Ritalin SR and Pregnancy
In animal studies on Ritalin SR and pregnancy, fetuses that were exposed to the drug were born with birth defects and low birth weight. As a result, the FDA has classified Ritalin SR as a pregnancy Category C medication. However, animals may respond to medicines differently than humans. If you are taking Ritalin SR and pregnancy occurs, your healthcare provider will weigh the benefits and risks before making a recommendation.
Ritalin SR® (methylphenidate extended-release) may not be safe for use in women who are pregnant. This is based on animal studies that looked at the effects of the drug during pregnancy.
The U.S. Food and Drug Administration (FDA) uses a 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 that 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.
Ritalin SR was given a pregnancy Category C rating because it was shown to cause birth defects in rats and rabbits. Also, giving the drug to pregnant rats caused low birth weight in the baby rats.
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 mother outweigh any possible risks to the unborn child.
If you are taking Ritalin SR and pregnancy occurs, or if you are thinking about becoming pregnant while taking the drug, let your healthcare provider know. He or she will consider the benefits and risks of using the drug during pregnancy before making a recommendation for your particular situation.