Daytrana and Pregnancy

To date, there have been no studies conducted on Daytrana and pregnancy. However, in studies of the oral version of methylphenidate (the active ingredient in Daytrana), the medication caused birth defects when given to pregnant rats. Because of this, Daytrana has been given a pregnancy Category C classification by the FDA; however, a doctor may still prescribe Daytrana for a woman who is pregnant -- if the doctor believes that the benefits to the woman outweigh the potential risks to the unborn child.

 

Is It Safe to Take Daytrana During Pregnancy?

Daytrana™ (methylphenidate patch) may not be safe for use in women who are pregnant. While there have not been any studies conducted specifically on the effects of taking Daytrana during pregnancy, oral forms of methylphenidate (the active ingredient in Daytrana) have been shown to have adverse effects in studies of pregnant animals.
 

Daytrana and Pregnancy Category C

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.
 
Daytrana has never been studied in pregnant women or animals. However, it was given a pregnancy Category C rating based on studies using the oral version of methylphenidate. In these studies, large doses of methylphenidate caused birth defects when given to pregnant rats, and decreased the weight and survival of the baby rats.
 
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 pregnant women if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
 
(Daytrana and Pregnancy Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;