Birth outcomes after inadvertent use of category X drugs contraindicated in pregnancy: Where is the real risk?
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Date
2018
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Abstract
Drugs contraindicated in pregnancy are medicines that should be avoided bypregnant women, since they carry a concern for teratogenicity or there is noindication for their use during pregnancy. It does not mean that exposuresto these drugs always cause harm. The aim of the present study was toinvestigate the risk of adverse outcomes following maternal exposure to thedrugs contraindicated in pregnancy. We retrospectively analyzed prenatal drugexposure records of the pregnant patients referred to the clinical pharmacologyconsultation service in a tertiary-level university hospital from January 2007until December 2012. Exposures to category X drugs (CXD) contraindicatedin pregnancy were evaluated. After the expected date of delivery, we collecteddata about pregnancy complications and the outcomes. For comparison thewomen in the exposed group (N=52) were matched with a control group(N=162) of pregnant women without teratogenic exposure. We observed onlyone baby born with a birth defect (congenital cryptorchidism) in CXD group(2.6%) and four in control group (RR 0.91; 95% CI 0.10- 7.94). The rates ofadverse pregnancy outcomes including miscarriage, preterm birth and congenitalabnormality were not significantly different from controls. However, the rateof elective termination of pregnancy was higher in women exposed to CXDwhile pregnant (RR 2.54; 95% CI 1.11- 5.80, p = 0.027). Contraceptive failureand unintended pregnancy are the reasons for inadvertent drug exposure andchoosing abortion. The high perception of teratogenic risk among pregnantwomen may cause terminations of pregnancies. Individual risk assessmentand avoiding the phrase ‘CXD’ or ‘contraindicated in pregnancy’ in counselingmay help to reduce maternal concerns about medication use in pregnancy