Lortab and Pregnancy

In animal studies on Lortab (hydrocodone/APAP) and pregnancy, the hydrocodone component of Lortab caused birth defects when it was given to pregnant hamsters. Limited human studies also indicate that the medication may increase the risk of similar birth defects. If you are taking Lortab and pregnancy occurs, your healthcare provider will consider the benefits and risks before making a recommendation for your situation.

 

Lortab During Pregnancy: An Overview

Lortab® (hydrocodone/APAP) is a prescription pain medication that contains hydrocodone (a narcotic) and acetaminophen (Tylenol®). Based on information obtained from animal studies (and from limited human studies), the drug may not be safe for use during pregnancy.
 

Lortab 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 appear to cause harm to the fetus in animal studies but have not been adequately studied in pregnant humans. 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 hamsters, a single dose of hydrocodone (one of the components of Lortab) increased the risk of birth defects, including cranial defects. Limited human studies also indicate that Lortab may increase the risk of similar birth defects. 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
  • Fast breathing
  • Increased stools
  • Irritability and excessive crying
  • Shakiness (tremors)
  • Sneezing
  • Yawning
  • Vomiting
  • Fever.
     
However, pregnancy Category C medicines, including Lortab, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
 
(Lortab 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;