Omeprazole During Pregnancy & Breastfeeding

by on May 14, 2012

The FDA categorizes omeprazole (Prilosec) as a category C medication, which means it should only be given during pregnancy when the potential benefit outweighs the potential risks. Category C medications are those that have had harmful effects on the fetus during animal studies and have not been adequately studied in human subjects.

Can Omeprazole be Used by Pregnant Women?

Yes, but only after the patient’s healthcare provider has weighed up the pros and cons of such an action and taken several factors into account. For example, they will need to decide if the health risks omeprazole presents are greater than the health risks associated with non-treatment of the individual’s condition.

If a doctor does decide to administer omeprazole to a pregnant patient, he or she should closely observe mother and fetus for the duration of the gestation period. Once the baby is born, he or she should be closely monitored for signs and symptoms of congenital abnormalities.

Side Effects in Pregnant Patients

Although there has been little controlled human research on the effects of omeprazole during pregnancy, some animal studies have revealed evidence of toxic effects to unborn babies. For example, when administered to pregnant rats and rabbits, the drug caused dose-related embryo and fetal mortality. A dose-dependent increase in gastric cell carcinoid tumors was also observed in rats. Despite the lack of controlled data on humans, the FDA has received individual, anecdotal reports of 11 specified birth defects following pregnancy exposure to omeprazole.

Omeprazole and Breastfeeding

Limited data suggests maternal omeprazole dosages of 20mg a day produce low levels in human breast milk. Although this would usually not be expected to cause any adverse effects in nursing infants, the patient should still consult her healthcare provider if she’s going to be breastfeeding whilst taking omeprazole. This is because in rare cases, exposure to the drug can cause the development of bilateral galactorrhea and an elevated serum prolactin in children. In cases where a healthcare provider decides against prescribing omeprazole to a nursing woman, there are alternative medications that can be considered.

If a woman becomes pregnant while she’s taking omeprazole, she should alert her healthcare provider immediately. By working together and taking all the important factors into account, the patient and healthcare provider can decide what is best for the mother and unborn child.