Requip XL and Pregnancy

In animal studies on Requip XL (ropinirole XL) and pregnancy, the medication decreased fetal body weight, increased fetal death, and caused birth defects of the fingers or toes. However, the drug has not been studied in pregnant humans, so it is not known if it is safe for use during pregnancy. If you are taking Requip XL and pregnancy occurs, let your healthcare provider know.

 

An Overview of Taking Requip XL During Pregnancy

Requip® XL (ropinirole XL) may not be safe for use during pregnancy. Animal studies have shown problems when the drug was given during pregnancy.
 

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 adequately 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 "default" pregnancy Category C rating.
 
In animal studies, giving ropinirole (the active ingredient in Requip XL) to pregnant rats caused decreased fetal body weight, increased fetal death, and birth defects of the fingers or toes. Requip XL has not been studied in any pregnant women.
 
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 her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
 

Final Thoughts on Requip XL and Pregnancy

If you are pregnant or thinking of becoming pregnant while taking Requip XL, let your healthcare provider know. Your healthcare provider will consider both the benefits and risks of using Requip XL during pregnancy before making a recommendation for your particular situation.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;