Zyflo CR and Pregnancy
In animal studies involving Zyflo CR and pregnancy, the drug was shown to cause birth defects and low birth weights. Therefore, the FDA has classified Zyflo CR as a pregnancy Category C medication, meaning the medication may not be safe to take during pregnancy. However, if a healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the fetus, he or she may still prescribe Zyflo CR.
Is Zyflo CR Safe During Pregnancy?Zyflo CR™ (zileuton CR) may not be safe for women who are pregnant. In animal studies, Zyflo CR caused problems in the fetus.
Zyflo CR and Pregnancy Category CThe 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.
When given in high doses to pregnant rats, Zyflo CR increased the risk of low birth weights and skeletal birth defects. When given to pregnant rabbits, Zyflo CR caused birth defects (such as a cleft palate). Zyflo CR has not been studied in any pregnant 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 C medicine may be given to pregnant women if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
Zyflo CR and Pregnancy: Final ThoughtsIf you are pregnant or thinking of becoming pregnant while taking Zyflo CR for asthma, let your healthcare provider know. Your healthcare provider will consider both the benefits and risks of using Zyflo CR during pregnancy before making a recommendation for your particular situation.