Malaria Home > Malarone and Pregnancy

The U.S. FDA has given the malaria drug Malarone (atovaquone/proguanil) a pregnancy Category C rating. This means that some risks are involved if you take it during pregnancy, but the drug can be prescribed under certain circumstances. It's important to note that malaria also poses risks to women who are pregnant. If your healthcare provider prescribes this drug during pregnancy, folate supplementation is recommended.

I'm Pregnant -- Can I Take Malarone?

Malarone® (atovaquone/proguanil) is a prescription medication used to prevent and treat malaria. It is a combination of two medicines: atovaquone and proguanil. Based on the results of animal studies, it may not be safe for pregnant women to take Malarone.

What Is Pregnancy Category C?

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 C is given to medicines that have not been studied in pregnant humans but appear to cause harm to the fetus in animal studies.
Medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
In animal studies, giving this drug to pregnant rats and rabbits did not seem to cause problems in the offspring. One of the components of Malarone, atovaquone, did not cause problems in the offspring when given to pregnant rats. However, it increased the risk for miscarriage when given to pregnant rabbits in doses high enough to cause problems in the mother rabbits.
It is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child. In some cases, the benefit of Malarone may outweigh the risks in a pregnant woman.
Malaria is especially dangerous in pregnant women and can even be life-threatening. In addition, malaria may also increase the risk for miscarriage, premature labor, or other problems in the newborn infant. Therefore, it is very important that a pregnant woman with malaria be treated.
Woman who may become pregnant should receive medication to help prevent malaria infection when traveling to a malaria area. Women should also use effective birth control while in a malaria area.
Proguanil, one of the components of Malarone, is a folate antagonist, which means it blocks the activity of folic acid. Therefore, if a pregnant woman takes Malarone, she should also take folic acid supplementation.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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