Noroxin and Pregnancy

Based on the results of animal studies, Noroxin (norfloxacin) is considered a pregnancy Category C medicine, meaning it may not be safe for women who are expecting. When this drug was given to pregnant animals, it increased the risk for miscarriages. Although Noroxin is not expected to cause major birth defects, a healthcare provider should only prescribe this drug if the benefits outweigh the risks.

Can Pregnant Women Take Noroxin?

Noroxin® (norfloxacin) is a prescription antibiotic. At this time, it is unknown whether Noroxin is safe for use during pregnancy. The manufacturer recommends that it only be used in pregnant women if the potential benefits outweigh the possible risks to the fetus.

What Is Pregnancy Category C?

Noroxin is classified as a pregnancy Category C drug. 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. Pregnancy Category C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
In animal studies, Noroxin did not appear to increase the risk for birth defects, although it did increase the risk for miscarriages.
Noroxin has not been thoroughly studied in pregnant women. There have been reported cases of birth defects in infants whose mothers took norfloxacin (the active ingredient in Noroxin) during pregnancy; however, one single type of defect does not appear to occur more often than others. Therefore, it is difficult to tell if norfloxacin actually caused the birth defects.
The research to date suggests that Noroxin would not substantially increase the risk for major birth defects, but there is not enough information to say it is completely safe for use in pregnancy.
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 a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child. If other, more suitable, antibiotics are not an option and Noroxin is necessary to treat an infection, the benefits of use may outweigh the potential risks.
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Noroxin Medication Information

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