Focalin and Pregnancy
The FDA has classified Focalin as a pregnancy Category C medication, meaning that the medication does appear to cause harm to the fetus in animal studies. When Focalin was given to pregnant rats, delayed bone formation was seen in the fetal rats. It was also noted that male baby rats gained less weight than normal. Therefore, if you are pregnant or thinking of becoming pregnant, be sure to talk with your healthcare provider about Focalin and pregnancy before taking the medication.
For people who are pregnant, Focalin® (dexmethylphenidate hydrochloride) may not be safe for use. This is based on animal studies that looked at the effects of Focalin during pregnancy.
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 was given a pregnancy Category C rating because it was shown to cause problems in pregnant animals. When Focalin was given to pregnant rats, delayed bone formation was seen in the fetal rats. Also, when Focalin was given to rats during pregnancy and breastfeeding, 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.