Focalin XR and Pregnancy

The FDA has classified Focalin XR as a pregnancy Category C medication, meaning that it may not be safe to take the drug during pregnancy. Focalin XR and pregnancy have not been tested together in humans, so the drug's possible effect on an unborn child is unknown. However, Focalin XR did cause problems to the fetus in pregnant animal studies. A healthcare provider may prescribe Focalin XR to a pregnant woman if its benefits outweigh the possible risks to her unborn child.

 

Focalin XR and Pregnancy -- Is It Safe?

It may not be safe to take Focalin XR® (dexmethylphenidate extended-release) while pregnant. This is based on animal studies that looked at the effects of Focalin XR during pregnancy.
 

Focalin XR 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.
 
Focalin XR was given a pregnancy Category C rating because it was shown to cause problems in pregnant animals. When Focalin XR was given to pregnant rats, delayed bone formation was seen in the fetal rats. Also, when Focalin XR was given to rats during pregnancy and breastfeeding, the male baby rats gained less weight than normal.
 
However, it is 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 her healthcare provider believes that its benefits outweigh any possible risks to her unborn child.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;