Normal pregnancy outcome following inadvertent exposure to rosiglitazone, gliclazide, and atorvastatin in a diabetic and hypertensive woman

Reprod Toxicol. 2004 Jun;18(4):619-21. doi: 10.1016/j.reprotox.2004.02.014.


The subject is a diabetic and hypertensive woman treated early during an unplanned pregnancy with a multi-drug regimen that included three drugs with no prior history for use in pregnant women (rosiglitazone, gliclazide, atorvastatin). She was under care for chronic hypertension, which she suffered for 14 years, and diabetes mellitus, hypercholesterolemia, anxiety disorder, morbid obesity and epilepsia for 5 years. She was exposed to rosiglitazone (4mg/day), gliclazide (60mg/day), and atorvastatin (40mg/day) in addition to acarbose, spironolactone, hydrochlorothiazide, carbamazepine, thioridazine, amitryptiline, chlordiazepoxide, and pipenzolate bromide during the first 7 weeks of gestation while unaware of pregnancy. Pharmacotherapy was adjusted following clinical recognition of pregnancy during the 8th week. She gave birth to a normal healthy infant at the 36th week of gestation. This is the first reported case of human exposure to rosiglitazone, gliclazide, and atorvastatin during pregnancy. Although the normal pregnancy outcome does not address the safety of these drugs for use in pregnancy, these data contribute to a limited knowledge regarding human exposure to these antidiabetic drugs.

MeSH terms

  • Adult
  • Anxiety Disorders / complications
  • Apgar Score
  • Atorvastatin
  • Chronic Disease
  • Diabetes Complications / drug therapy*
  • Epilepsy / complications
  • Female
  • Gliclazide / adverse effects*
  • Gliclazide / therapeutic use
  • Heptanoic Acids / adverse effects*
  • Heptanoic Acids / therapeutic use
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / adverse effects*
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use
  • Hypercholesterolemia / complications
  • Hypertension / complications*
  • Hypoglycemic Agents / adverse effects*
  • Hypoglycemic Agents / therapeutic use
  • Infant, Newborn
  • Obesity, Morbid / complications
  • Pregnancy
  • Pregnancy Complications, Cardiovascular / physiopathology*
  • Pregnancy Outcome
  • Pyrroles / adverse effects*
  • Pyrroles / therapeutic use
  • Rosiglitazone
  • Thiazolidinediones / adverse effects*
  • Thiazolidinediones / therapeutic use


  • Heptanoic Acids
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Hypoglycemic Agents
  • Pyrroles
  • Thiazolidinediones
  • Rosiglitazone
  • Atorvastatin
  • Gliclazide