Abstract
BackgroundDespite their widespread use the effects of taking benzodiazepines and non-benzodiazepine hypnotics during pregnancy on the risk of major congenital anomaly (MCA) are uncertain. The objectives were to estimate absolute and relative risks of MCAs in children exposed to specific anxiolytic and hypnotic drugs taken in the first trimester of pregnancy, compared with children of mothers with depression and/or anxiety but not treated with medication and children of mothers without diagnosed mental illness during pregnancy.MethodsWe identified singleton children born to women aged 15–45 years between 1990 and 2010 from a large United Kingdom primary care database. We calculated absolute risks of MCAs for children with first trimester exposures of different anxiolytic and hypnotic drugs and used logistic regression with a generalised estimating equation to compare risks adjusted for year of childbirth, maternal age, smoking, body mass index, and socioeconomic status.ResultsOverall MCA prevalence was 2.7% in 1,159 children of mothers prescribed diazepam, 2.9% in 379 children with temazepam, 2.5% in 406 children with zopiclone, and 2.7% in 19,193 children whose mothers had diagnosed depression and/or anxiety but no first trimester drug exposures. When compared with 2.7% in 351,785 children with no diagnosed depression/anxiety nor medication use, the adjusted odds ratios were 1.02 (99% confidence interval 0.63–1.64) for diazepam, 1.07 (0.49–2.37) for temazepam, 0.96 (0.42–2.20) for zopiclone and 1.27 (0.43–3.75) for other anxiolytic/hypnotic drugs and 1.01 (0.90–1.14) for un-medicated depression/anxiety. Risks of system-specific MCAs were generally similar in children exposed and not exposed to such medications.ConclusionsWe found no evidence for an increase in MCAs in children exposed to benzodiazepines and non-benzodiazepine hypnotics in the first trimester of pregnancy. These findings suggest that prescription of these drugs during early pregnancy may be safe in terms of MCA risk, but findings from other studies are required before safety can be confirmed.
Highlights
Mental illness is among the leading causes of disability in the United Kingdom (UK) [1]
There were 19,193 (5.1%) children born to women with diagnosed depression or anxiety but with no first trimester medication and 3,218 (0.9%) with first trimester exposure to anxiolytic or hypnotic drugs, of which 1,175 children (36.5%) had concurrent exposure to antidepressants (65.5% of which were SSRIs)
Women prescribed anxiolytic/hypnotic drugs were more likely to be from socioeconomically deprived groups than women with depression/anxiety un-medicated in early pregnancy (Table 2)
Summary
Mental illness is among the leading causes of disability in the United Kingdom (UK) [1]. Since the Thalidomide scandal [5], the potential for teratogenic effects of drugs has been a pressing concern for all women of childbearing age and prescribers Due to their widespread use there has rightly been a research focus on maternal perinatal mental health [6] and its potential effects on children born to women taking antidepressants, mood stabilisers and antipsychotic drugs [7]. Very few studies have examined the effect of individual drugs or assessed the impacts of underlying health conditions and concurrent medications [8]. Despite their widespread use the effects of taking benzodiazepines and non-benzodiazepine hypnotics during pregnancy on the risk of major congenital anomaly (MCA) are uncertain. The objectives were to estimate absolute and relative risks of MCAs in children exposed to specific anxiolytic and hypnotic drugs taken in the first trimester of pregnancy, compared with children of mothers with depression and/or anxiety but not treated with medication and children of mothers without diagnosed mental illness during pregnancy
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