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Opana ER and Pregnancy

When given to pregnant rats, oxymorphone (the active ingredient in Opana ER) did not appear to increase the risk of birth defects. However, this drug may not be the best choice if you are expecting. Opana ER is a narcotic and may cause the baby to develop a dependency if you take it at the end of pregnancy. After birth, this may lead to withdrawal symptoms in your child.

Can Pregnant Women Take Opana ER?

Opana® ER (oxymorphone ER) is a prescription medication used to treat chronic pain. It is a long-acting version of oxymorphone, a narcotic drug. Based on the use of oxymorphone in animal studies, Opana ER may not be safe for use during pregnancy. However, there may be rare situations in which the benefits outweigh the potential risks.
 

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. Opana ER 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.
 
In general, most animal studies did not suggest that oxymorphone (the active ingredient in Opana ER) increases the risk for birth defects. One study suggested that the drug may increase the risk of stillbirth in rats, although other studies failed to show a similar result. That same study also showed that the drug might cause low birth weights.
 
Opana ER should not be used for pain control during labor or delivery. It is intended only for the treatment of chronic pain. If Opana ER is taken during labor and delivery, the medication may cause breathing problems in the newborn.
 
Opana ER is a narcotic, and using this drug during the end of a pregnancy may cause narcotic withdrawal in the infant after delivery. Possible withdrawal symptoms in a newborn may include:
 
  • Irritability and excessive crying
  • Shakiness (tremors)
  • Increased stools
  • Hyperactive reflexes
  • Fast breathing
  • Sneezing
  • Yawning
  • Vomiting
  • Fever.
 
However, pregnancy Category C medicines, including Opana ER, 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.
 
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