OBJECTIVE: We sought to examine the fetal safety of colchicine. STUDY DESIGN: This was a prospective observational comparative cohort study regarding colchicine exposure during pregnancy including contacts to 2 Teratology Information Services in Israel from 1994 through 2006. RESULTS: In all, 238 colchicine-exposed pregnancies (97.0% first trimester) and 964 pregnancies with nonteratogenic exposure were followed up. Treatment indications were: familial Mediterranean fever (87.3%), Behçet disease (7.5%), or other (5.2%). The rate of major congenital anomalies was comparable between the groups (10/221 [4.5%] vs 35/908 [3.9%]; P = .648). There were no cytogenetic anomalies in the colchicine group. The median gestational age at delivery was earlier (39 [38-40] vs 40 [38-41] weeks; P < .001), the rate of preterm deliveries was higher (32/214 [15.0%] vs 51/867 [5.9%]; P < .001), and the median birthweight was lower (3000 [2688-3300] vs 3300 [2900-3600] g; P < .001) in the colchicine group. CONCLUSION: The present study suggests that colchicine does not appear to be a major human teratogen, and, probably, has no cytogenetic effect. Copyright (c) 2010 Mosby, Inc. All rights reserved.
OBJECTIVE: We sought to examine the fetal safety of colchicine. STUDY DESIGN: This was a prospective observational comparative cohort study regarding colchicine exposure during pregnancy including contacts to 2 Teratology Information Services in Israel from 1994 through 2006. RESULTS: In all, 238 colchicine-exposed pregnancies (97.0% first trimester) and 964 pregnancies with nonteratogenic exposure were followed up. Treatment indications were: familial Mediterranean fever (87.3%), Behçet disease (7.5%), or other (5.2%). The rate of major congenital anomalies was comparable between the groups (10/221 [4.5%] vs 35/908 [3.9%]; P = .648). There were no cytogenetic anomalies in the colchicine group. The median gestational age at delivery was earlier (39 [38-40] vs 40 [38-41] weeks; P < .001), the rate of preterm deliveries was higher (32/214 [15.0%] vs 51/867 [5.9%]; P < .001), and the median birthweight was lower (3000 [2688-3300] vs 3300 [2900-3600] g; P < .001) in the colchicine group. CONCLUSION: The present study suggests that colchicine does not appear to be a major human teratogen, and, probably, has no cytogenetic effect. Copyright (c) 2010 Mosby, Inc. All rights reserved.