Taking Tylox During Pregnancy: An Overview
Tylox® (
oxycodone/APAP) is a prescription pain medication. Based on animal studies and limited data from human studies, the drug may not be safe for use during pregnancy. Pregnant women should take Tylox only if the potential benefits for pain control outweigh the possible risks to the fetus.
Tylox 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 pregnancy Category C rating.
Although Tylox has not been studied in pregnant humans or animals, the individual components (
oxycodone and
acetaminophen) have been. Acetaminophen is considered fairly safe for use during pregnancy
(see Tylenol and Pregnancy).
When given to pregnant animals, oxycodone did not seem to increase the risk of birth defects or other problems. Limited human studies also suggest that oxycodone does not seem to cause birth defects in humans. However, oxycodone 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, despite the apparent risks, pregnancy Category C medicines, including Tylox, 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.
