Suboxone and Pregnancy

When pregnant animals were given high doses of the active ingredients in Suboxone (buprenorphine and naloxone), it caused several problems in the offspring, including skeletal problems, developmental delays, and newborn death. Due to these potential risks, the FDA has classified Suboxone as a pregnancy Category C medication. However, it may be prescribed to a pregnant woman if the benefits outweigh the risks.

Can Pregnant Women Use Suboxone?

Suboxone® (buprenorphine and naloxone) is a prescription medication used to treat opioid dependence. This medication may not be safe for use during pregnancy, although the full risks are still unknown. However, it may be safer than continued use of other opioids, especially illegal ones, although methadone is usually the preferred drug in this situation.
 

What Is Pregnancy Category C?

Suboxone 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.
 
In studies with pregnant and lactating laboratory animals, high doses of buprenorphine (or buprenorphine with naloxone) increased the risk for miscarriages and newborn death. Developmental delays in the offspring, as well as minor skeletal variations were also seen.
 
The active ingredient in Suboxone 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. This will occur even if the mother breastfeeds, as the baby would receive less of the drug through breast milk than it received during pregnancy.
 
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.
 
However, pregnancy Category C medicines, including Suboxone, may be given to a pregnant woman if her healthcare provider believes that the benefits to her outweigh any possible risks to her unborn child. Although methadone is usually the preferred drug to treat opioid dependence during pregnancy (since there is more experience with using methadone in pregnant women), some early research suggests that Suboxone might have a role for this use as well.
 
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