Risk Factor: CM
Class: Immunologic agents/ Immunomodulators
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 0.42 mg/kg/day (13.3 million IU, 40 times the recommended human dose based on body surface area [RHD]) on gestation days 2070 (1). However, dose-related abortifacient activity occurred in these monkeys with doses of 0.0280.42 mg/kg/day (2.840 times the RHD).
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).
Breast Feeding Summary
No data are available.
- Product information. Betaseron. Berlex Laboratories, 1994.
- Hutchinson M. Pregnancy in multiple sclerosis. J Neurol Neurosurg Psychiatry 1993;56:10435.
- 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;56:10625.