MFDS "Ceftezol Sodium, Efficacy Not Proven... Use Suspension Recommended"

Food and Drug Safety Ministry CI
Photo by Food and Drug Safety Ministry

The Ministry of Food and Drug Safety (MFDS) announced on the 30th that it has distributed a drug information letter recommending the discontinuation of the use of ceftezol sodium injection in medical practice and the use of alternative drugs, stating that "clinical trial re-evaluation results showed that ceftezol sodium injection did not demonstrate effectiveness compared to other antibiotics for complicated urinary tract infections and pyelonephritis."

Ceftezol sodium is an antibiotic that exhibits antibacterial effects by inhibiting bacterial growth through interference with bacterial cell wall synthesis. Currently, Shinpung Pharmaceutical manufactures it under the brand name 'Shinpung Ceftezol Sodium Injection,' and Samjin Pharmaceutical sells it as 'Setrazol Injection' as prescription drugs.

The MFDS stated that after reviewing the re-evaluation data and consulting the Central Pharmaceutical Review Committee, ceftezol sodium injection was assessed as having "no safety issues," but "failed to prove efficacy and effectiveness." Although domestic clinical trials were conducted by related companies to re-examine and evaluate the safety and efficacy of the drug, the results showed that it did not demonstrate effectiveness compared to other antibiotics used for the indicated conditions.

Accordingly, the future deletion of the relevant indications for ceftezol sodium will be decided through objection procedures under the drug re-evaluation regulations. The MFDS explained that "this suspension and other measures are proactive actions taken ahead of administrative procedures."

In the drug information letter, the MFDS requested cooperation from medical and pharmaceutical professionals to use alternative drugs for patients with complicated urinary tract infections and pyelonephritis, and urged patients with these conditions to consult with their healthcare providers. Additionally, cooperation measures were requested from the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service to ensure caution when administering this drug in hospitals and clinics.