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A commonly used drug has been linked to a higher risk of death in a new study.
The antibiotic, cefepime, which is used to treat bacterial infections like pneumonia, UTIs and skin infections, is typically administered via injection by healthcare providers in a clinical setting.
Severe side effects may include confusion, decreased consciousness or seizures, especially in older patients and those with kidney problems, among many other common symptoms, according to Mayo Clinic.
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New research suggests the medication may be associated with a higher risk of all-cause mortality.
The new global study, published in JAMA Network Open, reviewed 110 randomized clinical trials involving more than 22,000 patients who received cefepime or another beta-lactam antibiotic — a class of drugs that includes penicillins and cephalosporins.
Cefepime is an antibiotic used to treat bacterial infections like pneumonia, UTIs and skin infections. (iStock)
The patients included adults and children treated for febrile neutropenia — a medical emergency involving fever and dangerously low infection-fighting white blood cells — as well as pneumonia, severe bacterial infections, UTIs and meningitis.
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Across all trials, 778 deaths occurred among 11,726 patients (6.6%) given cefepime, compared to 6.2% of patients given another antibiotic. Researchers evaluated deaths from any cause occurring within about 30 days of treatment.
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Using a Bayesian meta-analysis, the researchers found a 94.4% probability that cefepime was associated with higher all-cause mortality compared with other beta-lactam antibiotics.
When the analysis was limited to 73 peer-reviewed published trials, that probability increased to 98.6%.
The association appeared stronger in adults than in children, and was most pronounced among patients treated for febrile neutropenia.
Across all trials, 778 deaths of any cause occurred among 11,726 patients (6.6%) given cefepime, compared to 6.2% of patients given another antibiotic. (iStock)
Cefepime remains a commonly used broad-spectrum antibiotic for treating serious bacterial infections in hospitalized patients because it is effective against a wide range of bacteria.
The researchers did not recommend discontinuing cefepime, but called for additional guidance and research to better understand its safety.
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The researchers said several factors could potentially explain the observed association between cefepime and higher mortality, although they were unable to identify a single cause.
Possible explanations include drug levels that are too low to effectively treat the infection and neurotoxicity, which can occur when drug levels become too high.
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Researchers said finding the right dose of cefepime can be challenging, as higher doses may improve its ability to kill bacteria while also increasing the risk of toxic side effects.
The study had several limitations. It combined clinical trials that differed in design, patient populations, dosing strategies and comparison antibiotics, with some studies dating back decades. The analysis also found an association, not proof that cefepime itself caused the higher mortality.
Finding the right dose of cefepime can be challenging, as higher doses may improve the drug’s ability to kill bacteria but also increase the risk of toxic side effects. (iStock)
Dr. Marc Siegel, senior medical analyst, said the study demonstrates the importance of re-reviewing and analyzing older studies.
“In this case, it correctly pointed out that febrile neutropenia (low white blood cell count with a fever) is itself a big cause of death in this population, making it often difficult to determine if the treatment (cefepime) decreases or possibly increases this risk,” Siegel, who was not involved in the research, told Digital.
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A closer review of the data suggests that both underdosing and overdosing — rather than the drug itself — may be more closely linked to poorer outcomes and a higher risk of death, indicating that appropriate dosing may be the key, according to the doctor.
“I also think there may be a role for AI here in determining the exact right dose, as well as assessing outcome,” Siegel suggested.
