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• W1986014592 abstract "To the Editor: We appreciate the interesting study by Yazdy et al1 on the association of pregnancy exposure with selective serotonin-reuptake inhibitors (SSRIs) and risk of congenital clubfoot. However, we believe that there are several points to consider before drawing clinical inferences of their study. The authors attribute a remarkable degree of precision to the dose and timing (a specific lunar month) of exposure, and argue that the risk of recall bias is likely low due to the fact that SSRI treatment is chronic and continuous. Although to some extent plausible and supported by some studies, this assumption is subject to controversy. In a large case–control setting, recall bias was documented to elevate odds ratio (OR) toward spurious associations.2 The participation rate was 9% higher for cases than to controls, which could induce a falsely elevated OR if exposed cases are more likely to participate compared with exposed controls. In fact, the authors themselves address this limitation in another study derived from the same cohort and specifically state that mildly elevated ORs are likely affected by this.3 The prevalence of SSRI exposures in this study is remarkably low compared with population estimates. The authors quote rates between 5% and 16%, whereas a recent large-scale population-based US study found an exposure rate of 6.7%.4 This clearly contrasts with the reported exposure rate in the control group of 3%, whereas the exposure rate of 5% among cases appears more concordant with population estimates. In our opinion, this substantial discrepancy compromises the external validity of the study. We have performed an analysis of the complete Danish population data based on the cohort reported by Jimenez-Solem et al.5 From 1997 to 2012, 1,036,121 women gave birth to 1771 children with a diagnosis of clubfoot (ICD-10 Q66.0). Among 19,258 first-trimester SSRI-exposed women, 44 were born with a clubfoot. This corresponds to an adjusted (year, age, education, household income, parity, smoking, and body mass index) OR of 1.32 (95% confidence interval: 0.88, 1.97). In conclusion, we hold the opinion that the results from Yazdy et al cannot justifiably be extrapolated outside the specific setting. We find it unsubstantiated that first-trimester exposure to SSRIs is associated with a true and clinically meaningful elevated risk of clubfoot. We do not believe that this result should be disseminated to patients or be a factor in health care professionals’ decisions on SSRI treatment during pregnancy. Daniel Pilsgaard Henriksen, MD, PhD Department of Clinical Chemistry & Pharmacology Odense University Hospital Odense, Denmark [email protected] Anton Pottegård, MSc Pharm, PhD Clinical Pharmacology Institute of Public Health University of Southern Denmark Odense, Denmark Espen Jimenez-Solem, MD, PhD Department of Clinical Pharmacology Bispebjerg and Frederiksberg Hospital Copenhagen, Denmark Per Damkier, MD, PhD Associate Professor Department of Clinical Chemistry & Pharmacology Odense University Hospital Odense, Denmark Clinical Pharmacology Institute of Public Health University of Southern Denmark Odense, Denmark" @default.
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• W1986014592 date "2015-05-01" @default.
• W1986014592 modified "2023-10-12" @default.
• W1986014592 title "In Utero SSRI Exposure and Risk of Clubfoot" @default.
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• W1986014592 doi "https://doi.org/10.1097/ede.0000000000000276" @default.
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