Safety-Related Labeling Changes

Based on findings in animals, Allopurinol may cause fetal harm when administered to a pregnant woman. Allopurinol and its metabolite oxypurinol have been shown to cross the placenta following administration of maternal allopurinol. Available limited published data on allopurinol use in pregnant women do not demonstrate a clear pattern or increase in frequency of adverse developmental outcomes. Among approximately 50 pregnancies described in published literature, 2 infants with major congenital malformations have been reported with following maternal allopurinol exposure. Advise pregnant women of the potential risk to a fetus.

Trade Name

Loric

Updated Section

4.6. Fertility, pregnancy and lactation

Month

Sep,2022