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Butrans and Pregnancy

If you are pregnant, Butrans (buprenorphine patch) may not be the best pain medication, as the full risks are unknown. When high doses of the active ingredient in this medication were given to pregnant and lactating rats, it increased the risk of stillbirth, reduced offspring growth, and decreased litter size. However, Butrans may still be prescribed during pregnancy if the benefits outweigh the risks.

Can Pregnant Women Use Butrans?

Butrans® (buprenorphine patch) is a prescription narcotic pain medication approved to treat moderate-to-severe chronic, persistent 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 do 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.
 
Butrans has not been adequately studied in pregnant women. In studies with pregnant and lactating rats, high doses of Butrans increased the risk of stillbirth, reduced offspring growth, and decreased litter size. It is important to note that the high doses used were high enough to cause toxicity in the mother rats.
 
The active ingredient in Butrans (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. Symptoms 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.
 
Butrans is a long-acting buprenorphine product approved for the treatment of chronic pain. It is not an appropriate choice for the treatment of pain associated with labor and delivery. The use of buprenorphine may have a role in treating opioid addiction (such as heroin addiction) during pregnancy; however, Butrans is approved only as a pain reliever, not for addiction treatment.
 
However, pregnancy Category C medicines, including Butrans, 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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