| Rebif ® has been associated with significant increases
in spontaneous abortion in animal studies given two times the equivalent
human dose. Although there are no adequate and well-controlled studies
of Rebif ® in pregnant women, during initial pre-marketing
studies of Rebif ®, 2 spontaneous abortions were observed
and 5 fetuses carried to term among 7 women in the study groups.
Should a woman become pregnant or plan to become pregnant while taking
Rebif ®, she should be informed or the potential risk to
the fetus and discontinuation of Rebif ® therapy considered.
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