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Gatifloxacin and Pregnancy

Based on the results of animal studies, the Food and Drug Administration considers gatifloxacin a pregnancy Category C medication. This means that although the drug poses a possibility of risk to the developing fetus, it may still be prescribed provided no other suitable antibiotics are available and the benefits to the woman outweigh the risks.

Can Pregnant Women Use Gatifloxacin?

Gatifloxacin (Zymar®, Zymaxid™) is a prescription antibiotic available as an ophthalmic solution (eye drop). It belongs to a group of medications called fluoroquinolones, or "quinolones" for short. At this time, it is not known if this gatifloxacin is safe for use during pregnancy.

What Is Pregnancy Category C?

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 studied in pregnant humans but do appear to cause harm to the fetus 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.
No birth defects were observed when oral gatifloxacin was given to pregnant rats and rabbits. However, very high oral doses caused fetal heart, bone, and facial structure problems in pregnant rats. It also caused miscarriage when given in late pregnancy to pregnant rats.
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 the unborn child.
If other, more suitable, antibiotics are not an option and gatifloxacin is necessary to treat an infection, the benefits of use may outweigh the potential risks.
It is also important to point out that the amount of gatifloxacin expected to be absorbed into the blood after use in the eyes is very small. Based on this information, the medication is not thought to be particularly dangerous during pregnancy. However, because these eye drops have not been studied in pregnant women, the full risks of using gatifloxacin are not known.
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Gatifloxacin Medication Information

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