Finacea and Pregnancy
In studies on pregnant animals, Finacea (azelaic acid gel) did not appear to cause birth defects. As a result, the FDA has classified the drug as a pregnancy Category B medication. However, the full risks of using it during pregnancy are not known, and the medication should only be prescribed if the benefits to the woman outweigh the possible risks to the unborn child.
Can Pregnant Women Use Finacea?Finacea® (azelaic acid gel) is a prescription skin medication used for the treatment of rosacea. Based on information from animal studies, this drug does not appear to be particularly dangerous during pregnancy, although the possible risks to humans are largely unknown at this time.
What Is Pregnancy Category B?The United States 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 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.
In addition, 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, high doses of azelaic acid (the active ingredient in Finacea) given to pregnant animals by mouth did not cause birth defects. However, some toxicity to embryos was seen, but only at doses high enough to cause toxicity in the mothers as well.
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 the healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
Importantly, applying Finacea does not appear to increase the blood levels of azelaic acid beyond the normal range (it is normal to find azelaic acid in the blood, as this compound is found naturally in wheat, barley, and rye). Because only small amounts of the drug are absorbed into the bloodstream, there is minimal risk to a developing fetus.