WASHINGTON — Label changes on Doribax (doripenem), an antibacterial drug used to treat ventilator-associated pneumonia, have been approved by the Food and Drug Administration.
The FDA said the drug carries an increased risk of death and lower clinical cure rates compared with use of imipenem and cilastatin for injection, marketed in the United States under the name Primaxin.
“Based on our analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, we have approved changes to the Doribax drug label that describe these risks,” the agency noted.
The revised label also includes a new warning about unapproved use of Doribax, which is only approved to treat certain types of pneumonia. The FDA said that, before using it, healthcare providers should carefully consider whether the benefits of Doribax treatment are likely to exceed its potential risks in patients who develop pneumonia while on ventilators.
Doribax is still considered safe and effective for its FDA-approved indications — treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis.
In the clinical trial that was stopped early, patients with ventilator-associated bacterial pneumonia received either 7-day Doribax treatment or 10-day treatment with imipenem and cilastatin. Results indicated that the 28-day all-cause mortality was higher in the Doribax arm (23%; n=31/135) than in the imipenem and cilastatin arm (16.7% ; n=22/132). Clinical cure rates also were lower in the Doribax arm.