Oramorph and Pregnancy
In animal studies on Oramorph SR (morphine sulfate ER) and pregnancy, the medication appeared to cause several problems, such as skeletal problems and brain disease. Due to these potential risks, the FDA has classified Oramorph SR as a pregnancy Category C medication. However, Oramorph SR may be prescribed to a pregnant woman if her healthcare provider believes the benefits outweigh the risks.
Oramorph® SR (morphine sulfate ER) is a prescription pain medication. It contains long-acting morphine, a narcotic drug. Based on the use of morphine in animal studies, the drug may not be safe for use during pregnancy. However, there may be rare situations in which the benefits outweigh the potential risks.
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 "default" pregnancy Category C rating.
When given to pregnant animals, morphine (the active ingredient of Oramorph SR) caused problems. These problems included an increased 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 a smaller litter size, possibly suggesting an effect on fertility. Animal studies also show that morphine may 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.
Oramorph SR is not recommended for pain control during labor or delivery. Not only can it slow down the progression of labor; it may also cause breathing problems in the newborn.
Oramorph SR is a narcotic, and using this drug during the end of a pregnancy may cause narcotic withdrawal symptoms in the infant after delivery. Such withdrawal symptoms may include:
- Irritability and excessive crying
- Shakiness (tremors)
- Increased stools
- Hyperactive reflexes
- Fast breathing
However, pregnancy Category C medicines, including Oramorph SR, 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.