The rates of major malformations after gestational exposure to isotretinoin: a systematic review and meta-analysis
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ObjectiveIsotretinoin is among the most notorious human teratogens, documented originally as causing up to 30% ofmalformations. This systematic review and meta-analysis aimed to evaluate the rates of major malformation (MM)among isotretinoin-exposed pregnant women over the years through a systematic review and meta-analysis. MethodsEligible studies were searched and identified using various databases. Single-arm meta-analysis and meta-analysis ofodd ratios among controlled studies were performed using Review Manager version 5.3. ResultsTen eligible studies that combined 2,783 isotretinoin-exposed women were included in our study. The rate of MMweighted for the sample size was 15%. Three studies that included an unexposed comparison group were eligible forthe meta-analysis. The pooled odds ratio of MM for isotretinoin-exposed women was 3.76. After 2006, the pooledodds ratio of MM for isotretinoin exposure was significantly lower at 1.04. ConclusionThe current rate of MM in isotretinoin-exposed women was substantially lower after 2006.
Abstract
ObjectiveIsotretinoin is among the most notorious human teratogens, documented originally as causing up to 30% ofmalformations. This systematic review and meta-analysis aimed to evaluate the rates of major malformation (MM)among isotretinoin-exposed pregnant women over the years through a systematic review and meta-analysis. MethodsEligible studies were searched and identified using various databases. Single-arm meta-analysis and meta-analysis ofodd ratios among controlled studies were performed using Review Manager version 5.3. ResultsTen eligible studies that combined 2,783 isotretinoin-exposed women were included in our study. The rate of MMweighted for the sample size was 15%. Three studies that included an unexposed comparison group were eligible forthe meta-analysis. The pooled odds ratio of MM for isotretinoin-exposed women was 3.76. After 2006, the pooledodds ratio of MM for isotretinoin exposure was significantly lower at 1.04. ConclusionThe current rate of MM in isotretinoin-exposed women was substantially lower after 2006.
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