A major new analysis has found that a commonly prescribed antibiotic is linked to an increased chance of death among adults. The study looked at data from several clinical trials that varied in design and patient groups. Researchers combined results from studies that were conducted over many years, some dating back decades. The antibiotic is cefepime, a broad-spectrum beta-lactam drug often used in hospitals for serious bacterial infections.
The findings suggest a potential risk for patients treated with cefepime. The researchers noted that the study had several limitations in its approach, according to Yahoo News. These included differences in how the trials were run and the kinds of patients involved. The analysis also compared different antibiotics used in various studies. In all, researchers analyzed 110 randomized clinical trials involving 22,608 patients.
Zahra N. Sohani and Todd C. Lee were the corresponding authors of the study. The researchers emphasized that while the findings are concerning, they do not prove that cefepime directly causes death. The study also noted that many of the trials had been conducted in different countries and under varying conditions. Across all trials, 6.6% of patients who received cefepime died compared with 6.2% of patients who received another beta-lactam antibiotic.
Some patients in the studies received a different antibiotic for comparison purposes. This means that researchers had to account for many different factors when drawing conclusions. The Bayesian analysis found a 94.4% probability that cefepime was associated with higher mortality than the comparison antibiotics. When the analysis was limited to 73 published peer-reviewed trials, that probability rose to 98.6%.
The team said more research is needed to understand the full impact of this medicine on patient outcomes. They also pointed out that the risk may be higher in certain populations or with specific dosing strategies. The mortality signal was seen in adults but not children and was strongest in trials involving febrile neutropenia and severe bacterial infections. Higher cefepime doses were also associated with a greater probability of increased mortality.
The study’s authors believe their findings could influence how doctors prescribe this antibiotic going forward. The authors did not recommend that doctors stop using cefepime. Instead, they said the findings should be considered in future clinical guidance and should lead to more research on safer and more effective dosing.
The research was published in a peer-reviewed medical journal and has already sparked discussion among healthcare professionals. It appeared in JAMA Network Open on September 10. An invited commentary in the same journal argued that the problem may involve cefepime dosing rather than the drug itself.
Researchers said future work should examine whether optimized dosing can reduce the possible risk. Cefepime can cause neurotoxicity when drug levels become too high, especially in older adults, critically ill patients and people with kidney problems. The FDA label warns that serious neurological reactions including confusion, seizures and encephalopathy have occurred in patients receiving the drug. At the same time, doses that are too low may fail to provide enough exposure against some bacteria.
The findings may affect how this antibiotic is used in hospitals and outpatient settings. The study authors said cefepime still has an important role in treatment and called for a cautious assessment of its benefits and risks in each case. The overall evidence was rated as moderate certainty because of differences among the trials and possible publication bias.
Patients who have been taking this medicine should speak with their doctors about any concerns. The research does not show that patients should stop cefepime on their own. The authors said prospective studies are needed to determine whether better dosing and drug monitoring can reduce the mortality signal.
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