Kalydeco and Pregnancy
When given in high doses to pregnant rats and rabbits, Kalydeco (ivacaftor) did not appear to cause problems in the offspring. Because this medicine is probably safe for use during pregnancy, the Food and Drug Administration classifies it as a pregnancy Category B medicine. Even so, this product should only be given to a pregnant woman if the benefits outweigh the risks.
Can Pregnant Women Take Kalydeco?Kalydeco™ (ivacaftor) is a prescription cystic fibrosis medication. At this time, it appears that Kalydeco is probably safe for use during pregnancy.
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. Kalydeco 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.
In studies, even when Kalydeco was given in high doses, it did not appear to cause problems in pregnant rats and rabbits. 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.