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Proquin XR and Pregnancy

It is currently unknown whether it is safe for pregnant women to take Proquin XR (ciprofloxacin hydrochloride). Pregnancy problems could potentially occur; however, since the drug hasn't been studied in humans, the full risks are unclear. In animal studies, the medication increased the risk of miscarriage and problems with fetal skeletal development.

Can Pregnant Women Use Proquin XR?

Proquin® XR (ciprofloxacin hydrochloride) is a prescription medication licensed to treat urinary tract infections, or cystitis (bladder infections). At this time, it is unknown whether Proquin XR 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?

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.
When given in high doses to pregnant rats, Proquin XR caused problems with skeletal development in the fetuses. The medication also caused fetal skeletal problems and miscarriage when given to pregnant rabbits.
Proquin XR has not been studied in pregnant women. There are reported cases of various birth defects in infants whose mothers took ciprofloxacin (the active ingredient in Proquin XR) during pregnancy. However, a specific type of birth defect does not seem to stand out. Therefore, it is difficult to tell if ciprofloxacin actually caused the problems.
To date, the research seems to suggest that Proquin XR would not substantially increase the risk for major birth defects, but there is not enough information to rule out any risk.
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.

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‣ Final Thoughts
Last reviewed by: Kristi Monson, PharmD
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