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Animal studies on Methylin and pregnancy showed that the medication could cause birth defects in babies who were exposed to the drug. Because of this, it is considered a pregnancy Category C medicine by the FDA. If you are taking Methylin and pregnancy occurs, your healthcare provider will consider the benefits and risks before making a recommendation.

Methylin and Pregnancy: An Overview

Methylin® (methylphenidate hydrochloride) may not be safe for women to take during pregnancy. This is based on animal studies that looked at the effects of the drug during pregnancy

Methylin and Pregnancy Category C

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 pregnant women or animals are automatically given a pregnancy Category C rating.
Methylin was given a pregnancy Category C rating because it was shown to cause problems in pregnant animals. For example, it has been shown to cause birth defects in rabbits.
However, it is important to note that animals do not always respond to medicines 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.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
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