A systematic review of the fetal safety of interferon alpha

Background: Interferon alpha (IFN) is an effective treatment for a variety of conditions including essential thrombocythemia (ET), chronic myelocytic leukemia, Hepatitis B and C. Because these conditions also occur in women of childbearing age who may become pregnant, information regarding the safety of this medication in pregnancy is essential. This systematic review attempts to summarize all published data on outcome of pregnancies exposed to IFN alpha, trying to differentiate between disease effect and drug effect. Methods: Reports on the use of IFN alpha in human pregnancy and reports on essential thrombocythemia (ET) without use of any medication in pregnancy were identified by a systematic search of the medical literature. We were able to locate only case reports of IFN alpha exposure in pregnancy, of whom 40 out of 63 were diagnosed with ET. We also collected randomly 71 cases (more cases were available in the literature) that were diagnosed with ET due to different etiologies, but who had not received any medication in pregnancy. Results: Among the 63 IFN alpha exposures in pregnancy, the mean maternal age was 30 +/- 6 years and the mean full term babies' weight was 3096 +/- 463g. Mean gestational age at delivery was 37 +/- 3 weeks. There were 55 single and 4 twin pregnancies. No cases of major malformations or stillbirths were reported. There was one case of spontaneous abortion and 13 preterm deliveries (20% of all exposed cases). Among the 71 cases with untreated ET in pregnancy of different etiologies, 46 (65%) had early (within the first 12 weeks of pregnancy) or late (13-20 weeks of gestation) pregnancy loss. There were also 3 cases (4%) of stillbirth and 4 cases (5.6%) of preterm delivery. Only 18 women (25%) delivered healthy term babies. Conclusions: The results of our systematic review suggest that IFN-alpha does not significantly increase the risk of major malformation, miscarriage, stillbirth or preterm delivery above general population rates. It is also possible that IFN-alpha may have a protective effect against pregnancy loss in cases of ET. Crown Copyright (C) 2011 Published by Elsevier Inc. All rights reserved.