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Coartem and Pregnancy

The U.S. Food and Drug Administration classifies Coartem (artemether/lumefantrine) as a pregnancy Category C medication, which means it may not be safe for pregnant women to use this medication. Some animal studies indicated that the drug might increase the risk of miscarriages or other problems. However, this may not necessarily apply to humans, and Coartem may be prescribed if the benefits outweigh the risks.

Can Pregnant Women Take Coartem?

Coartem® (artemether/lumefantrine) is a prescription medication used to treat malaria infections. It contains two antimalarial drugs: artemether and lumefantrine. Based on the results of animal studies, it may not be safe for pregnant women to take Coartem.

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.
Medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
In animal studies, when pregnant rats received Coartem doses that were equivalent to half of the highest human dose, the medicine appeared to increase the risk for miscarriages. Also, an increased risk for miscarriages was also seen when high doses (equivalent to three times the human dose) were given to pregnant rabbits.
There is very limited information about Coartem use in pregnant women. One small study looking at the safety of this drug in pregnant women did not show an increase in birth defects or other pregnancy problems. However, this study is too small to determine whether this medication is safe for use in pregnancy.
It should be noted that a malaria infection is particularly dangerous and life-threatening in pregnant women. Malaria can also increase the risk for miscarriage and premature labor. Therefore, it is very important that a pregnant woman with malaria be treated. Coartem is not the only treatment option for malaria; however, in some cases, it may be the best option available.
It is also important to note that animals do not always respond to medicines in 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 Coartem treatment may outweigh the risks in a pregnant woman.
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Coartem Medication Information

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