Immunologic Agent (Immunomodulator)
PREGNANCY RECOMMENDATION: Limited Human Data—Animal Data Suggest Moderate Risk
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
Although no published reports of its use in human pregnancy have been located, the manufacturer states that spontaneous abortions occurred in four patients who were participating in the Betaseron Multiple Sclerosis clinical trial (1). The relationship between interferon beta-1b and the abortions cannot be determined, at least partially because of the lack of details involving this clinical trial, such as the timing of abortion to drug administration, the dose used, the clinical condition of the women, and the number of pregnant women in the trial. Also unknown is the effect of multiple sclerosis on early pregnancy, although it appears that the physiologic immunomodulation that occurs in pregnancy offers some protection from relapses of the disease during gestation (2,3).
FETAL RISK SUMMARY
Interferon beta-1b, prepared by recombinant DNA technology, is used for the symptomatic treatment of multiple sclerosis and investigationally in the therapy of AIDS, some neoplasms, and acute non-A/non-B hepatitis. No teratogenic effects were observed in rhesus monkeys given doses up to 40 times the recommended human dose based on BSA (RHD) on gestation days 20–70 (1). However, dose-related abortifacient activity occurred in these monkeys with doses that were 2.8–40 times the RHD.
BREASTFEEDING SUMMARY
No reports describing the use of interferon beta-1b during human lactation have been reported.
References
1.Product information. Betaseron. Berlex Laboratories, 1994.
2.Hutchinson M. Pregnancy in multiple sclerosis. J Neurol Neurosurg Psychiatry 1993;56:1043–5.
3.Roullet E, Verdier-Taillefer M-H, Armarenco P, Gharbi G, Alperovitch A, Marteau R. Pregnancy and multiple sclerosis: a longitudinal study of 125 remittent patients. J Neurol Neurosurg Psychiatry 1993;56:1062–5.