From the Guidelines
Ofloxacin is generally not recommended during breastfeeding if safer alternatives are available. While the amount that passes into breast milk is relatively small, there are theoretical concerns about potential effects on the infant's developing cartilage and joints due to ofloxacin being a fluoroquinolone antibiotic, as noted in studies such as 1. The European Respiratory Journal study 1 provides guidance on the management of reproduction and pregnancy in women with airways diseases, including the use of antibiotics during breastfeeding. Although it specifically mentions ciprofloxacin, another fluoroquinolone, the concerns about fluoroquinolones in general can be applied to ofloxacin as well.
Short-term use of ofloxacin may be acceptable in certain situations where the benefit outweighs the risk, but mothers should pump and discard breast milk during treatment and for 24-48 hours after the last dose to minimize infant exposure. No serious adverse effects have been documented in breastfed infants whose mothers took ofloxacin, but monitoring the infant for diarrhea, vomiting, or rash is advisable if exposure occurs. Safer antibiotic alternatives should be considered first, depending on the infection being treated. The concern stems from animal studies showing cartilage damage in young animals exposed to fluoroquinolones, though this effect has not been clearly demonstrated in human infants through breast milk exposure, as discussed in 1.
Key points to consider:
- Theoretical risks to the infant's developing cartilage and joints
- Short-term use may be acceptable when benefits outweigh risks
- Mothers should pump and discard breast milk during and after treatment to minimize exposure
- Monitoring for adverse effects in the infant is recommended
- Safer alternatives should be considered based on the infection being treated, as suggested by guidelines and studies such as 1 and 1.
From the FDA Drug Label
In lactating females, a single oral 200 mg dose of ofloxacin resulted in concentrations of ofloxacin in milk that were similar to those found in plasma Because of the potential for serious adverse reactions from ofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
Ofloxacin is not safe in lactating women due to the potential for serious adverse reactions in nursing infants. A decision should be made to either discontinue nursing or discontinue the drug, considering the importance of the drug to the mother 2.
From the Research
Safety of Ofloxacin in Lactating Women
- The use of ofloxacin, a fluoroquinolone antibiotic, during lactation has been studied in several research papers 3, 4.
- According to a study published in 2022, fluoroquinolones, including ofloxacin, can be considered for use during breastfeeding, as the data on exposed pregnancies have not confirmed the initial fears of toxicity 3.
- Another study from 2003 states that fluoroquinolones should not be administered as first-line treatment during lactation, but if they are indicated, breastfeeding should not be interrupted due to the low risk of adverse effects 4.
- The safety of fluoroquinolones in general has been evaluated in several studies, which have found that they are usually well-tolerated and have a low risk of adverse effects 5.
- However, it is essential to note that the use of fluoroquinolones in children is restricted due to the potential risk of joint damage and other adverse effects 5, 6.
- Studies on the safety of quinolones and fluoroquinolones during pregnancy have also been conducted, and the results suggest that they may be safe during pregnancy, although more research is needed to confirm this 6, 7.
Key Findings
- Ofloxacin can be considered for use during lactation, but it should not be the first-line treatment 4.
- The risk of adverse effects associated with fluoroquinolone use during lactation is low 4.
- Fluoroquinolones are generally well-tolerated, but their use in children is restricted due to potential adverse effects 5.
- More research is needed to confirm the safety of quinolones and fluoroquinolones during pregnancy and lactation 6, 7.