| No studies were conducted to evaluate the effects of Betaseron on
fertility in normal women or women with multiple sclerosis.
No studies have been done in either animals or humans to determine
the effect of Betaseron on reproductive capacity. It is therefore, not
known whether Betaseron ® can affect human reproductive capacity.
Animal studies have been performed to determine the teratogenic effects
(abnormal development or malformations)
on the growing fetus. None were observed.
There are no adequate studies or data on
pregnancy and use of interferons in women.
Spontaneous abortion was observed in 4
patients on Betaseron trials, however, it is unknown what, if any, role
played by Betaseron ®.
Pregnant women should be advised that there
may be a risk of potential hazard to the fetus should interferon therapy
be continued. Discontinuation of therapy is advised.
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