Septra and Pregnancy

Is Septra Safe During Pregnancy?

Septra^® (sulfamethoxazole/trimethoprim) is a prescription antibiotic often used to treat urinary tract infections (UTIs), although it is approved for other uses as well. At this time, it is not clear if Septra is safe for use during pregnancy. The manufacturer states that pregnant women should not take Septra unless the potential benefits outweigh the risks to the fetus and that women should never take Septra near the end of pregnancy.

 

Pregnancy Category C

The U.S. Food and Drug Administration (FDA) uses a pregnancy 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 in pregnant humans but 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. A pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.

 

In animal studies, Septra increased the risk of cleft palate. Also, trimethoprim (one of the components of Septra) increased the risk of fetal death in rats. Human studies are generally lacking, although some data suggests that the risk for birth defects is probably low. It is thought that Septra might contribute to birth defects by decreasing folic acid; if it is necessary for a pregnant woman to take Septra, a folic acid supplement (at a higher-than-normal dose for a pregnant woman) might be helpful.

 

Of possibly greater concern, Septra might increase the risk of jaundice and, theoretically, kernicterus (brain damage caused by severe jaundice) in the newborn, especially if a pregnant woman takes Septra late in pregnancy.