FDA Says Unapproved Pneumonia Drug Doribax Will Undergo Label Change

The Johnson & Johnson drug Doribax (dorpenem) will undergo label changes to warn of an increased risk for death in patients with ventilator-associated pneumonia, the US Food and Drug Administration (FDA) announced.

The new label will reflect findings from a 3-year clinical trial of doripenem in ventilator-associated pneumonia that was terminated early due to safety concerns. “Doribax is not approved to treat any type of pneumonia, and the revised label also includes a new warning about this unapproved use,” the FDA said.

The FDA noted that “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 called pyelonephritis.”

In the study, patients with ventilator-associated bacterial pneumonia were either given a 7-day course of doripenem or a 10-day course of imipenem and cilastatin for injection. Clinical cure rates were 11.2% lower in the Doribax arm of the studycompared to patients in the alternative group.

Compared with use of imipenem and silastatin (Merck’s Primaxin), the FDA said doripenem “carries an increased risk of death and lower clinical cure rates.” They also warn that health care professionals should consider whether the benefits outweigh the risks in patients who develop pneumonia while on ventilators.