> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Merck’s Recarbrio OK’d for Hospital Pneumonia
- URL: https://www.fdaweb.com/mercks-recarbrio-okd-for-hospital-pneumonia/
- Published: 2020-06-04T12:00:00.000Z
- Updated: 2026-09-14T16:17:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146940

FDA has approved a Merck NDA for Recarbrio (a combination of imipenem-cilastatin and relebactam) to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years of age and older. The drug was previously approved to treat patients with complicated urinary tract infections and complicated intra-abdominal infections who have limited or no alternative treatment options. HABP and VABP occur in hospitalized patients and can cause symptoms such as fever, chills, cough, chest pain and increased oxygen requirements.

Approval was based on data from a randomized, controlled clinical trial of 535 hospitalized adults with HABP/VABP due gram-negative bacteria. During the trial, 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,” an [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-antibiotic-treat-hospital-acquired-bacterial-pneumonia-and-ventilator-associated?ref=fdaweb.com) says.

The most common adverse reactions observed included increased aspartate/alanine aminotransferases (increased liver enzymes), anemia, diarrhea, hypokalemia and hyponatremia. “Before initiating therapy with Recarbrio, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams and other allergens,” the agency says.