratogenicity in animals. We aimed to investigate prescribing of these drugs in girls/women of childbearing age and to explore - as a secondary aim - the occurrence of pregnancies exposed to these drugs. Using the German Pharmacoepidemiological Research Database (GePaRD, claims data from 20% of the German population) we conducted cross-sectional analyses to determine prescribing prevalence of ERAs and riociguat between 2004 and 2019 and to characterize users and prescribing patterns.

Use of Methotrexate in Girls and Women of Childbearing Age, Occurrence of Methotrexate-Exposed Pregnancies and Their Outcomes in Germany: A Claims Data Analysis.

Background And Objective: Methotrexate should be withdrawn before pregnancy because of its teratogenic potential. We aimed to describe the use of methotrexate in women of childbearing age in Germany and the occurrence and outcomes of pregnancies exposed to methotrexate.

Methods: Using the German Pharmacoepidemiological Research Database (GePaRD, covering ~ 20% of the German population), we determined the age-specific and age-standardized prevalence of methotrexate use for each year between 2004 and 2019 among women aged 13-49 years (cross-sectional analyses).

Fingolimod, teriflunomide and cladribine for the treatment of multiple sclerosis in women of childbearing age: description of drug utilization and exposed pregnancies in Germany.

Background: Authorizations of fingolimod, teriflunomide and cladribine were accompanied by risk minimization measures concerning their teratogenic potential. Real-world data on their use are scarce. We aimed to assess trends in the use of fingolimod, teriflunomide and cladribine among women of childbearing age, estimate the number of pregnancies occurring under treatment and explore the occurrence of malformations in newborns exposed during early pregnancy in Germany.

Characterization of pregnancies among women with epilepsy using valproate before or during pregnancy - A longitudinal claims data analysis from Germany.

Purpose: To characterize pregnancies among women with epilepsy who have filled a prescription for valproate at any time before or during pregnancy and to assess other antiepileptic drug (AED) prescriptions.

Methods: Based on health claims data (German Pharmacoepidemiological Research Database - GePaRD; covering ~20% of the population), we selected pregnancies beginning between 2014 and 2016 in women with at least three years of observation period before pregnancy and with at least one epilepsy diagnosis code in the year before pregnancy. Among those, we selected pregnancies with at least one valproate dispensation any time before or during pregnancy.

Characterization of pregnancies exposed to St. John's wort and their outcomes: A claims data analysis.

Little is known about the utilization of St. John's wort (Hypericum perforatum L.) during pregnancy.

Corrigendum: Estimating the Beginning of Pregnancy in German Claims Data: Development of an Algorithm With a Focus on the Expected Delivery Date.

[This corrects the article DOI: 10.3389/fpubh.2020.

Estimating the Beginning of Pregnancy in German Claims Data: Development of an Algorithm With a Focus on the Expected Delivery Date.

Estimating the beginning of pregnancy is crucial when studying drug safety in pregnancy, but important information in this regard, such as the last menstrual period (LMP), is generally not recorded in claims databases. The beginning of pregnancy is therefore usually estimated by subtracting a median length of pregnancy from the date of birth. Due to the variability in pregnancy lengths, this might result in non-negligible errors.

Optimizing an algorithm for the identification and classification of pregnancy outcomes in German claims data.

Purpose: For studying drug utilization and safety in pregnancy based on administrative health care data, the reliable identification and classification of pregnancy outcomes in the data is essential. We aimed to optimize an existing algorithm for the identification and classification of pregnancy outcomes in the German Pharmacoepidemiological Research Database (GePaRD) with a particular focus on births.

Methods: We reconsidered all codes used by the original algorithm and applied it to data of GePaRD from 2006 to 2014.

[Prescribing valproate to girls and women of childbearing age in Germany : Analysis of trends based on claims data].

Background: Measures to raise awareness of the teratogenic potential of valproate and restrict its use in girls/women of childbearing age have been intensified. For Germany, the impact of these measures on valproate prescription rates remains unknown.

Objectives: Trends in prescribing valproate, the underlying treatment indication, and the specialty of the prescribing physician are analyzed.