AUDIENCE: Pulmonology, Infectious Disease, Pharmacy
ISSUE: The FDA has concluded that Doribax (doripenem), an antibacterial drug used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin for injection (marketed in the U.S. under the name Primaxin). Based on an FDA analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, FDA approved changes to the Doribax drug label that describe these risks. The revised label includes a new warning about this unapproved use. Doribax is not approved to treat any type of pneumonia.
BACKGROUND: 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. In the intent-to-treat population, the 28-day all-cause mortality was higher in the Doribax arm (23.0%; n=31/135) than in the imipenem and cilastatin arm (16.7%; n=22/132). Clinical cure rates were also lower in the Doribax arm.
RECOMMENDATION: Health care professionals should 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 kidney infections (pyelonephritis).
Related Safety Information:
[01/05/2012 - Statement - FDA]