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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.

Can Pregnant Women Take Zegerid OTC?

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.
 

What Is Pregnancy Category C?

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.
 
Esomeprazole is an isomer of omeprazole, which is found in Zegerid OTC. When esomeprazole was given to pregnant rats at high doses, fewer offspring survived after birth. The surviving pups had developmental delays, abnormal bone growth, and poor weight. Also, pregnant and nursing rats that were given high doses of esomeprazole lost bone mass, which is consistent with the possible effects of the drug on calcium absorption (it can decrease calcium absorption).
 
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.
 
Pregnancy and Pain

Zegerid OTC Medication Information

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