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MS drug did not raise risk in pregnancy study. (Glatiramer Acetate).
HONOLULU -- A study of 345 pregnancies occurring in women taking glatiramer acetate for multiple sclerosis suggested that use of the drug results in no increased risk of adverse fetal or pregnancy outcomes.
Spontaneous abortion in users of glatiramer acetate (Copaxone) was the most common adverse fetal outcome noted in data from a clinical trial database (17% of 30 pregnancies) and postmarketing surveillance (13% of 345 pregnancies and 21% of 215 known outcomes).
These rates are consistent with the historical rate of spontaneous abortion in the general population (15%-20%), Dr. Patricia K. Coyle said at the annual meeting of the American Academy of Neurology.
A congenital anomaly was found in one of the live births among women in clinical trials. This involved a case of cleft lip that the patient's physician judged to be related to the mother's use of carbamazepine, reported Dr. Coyle of the State University of New York, Stony Brook.
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Source: HighBeam Research, MS drug did not raise risk in pregnancy study. (Glatiramer Acetate).