Aralen and Pregnancy
Although it does not have an official FDA pregnancy classification, Aralen (chloroquine phosphate) is generally considered a pregnancy Category C medication. Some animal studies indicated that the drug might increase the risk of miscarriages, eye damage, and other problems. However, this may not necessarily apply to humans, and the medicine may be prescribed if the benefits outweigh the risks.
Aralen® (chloroquine phosphate) is a prescription medication used to prevent and treat malaria infections. It is also used to treat another parasite infection called extraintestinal amebiasis. Based on the results of animal studies, it may not be safe for pregnant women to take Aralen.
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 that appear to cause harm to the fetus in animal studies.
In addition. medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Like many older medications, Aralen does not technically have an official pregnancy classification. However, many sources would consider it a pregnancy Category C drug.
In animal studies, it was shown that Aralen crosses the placenta and builds up in the eyes of the fetus, where it stayed for several months -- even after the medication was no longer present in the rest of the body. This is concerning because Aralen is known to cause serious eye problems, including permanent eye damage.
In addition, high doses of the drug given to pregnant rats caused miscarriage, as well as underdevelopment or complete absence of one or both eyes in the newborn rats.
This drug has not been studied adequately in pregnant women. The limited amount of information available on Aralen suggests that the medication does not cause a major risk to a developing fetus; however, the possibility of a small risk cannot be ruled out.
Many experts consider Aralen safe for use in pregnancy for its approved uses. However, the manufacturer recommends it only be used when the benefits outweigh the potential risks to the fetus.
A malaria infection is particularly dangerous in pregnant women and can even be life-threatening. During pregnancy, 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. In addition, a woman who may become pregnant should receive medication to help prevent infection when traveling to a malaria area.
It is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C drug 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 many cases, the benefits of Aralen use outweigh the risks in a woman who is expecting.