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Orap and Pregnancy

Giving Orap (pimozide) to pregnant animals appeared to increase the risk for miscarriages and impaired fetal development. Because of these risks, Orap is classified as a pregnancy Category C medication. This means that this drug should only be given to a pregnant woman when the benefits to the mother outweigh the risks to the unborn child.

Can Pregnant Women Take Orap?

Orap® (pimozide) is a prescription medication approved to treat people with Tourette syndrome who have disabling tics that have not adequately responded to other treatment. Based on the results of animal studies, Orap 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. Orap is classified as a pregnancy Category C medication.
 
Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but do appear to cause fetal harm in animal studies. In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
When given to pregnant rabbits and rats at extremely high doses, Orap did not cause any birth defects. However, it did impair fetal development in the rats and increased the risk for miscarriages in the rabbits. Orap has not been adequately studied in pregnant humans. Pregnancy Category C medicines, including Orap, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
 
Even though it is used to treat symptoms of Tourette syndrome, Orap belongs to a group of medicines known as antipsychotics. When used in the third trimester (the last three months of pregnancy), antipsychotic medicines increase the risk for movement-related symptoms (called extrapyramidal symptoms) and withdrawal symptoms in newborns. This is based on reports of symptoms in newborns whose mothers took antipsychotic medications. Reported symptoms have included:
 
  • Agitation
  • Increased or decreased muscle tone
  • Tremors
  • Sedation
  • Serious breathing problems
  • Feeding difficulty.
 
In some cases, the symptoms resolved on their own. However, in other cases, the newborns required treatment, including prolonged hospitalization or care in an intensive care unit.
 
Pregnancy and Pain

Orap Medication Information

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