In animal studies on Plaquenil (hydroxychloroquine) and pregnancy, the medication crossed the placenta and accumulated in the eyes of the fetus when it was given to pregnant animals. Although human studies are lacking, available evidence suggests a relatively low risk to the fetus. If you are taking Plaquenil and pregnancy occurs, your healthcare provider will weigh the benefits and potential risks before making a recommendation.
An Overview of Using Plaquenil During Pregnancy
Plaquenil® (hydroxychloroquine sulfate) is a prescription anti-malarial medication that is also used to treat lupus and rheumatoid arthritis. In many cases, the benefits of using Plaquenil for malaria prevention or treatment in pregnant women outweigh the risks. The Centers for Disease Control lists Plaquenil as one of the medications that can be used during pregnancy for malaria treatment or prevention.
Plaquenil and 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. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Technically, Plaquenil does not have an official pregnancy Category rating, as is common with older medications. However, most sources consider it to be a pregnancy Category C medication.
In animal studies, it was shown that Plaquenil crosses the placenta and accumulates in the eyes of the fetus and remains there for several months. This raises serious concerns, since Plaquenil is known to cause permanent eye damage. Human studies are lacking, but available evidence generally suggests a relatively low risk to the fetus. In many cases, the possible benefits for malaria prevention or treatment greatly outweigh the possible risks. This may not be true for other Plaquenil uses (such as for treating lupus or rheumatoid arthritis).
If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. He or she will consider both the benefits and risks of Plaquenil during pregnancy before making a recommendation for your particular situation.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation. 7th ed. Philadelphia (PA): Lippincott Williams & Wilkins;2005.
Centers for Disease Control and Prevention. Information for healthcare providers: preventing malaria in the pregnant woman (10/13/2005). CDC Web site. Available at: http://wwwn.cdc.gov/travel/contentMalariaPregnantHC.aspx. Accessed July 17, 2008.
Centers for Disease Control and Prevention. Treatment of malaria (guidelines for clinicians) (3/2007). CDC Web site. Available at: http://www.cdc.gov/malaria/pdf/clinicalguidance.pdf. Accessed July 17, 2008.
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