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Nucynta ER and Pregnancy

Animal studies have shown that when Nucynta ER (tapentadol ER) is taken during pregnancy, it may cause birth defects, delayed skeletal formation, and even fetal death. Although it is unknown if these problems would occur in humans, talk to your healthcare provider before taking this drug while pregnant. Because it is a narcotic, Nucynta ER may also cause withdrawal symptoms in a newborn.

Can Pregnant Women Take Nucynta ER?

Nucynta® ER (tapentadol ER) is a narcotic opioid medication. It is approved for the treatment of chronic moderate-to-severe pain. It is also approved to treat diabetic nerve pain that requires continuous, around-the-clock treatment. Based on the results of animal studies, there may be some risks associated with the use of this medication during pregnancy.

What Is Pregnancy Category C?

Nucynta ER is classified as a pregnancy Category C drug. 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 adequately studied in pregnant humans but have caused 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.
During animal studies, some birth defects, such as cleft palate and gastroschisis, occurred, along with other problems, such as delayed skeletal formation and higher fetal and newborn mortality. It is unknown if these complications would occur in humans, as animal studies do not always reflect what will occur in humans.
In addition, Nucynta ER is a narcotic, and chronic use of the drug during the end of a pregnancy may cause narcotic withdrawal in the infant after delivery. Some of the possible withdrawal symptoms may include:
  • Hyperactive reflexes
  • Fast breathing
  • Irritability and excessive crying
  • Shakiness (tremors)
  • Increased stools
  • Sneezing
  • Yawning
  • Vomiting
  • Fever.
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Nucynta ER Drug Information

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