Can Pregnant Women Take Ofloxacin?

Based on the results of animal studies, the Food and Drug Administration considers Ofloxacin a pregnancy Category C medication. This means that although the drug is generally not recommended for use in pregnant woman, it could be prescribed if the benefits to the woman outweigh the possible risks to the unborn child. This might occur if other, more suitable antibiotics are not available. In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.

Ofloxacin(CAS NO:82419-36-1) can cause retarded ossification and arthropathy in young animals, but there is no published information about its teratogenicity in humans. A 36-year-old woman was treated with ofloxacin 200 mg bid for 6 days during the 19th week of gestation. 

Research indicates that Ofloxacin(CAS NO:82419-36-1) can rapidly cross the blood-placenta and blood-milk barrier, and are extensively distributed into the fetal tissues. Peak concentration in human breast milk is similar to levels attained in plasma. Breast-feeding mothers who take ofloxacin may expose their infants to severe adverse reactions.

Other flouroquinolones have also been reported as being present in the mother’s milk and are passed on to the nursing child, which may increases the risk of the child suffering from this syndrome as well, even though the child had never been prescribed or taken any of the drugs found within this class.

The data on the safety of the fluoroquinolones in pregnancy contains conflicting reports and is to be considered incomplete due to the lack of adequate studies. But it should be noted that several studies have reported spontaneous abortions following the exposure to the fluoroquinolones during pregnancy, as well as therapeutic/elective abortions due to the perceived, as well as actual, risk of birth defects.

However, within one study the authors concluded that the use of quinolones during pregnancy may in some cases be necessary; e.g. drug resistant serious infections, but if safer antibiotics such as penicillin, cephalosporins or erythromycin are an option they should be used instead due to their clearer safety profile.

Ultrasound follow-up of the measurements and structure of the fetal long bones revealed no abnormalities. The neonate's physical examination and X-rays of the chest and long bones were normal. Although no teratogenic or toxic effects were observed in this patient, the use of ofloxacin in human pregnancy should only be a clinical consideration until sufficient evidence regarding its safety in the human fetus has been published.

Ofloxacin is a prescription antibiotic used to treat a variety of bacterial infections. It is available as a tablet, an ophthalmic (eye) solution, and an otic (ear) solution. Ofloxacin belongs to a group of medications called fluoroquinolones, or "quinolones" for short. At this time, it is not known if Ofloxacin is safe for use during pregnancy. 

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