Study Raises Questions Over Common Hospital Antibiotic

Clear Facts

• A new global study found a 94.4% probability that cefepime was associated with higher all-cause mortality than other beta-lactam antibiotics.
• The analysis covered 110 randomized clinical trials involving more than 22,000 patients treated for serious infections including pneumonia, UTIs, and febrile neutropenia.
• Researchers did not recommend discontinuing cefepime, but called for more research and better dosing guidance.

A major international study has linked the widely used antibiotic cefepime to a slightly higher risk of death compared to other similar drugs. The findings come from a review of 110 clinical trials involving more than 22,000 patients.

The drug is commonly given by injection in hospitals to treat serious bacterial infections such as pneumonia, urinary tract infections, skin infections, and febrile neutropenia. It belongs to the beta-lactam class of antibiotics that includes penicillins and cephalosporins.

Severe side effects can include confusion, decreased consciousness, and seizures, particularly in older patients and those with kidney problems.

New research published in JAMA Network Open found that 6.6% of patients given cefepime died within about 30 days of treatment, compared to 6.2% of patients given other beta-lactam antibiotics.

Using a Bayesian meta-analysis, the researchers calculated a 94.4% probability that cefepime was associated with higher all-cause mortality. When the analysis was limited to 73 peer-reviewed published trials, that probability rose to 98.6%.

The association appeared stronger in adults than in children and was most pronounced among patients treated for febrile neutropenia.

Researchers did not recommend discontinuing cefepime. They emphasized that it remains an effective broad-spectrum antibiotic for hospitalized patients.

Possible explanations for the observed association include drug levels that are too low to effectively treat the infection or neurotoxicity from levels that are too high. Finding the right dose can be challenging.

The study had several limitations, including combining trials that differed in design, patient populations, dosing strategies, and comparison antibiotics, with some studies dating back decades. The analysis found an association, not proof that cefepime itself caused higher mortality.

Dr. Marc Siegel, Fox News senior medical analyst, noted that febrile neutropenia itself is a major cause of death in this population, making it difficult to determine if the treatment decreases or increases that risk.

“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,” Siegel said.

“I also think there may be a role for AI here in determining the exact right dose, as well as assessing outcome,” he added.

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