FDA Approves Label Changes for Doribax

FDA Approves Label Changes for Doribax
FDA Approves Label Changes for Doribax

The FDA has concluded that compared to the use of imipenem and cilastatin for injection (Primaxin; Merck & Co.), Doribax (doripenem; Janssen Pharmaceuticals) carries an increased risk of death and lower clinical cure rates. Doribax, an antibacterial drug, has been used to treat patients who develop pneumonia while on ventilators.

This announcement was based on data analysis from a three-year clinical trial that was halted early due to safety concerns in 2011. In this study, patients with ventilator-associated bacterial pneumonia received 7-day Doribax treatment or 10-day treatment with imipenem and cilastatin. For the Doribax group, the 28-day all-cause mortality was higher (23.0%; n=31/135) compared to the imipenem and cilastatin participants (16.7%; n=22/132). In the Doribax patients, clinical cure rates were also lower.

RELATED: Infectious Disease Resource Center

The FDA has approved changes to the Doribax drug label that describe these risks. Doribax is not approved to treat any type of pneumonia, and the revised label also includes a new warning about this unapproved use. 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 indicated for susceptible complicated intra-abdominal and complicated urinary tract infections (including pyelonephritis). It is still considered safe and effective for these approved indications.

For more information call (888) INFO-FDA or visit FDA.gov.

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