COVID-19 Latest: US FDA Approves Antibiotics For Nosocomial And Ventilatilator Associated Bacterial Pneumonia Infections During COVID-19 Crisis
: It was announce that the U S FDA has approved the antibiotic combination imipenem-cilastatin and relbactam (Recarbrio) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients aged 18 years and older. Recarbrio was previously FDA-approved to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options.
Dr Sumathi Nambiar, M.D., M.P.H., director of the Division of Anti-Infectives within the Office of Infectious Disease in FDA's Center for Drug Evaluation and Research told Thailand Medical News, "As a public health agency, the FDA addresses the threat of antimicrobial-resistant infections by facilitating the development of safe and effective new treatments," "These efforts provide more options to fight serious bacterial infections and get new, safe and effective therapies to patients as soon as possible."
Typically HABP and VABP are a type of pneumonia that occurs in hospitalized patients and can cause symptoms such as fever, chills, cough, chest pain and increased oxygen requirements.
The antibiotic Recarbrio is a combination of imipenem-cilastatin and relebactam. The drug is administered intravenously by a health care professional. The safety and efficacy of Recarbrio for the treatment of HABP/VABP were evaluated in a randomized, controlled clinical trial of 535 hospitalized adults with HABP/VABP due gram-negative bacteria (a type of bacteria) in which 266 patients were treated with Recarbrio and 269 patients were treated with piperacillin-tazobactam, another antibacterial drug. Overall, 16% of patients who received Recarbrio and 21% of patients who received piperacillin-tazobactam died through Day 28 of the study.
The common adverse reactions observed in patients treated with Recarbrio for HABP/VABP included increased aspartate/alanine aminotransferases (increased liver enzymes), anemia, diarrhea, hypokalemia (low potassium) and hyponatremia (low sodium). Before initiating therapy with Recarbrio, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams and other allergens. Recarbrio should not be used in patients who are prone to seizures and other central nervous system disorders. Clostridioides difficile-associated diarrhea has been reported with use of nearly all antibacterial agents, including Recarbrio, and may range in severity from mild diarrhea to fatal colitis.
This approval was granted as a Qualified Infectious Disease Program (QIDP) designation. This designation is given to antibacterial and antifungal drug products intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. Additionally, as part of QIDP designation, the FDA granted this application Fast Track and Priority Review designations. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
It has been observed that during the COVID-19 crisis, besides patients already being infected with the SARS-CoV-2 cor
onavirus and expressing a variety of clinical manifestations and symptoms, there was also a rise in secondary complications such as HABP and VABP among hospitalized patients and those in the ICUs under ventilators.
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