Is ceftaroline (Cefaroline, a cephalosporin antibiotic) safe for use during pregnancy?

From the Guidelines

Ceftaroline can be used in pregnancy when the potential benefits outweigh the risks, but it should not be considered a first-line agent, as evidenced by the lack of direct information on its safety in the provided studies 1. The provided studies do not directly address the safety of ceftaroline during pregnancy, but they do discuss the safety of other antibiotics and the general principles of antibiotic use in pregnancy. According to the study published in the European Respiratory Journal in 2020 1, cephalosporins, such as cefuroxime, are considered to be not teratogenic at usual therapeutic doses, which may imply that ceftaroline, as a cephalosporin, could be safe. However, the study also discusses the importance of considering the potential benefits and risks of each medication, and choosing alternatives with more established safety profiles when possible. The study published in the same journal in 2020 1 provides a summary of the Therapeutic Goods Administration (TGA) and Food and Drug Administration (FDA) categories for drug use during pregnancy, but does not specifically mention ceftaroline. Another study published in Rhinology in 2016 1 recommends the use of penicillin and cephalosporin as the safest classes of antibiotics during pregnancy, but does not provide specific information on ceftaroline. Given the lack of direct information on ceftaroline, it is recommended to use ceftaroline during pregnancy only when the potential benefits outweigh the risks, and to consider alternative antibiotics with more established safety profiles first. The typical adult dose of ceftaroline is 600 mg administered intravenously every 12 hours for 5-14 days, depending on the infection being treated, with dose adjustments needed for patients with renal impairment. Close monitoring of both mother and fetus is recommended if ceftaroline is used during pregnancy. It is also important to note that ceftaroline is a fifth-generation cephalosporin that works by binding to penicillin-binding proteins to inhibit bacterial cell wall synthesis, and has activity against many resistant organisms, including MRSA.

From the FDA Drug Label

1. 1 Pregnancy Risk Summary There are no adequate studies with Teflaro in pregnant women that informed any drug associated risks. The background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies within the general population In developmental toxicity studies conducted in animals, no malformations or other adverse developmental effects were observed in offspring of rats exposed to Teflaro at up to 4 times the maximum recommended human dose (MRHD) during the period of organogenesis through lactation In rabbits exposed to Teflaro during organogenesis at levels approximately equal to the MRHD, no drug-induced fetal malformations were observed despite maternal toxicity.

The safety of ceftaroline during pregnancy is unknown due to the lack of adequate studies in pregnant women. Although animal studies did not show any adverse developmental effects, the results cannot be directly applied to humans. Therefore, ceftaroline should be used during pregnancy with caution and only if the benefits outweigh the potential risks 2.

• Key points:
  • No adequate studies in pregnant women
  • Animal studies showed no adverse developmental effects
  • Use with caution if benefits outweigh potential risks
  • Background risk of major birth defects is 2-4% and miscarriage is 15-20% in the general population

From the Research

Safety of Ceftaroline during Pregnancy

• There is limited information available on the safety of ceftaroline during pregnancy, as stated in the study 3.
• The study 3 recommends avoiding the use of ceftaroline during pregnancy due to the absence of relevant data.
• None of the other studies 4, 5, 6, 7 provide information on the safety of ceftaroline during pregnancy.

Adverse Effects of Ceftaroline

• The known adverse effect profile of ceftaroline is similar to that of all cephalosporins, and comprises hypersensitivity reactions (including anaphylaxis) and gastrointestinal disorders (including rare cases of pseudomembranous colitis), as reported in the study 3.
• A possible excess of haematological and renal adverse effects has also been raised, according to the study 3.
• The study 4 states that ceftaroline is well tolerated, with adverse events similar to those of standard therapy, and generally mild in nature.
• The study 6 notes that ceftaroline's safety profile is similar to that of the other cephalosporins, with minimal adverse drug reactions, most of which are considered mild.

Efficacy of Ceftaroline

• Ceftaroline has been shown to be effective in the treatment of complicated skin and soft tissue infections and community-acquired pneumonia, as reported in the studies 4, 5, 6, 7.
• The study 4 states that ceftaroline is noninferior to vancomycin plus aztreonam in treating complicated skin and skin structure infections caused by both Gram-positive and -negative pathogens.
• The study 5 notes that ceftaroline provides an additional option for the management of complex multidrug resistant infections, including MRSA.