Interferon beta-1b and pregnancy
Bayer’s global pharmacovigilance database contains the largest sample of exposure to interferon beta-1b before and during pregnancy available to date . Pregnancies exposed to interferon beta-1b reported to Bayer’s global pharmacovigilance database from January 1995 to February 2018 were retrieved for evaluation .
Most cases came from the US (43%) and Europe (41%). Exposure to interferon beta-1b mostly occurred in the first trimester of pregnancy .
The majority of known pregnancy outcomes of patients with exposure to interferon beta-1b were live births without congenital anomalies 
Of the 1106 live births recorded in the Bayer pharmacovigilance database, health status was known for 981 cases; the remaining 125 cases remain unknown. Of all live births with known health status, 1.4% presented with congenital anomalies . This rate was comparable to reference rates for major congenital anomalies in the US population (2.8%) and the EUROCAT database (2.4%) [1,4,5]. The rate of spontaneous abortions was also in line with the general population [1-3].
Overall, rates of reported spontaneous abortions and congenital anomalies in this large dataset were consistent with those reported in the general population [1-5].
- Hellwig K et al. Ther Adv Neurol Disord 2020; 13: 1756286420910310. Return to content
- Jones RK, Kost K. Stud Fam Plann 2017; 38(3): 187-97. Return to content
- Everett C. BMJ 1997; 315(7099): 32-4. Return to content
- European Surveillance of Congenital Anomalies (EUROCAT). Prevalence tables. Accessed on 7 December 2018. Available at: https://eu-rd-platform.jrc.ec.europa.eu/eurocat/eurocat-data/prevalence_en Return to content
- US Centers for Disease Control (CDC). Update on overall prevalence of major birth defects - Atlanta, Georgia, 1978–2005. Accessed on 7 December 2018. Available at: https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5701a2.htm. Return to content