Is Symbicort Safe During Pregnancy?
Symbicort® (
budesonide and formoterol) may not be safe for women who are pregnant. In animal studies that looked at the effects of Symbicort during pregnancy, the drug caused birth defects and increased the chance of miscarriage.
Symbicort 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 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.
Symbicort was given a pregnancy Category C rating because of potential problems demonstrated in animal studies. When given to pregnant rats, the drug caused birth defects and increased the risk of miscarriage.
However, it is important to note that animals do not always respond to medicines in the same way as humans. A pregnancy Category C medicine may be given to a pregnant woman if a healthcare provider believes that the benefits to her outweigh any possible risks to the unborn child. Because medications like Symbicort can be essential for people with
asthma, healthcare providers sometimes recommend that women continue to take Symbicort during pregnancy.