Safety Signal Detection for Antihypertensive Drug-Induced Cleft Lip and/or Palate and Evaluation of Risk Perception for Medication Use in Pregnancy Among Mothers With Children With Cleft Lip and/or Palate

Background: Cleft lip with or without cleft palate (CL±P) is one of the most prevalent birth defects with wide variability across geographic origin, racial and ethnic groups and an overall incidence ranging between 0.03% and 0.2%. Maternal drug consumption is one of the implicating factors that have been associated with the development of CL±P. Hypertensive disorders occur in an estimated 5-10% of pregnancies and at least 5% of women take antihypertensive treatment during gestation. More than 90% of pregnant women take prescription or non-prescription drugs at some time during gestation. Perception of risk could highly influence a pregnant woman's decision to whether use a drug or not especially when taking over the counter medications.;Aims: 1) To study a possible association between anti-hypertensive drugs taken during pregnancy and CL±P incidence in a group of cases and controls. 2) To evaluate the perception of risk for medication use during gestation between mothers who gave birth to children with cleft lip and/or palate and mothers with children without the malformation.;Methods: For the first part of the study a retrospective chart review of women in Tufts Medical Center was performed while for the second part a structured questionnaire was used. Both parts involved a case and a control group.;Results: For the first part of the study no women in the case group were under antihypertensive treatment. For the second part of the study both case and control groups overestimated the risk of medication use in gestation.;Conclusions: For the first part of the study no association between antihypertensive medication and the development of CL±P could be identified. For the second part, no statistically significant association between groups was detected. However, both groups overestimated the risk of drug usage in pregnancy.