Pregnancy outcomes from the global pharmacovigilance database on interferon beta-1b exposure

Abstract

Background: The goal of the present cohort study was to review outcomes of patients exposed to interferon beta-1b during pregnancy. Methods: Pregnancy cases with exposure to interferon beta-1b reported to Bayer’s pharmacovigilance (PV) database from worldwide sources from January 1995 through February 2018 were retrieved for evaluation. Only cases where pregnancy outcomes were unknown at the time of reporting (i.e. prospective cases) were included in the analysis of this retrospective cohort study. Results: As of February 2018, 2581 prospective pregnancies exposed to interferon beta-1b were retrieved from the database; 1348 pregnancies had documented outcomes. The majority of outcomes [1106 cases (82.0%)] were live births. Health status was known for 981 live births (no known health status for 125). Most of the prospective pregnancies with known outcomes corresponded to live births with no congenital anomalies [896 cases (91.3%)]. Spontaneous abortion occurred in 160 cases (11.9%). Congenital birth defects were observed in 14/981 live births with known health status [1.4%, 95% confidence interval (CI) 0.78–2.38]. No consistent pattern in the type of birth defect was identified. Rates of both spontaneous abortion and birth defects were not higher than the general population. Conclusions: These PV data, the largest sample of interferon beta-1b-exposed patients reported to date, suggest no increase in risk of spontaneous abortion or congenital anomalies in women exposed during pregnancy.

Prevalence of adverse pregnancy outcomes after exposure to interferon beta prior to or during pregnancy in women with MS: Stratification by maternal and newborn characteristics in a register-based cohort study in Finland and Sweden

“…Previous observational studies [9][10][11][12][13][14][15][16][17][18] and a large post-authorisation safety study (PASS) [19] in women with MS have reported no increase in the prevalence of adverse pregnancy outcomes after exposure to IFN-beta before or during pregnancy. Data from Finland, however, suggest that the prevalence of elective terminations for reasons other than foetal anomaly may be increased among pregnant women exposed to IFN-beta [19].…”

The risk of polypharmacy, comorbidities and drug–drug interactions in women of childbearing age with multiple sclerosis

“…13 A recent pharmacovigilance data analysis by Hellwig et al revealed that the use of interferon beta-1b until conception and in the first pregnancy trimester is not linked to an increased risk of abnormal pregnancy outcomes compared with the general population. 63 Nevertheless, in general, caution is required when using DMDs in pregnant women or in women of childbearing age.…”

Clinical Features and Maternal-fetal Results of Pregnant Women in COVID-19 Times

“…According to the United States Center for Disease Control and Prevention (CDC), health professionals should follow some recommendations when performing obstetric procedures in pregnant patients with confirmed or suspected COVID-19 diagnosis, from prehospitalization to discharge of the mother and baby. [51][52][53][54][55][56][57][58][59][60] It is worth mentioning that, in Brazil, the diagnosis in pregnant women must follow the same protocol for the general adult population and that attention should be paid to the signs and symptoms that demonstrate clinical severity. 46 Prehospital care includes notification of the obstetrics unit for the proper delivery room preparation, for the correct use of personal protective equipment (PPE) by the health professionals involved and conduct in accordance with biosafety rules.…”