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Small observational study: fluvoxamine not linked to rise in fetal malformation risk.(News)
MIAMI -- The use of fluvoxamine in pregnancy is not associated with an increased risk of major fetal malformations, according to preliminary results of an ongoing observational study.
Investigators compared the pregnancy outcomes of 46 women taking the selective serotonin reuptake inhibitor to treat depression with those of 46 women taking established nonteratogenic products for the same condition. Anna Sivojelezova reported in a poster presentation at the annual meeting of the American Society for Clinical Pharmacology and Therapeutics.
Fetal survival rates, birth weight, and rates of major malformations did not differ significantly between the two groups. In both groups, "we observed two major fetal malformations," said Ms. Sivojelezova of the Hospital for Sick Children in Toronto.
There were no significant differences in pregnancy outcomes between women who took fluvoxamine (Luvox) throughout pregnancy and those who took it only during the first trimester, she noted.
Because of the study's small sample size, a small increased risk for rare birth defects cannot yet be ruled out, said Ms. Sivojelezova, who, along with her colleagues, is currently recruiting more women for the study.
Currently a Food and Drug Administration category C drug in pregnancy, ...
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