Zegerid OTC and Pregnancy
In animal studies, one of the active ingredients in Zegerid OTC appeared to increase the risk of miscarriages when given in high doses to pregnant rabbits. Because of this, the FDA has classified Zegerid OTC as a pregnancy Category C medicine, which means that this medication may not be safe for pregnant women.
Zegerid OTC™ (omeprazole/sodium bicarbonate) is a nonprescription proton pump inhibitor (PPI) that is used to treat frequent heartburn. It is not yet clear if this medication is safe for use during pregnancy.
The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans, but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been adequately studied in pregnant women or animals are automatically given a pregnancy Category C rating.
When given to pregnant rabbits at high doses, omeprazole (one of the active ingredients in Zegerid) increased the risk of miscarriages. However, various observational studies in humans suggest that omeprazole may be safe for use in pregnant women, although these studies may not have been sufficient to detect rare or minor problems.
A pregnancy Category C medicine should be given to a pregnant woman only if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child. If you require treatment with a heartburn medication during pregnancy, it is likely that your healthcare provider might suggest an alternative medication that is safer for use during pregnancy.
If you are pregnant or are thinking about becoming pregnant, let your healthcare provider know. He or she will consider the benefits and risks of taking this drug during pregnancy before making a recommendation on Zegerid OTC in your particular situation.