Bestazol 50/Bestazol 100 Use In Pregnancy & Lactation

Use in Pregnancy: FDA pregnancy category C.
Reproduction studies have been conducted with cilostazol in rats and rabbits. In pregnant rats, 1000 mg/kg/day dose resulted in decreased fetal weights and an increased incidence of congenital malformations in the cardiovascular, renal and skeletal systems. Increased incidences of ventricular septal defects and retarded ossification were also observed at 150 mg/kg/day. This same dose administered to rats in late pregnancy was associated with stillbirths and decreased birth weight. In pregnant rabbits, a dose of 150 mg/kg/day was associated with an increased incidence of retarded ossification of the sternum.
No reports describing the use of cilostazol during human pregnancy have been located. The drug is teratogenic and toxic in two animal species, but the complete lack of human data prevents any assessment of the risk that cilostazol presents to a human fetus.
Use in Lactation: No reports describing the use of cilostazol during human lactation have been located. The drug is excreted into the milk of lactating rats. This is consistent with the relatively low molecular weight (about 369) of the drug and excretion into breast milk should be expected. The effect on a nursing infant from exposure to cilostazol in milk is unknown. Because of the potential for severe adverse effects, breastfeeding while receiving cilostazol is not recommended.