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Embeda and Pregnancy

In studies on Embeda (morphine sulfate/naltrexone hydrochloride) and pregnancy, a number of problems occurred when the drug was given to pregnant animals. Problems seen in animal studies included decreased fetal weight, skeletal problems, and miscarriages, among others. If you become pregnant while taking this drug, your healthcare provider will weigh the benefits and potential risks before making a recommendation.

Is Taking Embeda During Pregnancy Safe?

Embeda™ (morphine sulfate/naltrexone hydrochloride) is a prescription pain medication. Based on animal studies, the drug may not be safe for use during pregnancy.
 

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 that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
Embeda contains both morphine and naltrexone. When given to pregnant animals in the second trimester, morphine increased the risk of birth defects (such as skeletal problems) and encephalopathy (brain disease or injury). Interestingly, giving male rats large doses of morphine before mating resulted in decreased litter size.
 
Animal studies also show that morphine may reversibly decrease the size of the brain, testes, and overall body weight of the offspring. Other problems seen in animal studies include slow growth, development, and sexual maturation, as well as decreased male fertility.
 
The naltrexone content of Embeda is generally of little concern, as the naltrexone is released only if the medication is taken incorrectly (if it is crushed or dissolved, such as to inject or snort the medication). In animal studies, naltrexone increased the risk of miscarriages (but did not increase the risk of birth defects).
 
Embeda is a narcotic, and using this drug during the end of a pregnancy may cause narcotic withdrawal in the infant after delivery. Such withdrawal symptoms may include:
 
  • Irritability and excessive crying
  • Shakiness (tremors)
  • Hyperactive reflexes
  • Fast breathing
  • Increased stools
  • Sneezing
  • Yawning
  • Vomiting
  • Fever.
     
There is also some thought that chronic use of opioid medications (like Embeda) during pregnancy may increase the risk of sudden infant death syndrome (SIDS).
 
However, pregnancy Category C medicines, including Embeda, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
 
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