Ministry of Health Expands List of Side Effects for Cefpodoxime-Containing Drugs

The Ministry’s Department for Drug and Medical Device Regulation issued a notice to manufacturers of cefpodoxime-based antibiotics (included in the Essential Drugs List). The notice requires updates to the Summary of Product Characteristics and package inserts, warning of serious, potentially fatal skin reactions. Currently, such drugs are registered in Russia by manufacturers from Turkey and North Macedonia. The update follows a letter from the National Center for Drug Expertise and Roszdravnadzor (dated December 13, 2024). New warnings must include Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), DRESS syndrome, and acute generalized exanthematous pustulosis. These conditions "may be life-threatening, including cases with a fatal outcome."