Objective: To report a case of exposure to gliclazide and ramipril during pregnancy in a patient with diabetes mellitus and hypertension.
Case summary: A 42-year-old female with type 2 diabetes mellitus and hypertension who had been taking gliclazide 30 mg/day and ramipril 10 mg/day for 2 years was admitted in the 16th week of gestation. The following week, gliclazide and ramipril were discontinued and methyldopa 500 mg 4 times daily and intensive insulin therapy were instituted. Blood glucose concentrations and blood pressure remained within acceptable levels throughout the pregnancy. The patient gave birth to a healthy child (3200 g) by cesarean section after completing an uneventful gestation period.
Discussion: Oral antidiabetic drug use in pregnancy is not recommended secondary to known effects on the fetus such as congenital abnormalities, fetal hyperinsulinemia, macrosomia, and neonatal hypoglycemia. Although this infant had no abnormalities after being exposed to gliclazide and ramipril during the first 16 weeks of gestation, this case is not an unconditionally acceptable indication for safety of these medications in pregnancy. Angiotensin-converting enzyme inhibitors increase fetal risks and therefore should not be used during pregnancy, according to data from animals and humans. There are few data available on use of sulfonylureas; thus, their use should also be avoided during pregnancy.
Conclusions: Although the normal pregnancy outcome in our patient does not indicate that use of gliclazide and ramipril is safe during gestation, these data contribute to limited information regarding human exposure to these drugs.