Xodol and Pregnancy

In clinical studies on Xodol and pregnancy, the drug increased the risk of skull defects when given to pregnant animals. The same risk may also be present in humans. As a result, the FDA considers Xodol a pregnancy Category C drug. If you become pregnant while taking it, contact your healthcare provider right away.

 

Xodol During Pregnancy: An Overview

Xodol™ (hydrocodone/APAP) is a prescription pain medication. Although the benefits of the drug may outweigh the risks in certain situations, Xodol is usually not recommended for pregnant women.
 

Xodol and 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 default pregnancy Category C rating.
 
A single dose of hydrocodone (one of the components of Xodol) increased the risk of birth defects, including cranial (skull) defects when given to pregnant hamsters. Limited studies also suggest that Xodol may increase the risk of similar birth defects in humans. In addition, hydrocodone 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:
 
  • Hyperactive reflexes
  • Irritability and excessive crying
  • Fast breathing
  • Shakiness (tremors)
  • Increased stools
  • Sneezing
  • Yawning
  • Vomiting
  • Fever.
     
However, pregnancy Category C medicines, including Xodol, 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.
 
(Xodol and Pregnancy Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;