Is cefepime (Maxipime) safe during pregnancy?

From the Guidelines

Cefepime (Maxipime) is likely safe during pregnancy.

Safety of Cefepime in Pregnancy

• Although the provided evidence does not directly mention cefepime, it discusses the safety of other cephalosporin antibiotics, such as ceftazidime, during pregnancy 1.
• The evidence suggests that cephalosporin antibiotics, in general, are safe to use in pregnancy, with no fetal damage reported in animal studies and no increased risk found in human case reports, particularly in the second and third trimesters 1.
• Given the similarity in mechanism and classification, it is reasonable to infer that cefepime, a fourth-generation cephalosporin, would also be safe during pregnancy, similar to other cephalosporins like ceftazidime.
• However, as with any medication during pregnancy, it should be used with caution and only when the benefits outweigh the potential risks, under the guidance of a healthcare provider.
• It's also worth noting that the evidence provided does not mention any specific concerns or warnings related to cefepime use during breastfeeding, but this does not necessarily imply its safety in this context without further information.

From the FDA Drug Label

Pregnancy Teratogenic Effects Pregnancy Category B Cefepime was not teratogenic or embryocidal when administered during the period of organogenesis to rats at doses up to 1000 mg/kg/day (1. 6 times the recommended maximum human dose calculated on a mg/m2 basis) or to mice at doses up to 1200 mg/kg (approximately equal to the recommended maximum human dose calculated on a mg/m2 basis) or to rabbits at a dose level of 100 mg/kg (0. 3 times the recommended maximum human dose calculated on a mg/m2 basis). There are, however, no adequate and well-controlled studies of cefepime use in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Cefepime use in pregnancy is categorized as Pregnancy Category B. While animal studies have shown no teratogenic effects, there are no adequate and well-controlled studies in pregnant women. Therefore, cefepime should be used during pregnancy only if clearly needed 2.

From the Research

Safety of Cefepime during Pregnancy

• The safety of cefepime (Maxipime) during pregnancy is a concern, and several studies have investigated its use in pregnant women 3, 4.
• A study published in the International Journal of Antimicrobial Agents measured the maternal and fetal blood levels of cefepime and found that it has a lower transplacental passage rate compared to other antibiotics 3.
• Another study published in Antibiotics (Basel, Switzerland) found that cefepime significantly decreased the incidence of surgical site infections and endometritis in women undergoing cesarean delivery 4.
• However, a systematic review and comparative analysis of reference guides for the safe use of drugs during pregnancy found that current reference guides are less scientific and reliable, and there are considerable discrepancies in recommendations from different reference guides concerning drug use during pregnancy 5.
• There is limited information on the safety of cefepime during pregnancy, and more studies are needed to fully understand its effects on the fetus and the mother.

Pharmacokinetics and Efficacy

• Cefepime has been shown to be effective in treating various infections, including pneumonia, and has a broad spectrum of antibacterial activity 6.
• The drug is generally well tolerated, with a tolerability profile similar to other parenteral cephalosporins 6.
• However, the use of cefepime during pregnancy should be carefully considered, and alternative treatments should be explored if possible.

Alternative Treatments

• Other studies have investigated alternative treatments for infections during pregnancy, such as cefixime for the treatment of syphilis 7.
• However, these studies are not directly related to the use of cefepime during pregnancy, and more research is needed to fully understand the safety and efficacy of cefepime in this population.