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Cayston and Pregnancy

Cayston (aztreonam for inhalation solution) is generally considered safe to use when pregnant. The FDA has classified the drug as a pregnancy Category B medication, meaning that it does not appear to cause harm to the fetus in animal studies. However, your healthcare provider will consider the benefits and risks in your particular situation.


Can Pregnant Women Use Cayston?

Cayston® (aztreonam for inhalation solution) is a prescription medication used to treat people with cystic fibrosis. Based on animal studies, this medication is generally considered safe for use in women who are pregnant.

What Is Pregnancy Category B?

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. Cayston is classified as a pregnancy Category B medicine.
Pregnancy Category B is given to medicines that have not been adequately studied in pregnant humans but do not appear to cause harm to the fetus in animal studies. Medications that have been shown to be safe for use in pregnancy in humans but have caused problems in laboratory animals are also given a Category B rating.
Cayston contains the antibiotic aztreonam. In animal studies, high doses of aztreonam did not cause birth defects or other problems when given as an injection to pregnant rats and rabbits.
Cayston itself has not been studied in pregnant women or animals. It is important to note that this product is an inhaled antibiotic. When used as directed, very little of the drug is expected to reach the bloodstream. Therefore, blood levels of the drug after an injection (such as was used in animal studies) would be much higher than blood levels that would occur with regular Cayston use in humans.  
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category B medicine should be given to a pregnant woman only if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
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