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The FDA has classified Concerta as a pregnancy Category C medication, meaning it does appear to cause harm to the fetus in animal studies. When Concerta was given in high doses to pregnant rabbits, it caused birth defects. Therefore, be sure to talk to your healthcare provider about the risks of Concerta and pregnancy. He or she may still prescribe Concerta if the benefits to you outweigh any possible risks to the unborn child.
Concerta and Pregnancy -- Is It Safe?For people who are pregnant, Concerta® (methylphenidate extended release) may not be safe for use. This is based on animal studies that looked at the effects of Concerta during pregnancy.
Concerta and Pregnancy Category CThe 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.
Concerta was rated a pregnancy Category C medication because it was shown to cause birth defects in rabbits. In these studies, pregnant rabbits were given very high doses of Concerta.
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 the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.