Apr 032014
FDA Warning on Doripenem (Doribax) for VAP

In March 2014, the FDA issued a warning statement against Doribax (doripenem) for ventilator associated pneumonia, saying:

Doribax carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin ... Doribax is not approved to treat any type of pneumonia.

(Doripenem is approved for intra-abdominal infections and complicated UTIs, like pyelonephritis.)

The FDA adds:

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.

This was all based on a randomized trial that was stopped early when all cause mortality was higher with Doribax than with Primaxin (imipenem-cilastatin) (23% vs 17%), and clinical cure rates were also lower among patients treated with doripenem.

The product label for doripenem has been updated to include the new warning. Many hospitals have chosen Doribax as their preferred formulary carbapenem, and automatically substitute imipenem or meropenem to doripenem, unless you specify otherwise. Ask your ICU's pharmacist to be sure.

"FDA approves label changes for antibacterial Doribax (doripenem) describing increased risk of death for ventilator patients with pneumonia", FDA website.

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FDA warns against doripenem (Doribax) for ventilator-associated pneumonia