Augmentin ES and Pregnancy
In animal studies, Augmentin ES (amoxicillin/clavulanate potassium ES) did not appear to increase the risk of birth defects or miscarriages. As a result, the FDA has classified Augmentin ES as a pregnancy Category B medication. However, it is important to note that this Augmentin product is not approved for use in adults, and the full effects of this drug on a human fetus are unknown.
Can Pregnant Women Take Augmentin ES?Augmentin ES® (amoxicillin/clavulanate potassium ES) is a prescription antibiotic approved for treating ear infections in children. This medication is usually considered safe for use during pregnancy, although the full risks are not currently known. It should be noted that this particular form of Augmentin is not approved for use in adults.
What Is Pregnancy Category B?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 B is given to medicines that have not been adequately studied in pregnant humans, but do not appear to cause harm to the fetus in animal studies.
When given to pregnant rats and mice, Augmentin ES did not cause any problems. Studies have shown that this medication crosses the placenta (to the baby) in humans, but it does not appear to cause problems. Although Augmentin ES has not been systematically and adequately studied in pregnant women, case reports and surveys seem to suggest that this drug does not increase the risk of birth defects or miscarriages.
However, because Augmentin ES has not been extensively studied in pregnant women, it is possible that it may have negative effects that are currently unknown. Therefore, it 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.