Is Tramadol Safe During Pregnancy?
Tramadol hydrochloride (
Ultram®) is a prescription pain medication. Based on animal studies (and limited human use), the drug may not be safe for use during pregnancy.
Tramadol and Pregnancy Category C
The U.S. Food and Drug Administration (FDA) uses a 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.
When given to pregnant mice, rats, and rabbits,
tramadol caused the following problems:
- Decreased fetal weight
- Skeletal problems, such as extra ribs
- Delayed development in the offspring
- Miscarriages (but only at doses high enough to be toxic to the pregnant animals themselves).
Tramadol has been studied as a medication used to control labor pain, compared to
morphine or
meperidine (
Demerol®). Some studies showed that tramadol was safer for the babies (less likely to cause breathing problems), but other studies showed no differences between the medications. Tramadol is not approved for this use.
This medication crosses the placenta in humans. There have been reports of problems possibly due to
tramadol use during pregnancy in humans, including miscarriages and stillbirths. Also, chronic use of the drug during pregnancy can result in
tramadol withdrawal in the newborn, including symptoms such as:
However, pregnancy Category C medicines such as tramadol 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.
