A major study links cefepime to a possible higher risk of death, but researchers say the findings do not mean patients should stop using the antibiotic.
A widely used hospital antibiotic is facing renewed scrutiny after a major analysis found a possible association between its use and a higher risk of death.
The antibiotic, cefepime, is commonly used to treat serious bacterial infections, including pneumonia, urinary tract infections, meningitis and infections associated with febrile neutropenia.
Researchers analyzed data from 110 randomized clinical trials involving 22,608 patients to examine whether cefepime was associated with differences in mortality compared with other beta-lactam antibiotics.
Study finds possible mortality signal
The analysis found that 778 of 11,726 patients who received cefepime died, representing 6.6% of that group. Among 10,882 patients who received another beta-lactam antibiotic, 674 deaths were recorded, or 6.2%.
Researchers used a Bayesian statistical approach and calculated a 94.4% probability that cefepime was associated with higher all-cause mortality than the comparison antibiotics.
When researchers restricted the analysis to 73 published, peer-reviewed trials, the probability rose to 98.6%. The pooled odds ratio in that group was 1.17.
The researchers examined deaths occurring within roughly 30 days of treatment.
Risk signal stronger among adults
The potential association was more apparent among adults than children, according to the analysis.
The researchers also found a stronger signal among patients being treated for febrile neutropenia, a potentially life-threatening condition in which a person has a fever while having abnormally low levels of infection-fighting white blood cells.
The findings were also more pronounced in studies involving severe bacterial infections and higher cefepime doses.
Cefepime is a fourth-generation cephalosporin that is valued in hospitals because it can target a broad range of bacteria, including certain difficult-to-treat infections.
Researchers do not recommend abandoning cefepime
Despite the mortality signal, the study does not conclude that cefepime should be discontinued.
Researchers emphasized that the findings show an association rather than establishing that cefepime itself caused the deaths. Patients receiving these antibiotics can be seriously ill, and underlying infections and other medical conditions can influence mortality outcomes.
Experts commenting on the analysis have also urged caution in interpreting an all-cause mortality measure because it does not necessarily reveal why a patient died.
One concern highlighted by researchers is cefepime’s relatively narrow therapeutic window. Both inadequate and excessive drug exposure could potentially affect outcomes, making appropriate dosing particularly important.
Why dosing matters
Cefepime can cause neurological side effects, particularly when drug levels become too high or when kidney function is impaired. Reported reactions can include confusion, reduced consciousness and seizures.
At the same time, giving too little antibiotic can make it more difficult to control a serious bacterial infection.
That balance is one reason the researchers called for additional investigation into dosing strategies rather than recommending that physicians abandon cefepime.
A long-running safety question
The latest analysis revisits a safety question that has surrounded cefepime for years.
Earlier research had raised concerns about a possible mortality difference, while a subsequent U.S. Food and Drug Administration analysis did not find evidence of increased mortality. The new study adds a much larger body of randomized-trial evidence to the debate.
The authors say further research is needed to determine whether the observed mortality signal is related to cefepime itself, dosing and drug exposure, or differences in the underlying illnesses affecting patients.
For patients currently receiving cefepime, the findings do not mean they should stop treatment on their own. Decisions about antibiotics, dosage and alternatives depend on the infection, kidney function, other medical conditions and the patient’s overall clinical situation.
The study ultimately highlights the importance of careful antibiotic selection and dosing while researchers continue investigating cefepime’s long-term safety profile.
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