Quillivant XR and Pregnancy

The FDA has classified Quillivant XR (methylphenidate ER oral suspension) as a pregnancy Category C medication, meaning that it may not be safe to take the drug during pregnancy. During animal studies, this medication caused several problems, such as birth defects and reduced weight gain in the newborn animals. However, a healthcare provider may still prescribe it during pregnancy if the benefits outweigh the risks.


Can Pregnant Women Take Quillivant XR?

Quillivant XR™ (methylphenidate ER oral suspension) is a prescription stimulant medication used in the treatment of attention deficit hyperactivity disorder (ADHD). Based on animal studies, this medication may not be safe for use during pregnancy.

What Is 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. Quillivant XR is classified as a pregnancy Category C medication.
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.
In animal studies, Quillivant XR increased the risk for birth defects when given to pregnant rats and rabbits in high doses. More specifically, it increased the risk for spina bifida, a defect of the spinal column, in rabbits and bone abnormalities in rats. In addition, the medication reduced weight gain in the rat offspring when given to the mother rats throughout pregnancy and while breastfeeding.
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, including Quillivant XR, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
This drug has not been adequately studied in pregnant women. However, stimulant medicines (like Quillivant XR) appear to increase the risk for premature birth and low birth weight when taken by women during pregnancy.
In addition, because the drug may pass to the developing infant in the womb, babies whose mothers took stimulants during pregnancy may be at risk for withdrawal symptoms after birth. Therefore, it is recommended that such infants be monitored for symptoms of withdrawal, such as:
  • Difficulties with feeding
  • Irritability
  • Agitation
  • Excessive drowsiness.
Pregnancy and Pain

Quillivant XR Drug Information

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