Metadate and Pregnancy
Animal studies on Metadate and pregnancy show that the stimulant may cause problems to a developing fetus. Methylphenidate (the active ingredient) caused birth defects and slowed growth rate in baby animals that were exposed to it during pregnancy. However, animals do not always respond to drugs the same way that humans do, so your healthcare provider will consider the benefits and risks before making a recommendation.
Metadate ER® and Metadate CD® (methylphenidate extended-release) 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.
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.
Metadate was given a pregnancy Category C rating because it was shown to cause problems in pregnant animals. Methylphenidate (the active ingredient of Metadate ER and Metadate CD) has caused birth defects (including spina bifida) in rabbits. Also, when methylphenidate was given to rats during pregnancy and breastfeeding, the baby rats gained less weight than normal.
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 outweigh any possible risks to the unborn child.