FDA approves use of linezolid to treat infections caused by gram-positive microorganisms in children
In December 2002, the United States Food and Drug Administration (FDA) approved the use of linezolid in the form of injections, tablets and suspensions for a new indication. Linezolid can now be used to treat children (including newborns) with infections caused by Gram-positive microorganisms, including complicated skin and soft tissue infections and nosocomial pneumonia. It is known that the frequency of detection of methicillin-resistant strains of Staphylococcus aureus (MRSA) in these infections is constantly increasing and represents a major problem for the treatment of children in hospitals and outpatients.. The FDA has also approved the use of linezolid for the treatment of community-acquired pneumonia, uncomplicated skin and soft tissue infections, and infections caused by Enterococcus faecium resistant strains. vancomycin.
Linezolid belongs to the group of oxazolidinones and has a completely new mechanism of action which prevents the production of proteins by a bacterial cell at the initial stage of synthesis, thus inhibiting the growth of bacteria.
In the United States, linezolid was approved for use in adult patients in April 2000. The high bioavailability of the oral forms of the drug facilitates the dose and allows patients to be transferred on an outpatient basis with earlier oral administration.
Dr. Sheldon Kaplan, professor in the Department of Pediatrics at the Baylor College of Medicine (United States), notes that the incidence of Gram positive infections in children with significant treatment difficulties has recently increased significantly. The use of linezolid in this group of patients will become a new, effective and safe method for the treatment of serious infections.
The results of a clinical study submitted to the FDA showed that linezolid was well tolerated and had an equivalent efficacy to vancomycin for the treatment of children from birth to 11 years old with suspected or confirmed resistant Gram positive infections. In addition to the approved indications, the drug has also been offered for the treatment of children with catheter-associated bacteremia caused by MRSA. The clinical trial of linezolid in this patient category included 1,100 children. The most common adverse events in children were fever, diarrhea and vomiting.
Since cases of myelosuppression have been reported in patients receiving linezolid, there is a need for a weekly blood test, especially patients who have been receiving the drug for more than 2 weeks have had episodes of myelosuppression, all taking medicines that can cause hemopoietic oppression or have chronic infections and have received or are currently receiving other antibacterial therapy.
Approval of linezolid for use in pediatrics is particularly important as the possibilities for treating infections caused by MRSA are growing in this category of "vulnerable" patients.