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Exalgo and Pregnancy

In studies on Exalgo (hydromorphone ER) and pregnancy, birth defects occurred when the drug was given to pregnant animals. However, it is unclear whether these problems were directly caused by the drug or other factors. If you become pregnant while taking it, your healthcare provider will weigh the benefits and potential risks before making a recommendation.

Can Pregnant Women Take Exalgo?

Exalgo™ (hydromorphone ER) is a prescription medication used to treat chronic pain. It is a long-acting version of hydromorphone, a narcotic drug. Based on the use of hydromorphone in animal studies, the drug may not be safe for use during pregnancy. However, there may be some rare situations in which the benefits of Exalgo outweigh the potential risks.

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 studied adequately 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.
When given to pregnant rats and rabbits, hydromorphone did not increase the risk of birth defects. When given to pregnant mice and hamsters, it increased the risk of a variety of different birth defects. However, it is thought that the birth defects were the result of toxicity in the mothers (due to sedation and low oxygen levels from decreased breathing), rather than a direct effect from the drug.
Exalgo should not be used for pain control during labor or delivery. It is intended only for the treatment of chronic pain and only for use in individuals who are accustomed to regularly taking significant doses of opioids. If this pain medicine is taken during labor and delivery, it may cause breathing problems in the newborn.
Exalgo is a narcotic, and using it during the end of a pregnancy may cause narcotic withdrawal in the infant after delivery. Such withdrawal symptoms can include:
  • Irritability and excessive crying
  • Shakiness (tremors)
  • Increased stools
  • Hyperactive reflexes
  • Fast breathing
  • Sneezing
  • Yawning
  • Vomiting
  • Fever.
However, pregnancy Category C medicines, including Exalgo, may be prescribed if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
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