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Buprenex and Pregnancy

When high doses of the active ingredient in Buprenex (buprenorphine injection) were given to pregnant and lactating rats, it increased the risk of stillbirth, reduced offspring growth, and decreased litter size. Although no research has been done on pregnant women, a healthcare provider may still prescribe this medication during pregnancy if the benefits outweigh the risks.

Can Pregnant Women Receive Buprenex?

Buprenex® (buprenorphine injection) is an injectable narcotic pain medication approved to treat moderate-to-severe pain. This medication may not be safe for use during pregnancy, although the full risks are unknown.

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. Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans, but did appear to cause harm to the fetus 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.
Buprenex has not been adequately studied in pregnant women. In studies with pregnant and lactating rats, high doses of buprenorphine (the active ingredient in Buprenex) increased the risk of stillbirth, reduced offspring growth, and decreased litter size. It is important to note that the doses used in these studies were high enough to cause toxicity in the mother rats.
Buprenorphine passes through the placenta to the developing fetus. The chronic use of buprenorphine during pregnancy may cause the baby to become dependent on the drug. Because the baby is no longer getting the medication (via the mother) after birth, narcotic withdrawal symptoms may occur. The symptoms of narcotic withdrawal in the newborn may include:
  • Decreased respiration (decreased breathing)
  • Changes in behavior, such as irritability, jitteriness, or restlessness
  • Excessive or high-pitched crying
  • Poor feeding
  • Seizures.
The use of buprenorphine may have a role in treating opioid addiction (such as heroin addiction) during pregnancy; however, Buprenex is approved only as a pain reliever (not for addiction treatment).
However, pregnancy Category C medicines, including Buprenex, 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.
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