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When given to pregnant rats, fentanyl (the active ingredient in Lazanda) was shown to increase the risk of miscarriages and decreased motor activity in the offspring. Fentanyl does pass through the placenta to an unborn child and may cause the baby to become dependent on the drug. After birth, this may lead to withdrawal symptoms, such as seizures and poor feeding.
Can Pregnant Women Use Lazanda?Lazanda® (fentanyl nasal spray) is an opioid narcotic approved to treat breakthrough cancer pain (pain that "breaks through" regularly scheduled pain medication) in people who have already been taking, and are tolerant to, opioid pain medications. It comes as a nasal spray that is sprayed into one or both nostrils, depending on the dose. 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 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.
Lazanda has not been adequately studied in pregnant women. However, fentanyl (the active ingredient in Lazanda) has been studied in pregnant animals. In these studies, the drug did not cause birth defects, but did increase the risk for miscarriage when given to pregnant rats. In addition, giving high doses to the pregnant rats via an intravenous (IV) injection during pregnancy and while breastfeeding caused delayed tooth emergence, decreased motor activity, and reduced survival rates in the offspring.
Fentanyl passes through the placenta to the developing fetus. If a pregnant woman uses fentanyl routinely throughout pregnancy, the baby may become dependent on the drug. This dependence can lead to withdrawal symptoms after birth, when the baby is no longer receiving the drug via the mother. Signs of narcotic withdrawal in the newborn may include:
- Changes in behavior, such as irritability, jitteriness, or restlessness
- Excessive or high-pitched crying
- Poor feeding
However, pregnancy Category C medicines, including Lazanda, may be given to a pregnant woman if her healthcare provider believes that the benefits of the medication outweigh any possible risks to her unborn child. If your healthcare provider recommends long-term Lazanda use during pregnancy, your baby may need to be monitored more closely after birth.