Metozolv ODT and Pregnancy

In clinical studies, giving high doses of Metozolv ODT to pregnant animals did not appear to cause any problems; limited human studies showed the same result. Based on this information, the FDA has given Metozolv ODT (orally disintegrating metoclopramide) a pregnancy Category B rating. However, the benefits and risks this drug presents should still be discussed with your healthcare provider before beginning treatment.

Is It Safe to Take Metozolv ODT While Pregnant?

Metozolv™ ODT (orally disintegrating metoclopramide) is a prescription medication sometimes used "off-label" to treat severe morning sickness (known medically as hyperemesis gravidarum).
Animal studies and limited human studies suggest that metoclopramide (the active ingredient in Metozolv ODT) is probably safe for use during pregnancy. However, it is important to stress that the medication is not approved for this use.

What Is Pregnancy Category B?

The U.S. Food and Drug Administration (FDA) uses a 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.
Even very high doses of Metozolv ODT did not cause problems in animal pregnancy studies. Limited human data also suggests that the drug probably does not cause problems during pregnancy.
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. Your healthcare provider will consider both the benefits and risks of taking this drug during pregnancy before making a recommendation in your particular situation.
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