A recent study has linked the antibiotic cefepime to a significantly higher risk of all-cause mortality in adults compared to other beta-lactam antibiotics, raising concerns about its safety.
A new study has raised alarms regarding the antibiotic cefepime, commonly used to treat various bacterial infections. The research indicates that cefepime may be associated with a 94.4% higher probability of all-cause mortality compared to other beta-lactam drugs.
Cefepime is typically administered via injection in clinical settings to treat conditions such as pneumonia, urinary tract infections (UTIs), and skin infections. While it is effective against a wide range of bacteria, severe side effects can occur, particularly in older patients and those with kidney issues. According to the Mayo Clinic, these side effects may include confusion, decreased consciousness, and seizures.
The global study, published in JAMA Network Open, analyzed data from 110 randomized clinical trials involving over 22,000 patients who received cefepime or another beta-lactam antibiotic. The patient population included both adults and children treated for febrile neutropenia, a serious medical condition characterized by fever and critically low levels of infection-fighting white blood cells, as well as pneumonia, severe bacterial infections, UTIs, and meningitis.
Across all trials, 778 deaths were recorded among 11,726 patients (6.6%) who received cefepime, compared to 6.2% of those treated with alternative antibiotics. Researchers focused on deaths from any cause occurring approximately 30 days after treatment.
Using a Bayesian meta-analysis, the researchers determined a 94.4% probability that cefepime was linked to higher all-cause mortality compared to other beta-lactam antibiotics. When the analysis was narrowed to 73 peer-reviewed published trials, this probability increased to 98.6%. The association appeared to be stronger in adults than in children, particularly among patients treated for febrile neutropenia.
Despite these findings, cefepime remains a widely used broad-spectrum antibiotic for serious bacterial infections in hospitalized patients due to its effectiveness against a variety of bacteria. The researchers did not recommend discontinuing its use but emphasized the need for further research and guidance to better understand its safety profile.
Several factors may explain the observed association between cefepime and increased mortality, although the researchers did not pinpoint a single cause. Potential explanations include inadequate drug levels that fail to effectively treat infections and neurotoxicity, which can occur when drug levels are excessively high.
Finding the appropriate dosage of cefepime can be challenging. Higher doses may enhance its ability to combat bacteria but also raise the risk of toxic side effects. The study did have limitations, including the combination of clinical trials with varying designs, patient populations, dosing strategies, and comparison antibiotics, some of which date back several decades. Importantly, the analysis identified an association rather than proving that cefepime itself caused higher mortality rates.
Dr. Marc Siegel, a senior medical analyst at Fox News, highlighted the significance of re-evaluating older studies in light of these findings. He noted that febrile neutropenia itself is a major cause of death in this patient population, complicating the determination of whether cefepime treatment decreases or potentially increases this risk. Dr. Siegel, who was not involved in the research, suggested that both underdosing and overdosing may be more closely linked to poorer outcomes and higher mortality rates, indicating that appropriate dosing could be crucial.
He also proposed that artificial intelligence could play a role in determining the optimal dosage of cefepime and assessing patient outcomes more effectively.
As the medical community continues to evaluate the safety of cefepime, these findings underscore the importance of careful monitoring and dosage adjustments for patients receiving this antibiotic.
For more information, refer to the study published in JAMA Network Open.

