Azmacort and Pregnancy

In animal studies involving Azmacort and pregnancy, the medication caused birth defects (such as a cleft palate and other serious malformations) when it was given to pregnant rabbits and monkeys. However, Azmacort can still be prescribed to a pregnant woman if her healthcare provider believes that the benefits outweigh any possible risks to the unborn child. If you're taking Azmacort and pregnancy occurs, let your healthcare provider know.

Is Azmacort Safe During Pregnancy?

Azmacort® (triamcinolone inhaler) may not be safe for women who are pregnant. In animal studies that looked at the effects of Azmacort during pregnancy, the drug caused birth defects.
 

Azmacort and 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.
 
Azmacort was given a pregnancy Category C rating because of potential problems in animal studies. When given to pregnant rabbits and monkeys, Azmacort increased the risk of birth defects, including a cleft palate and other serious malformations.
 
However, it is important to note that animals do not always respond to medicines in the same way that humans do. 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. Because medications like Azmacort can be essential for people with asthma, healthcare providers sometimes recommend that women continue to take Azmacort during pregnancy.
 
(Azmacort and Pregnancy Continued: Page 2)
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;
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