Factive and Pregnancy
Based on the results of animal studies, Factive (gemifloxacin) is considered a pregnancy Category C medicine, meaning it may not be safe for women who are expecting. When extremely high doses of the drug's active ingredient were given to pregnant animals, it increased the risk for brain and eye defects. However, a healthcare provider may prescribe this drug if the benefits outweigh the risks.
Factive® (gemifloxacin mesylate) is a prescription antibiotic medication used to treat certain infections, including bronchitis and pneumonia. At this time, it is unknown if the drug is safe for use during pregnancy. The manufacturer of Factive recommends that it only be used in pregnant women if the potential benefits outweigh the possible risks to the fetus.
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 did 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.
In animal studies, giving gemifloxacin, the active ingredient in Factive, to pregnant rats, mice, and rabbits appeared to increase the risk of slow growth in the fetal animals. High doses of gemifloxacin (approximately eight times the equivalent dose in humans) increased the risk for brain and eye defects.
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 Factive is necessary to treat an infection, the benefits of using the drug may outweigh the potential risks.