FDA requires label change for Doribax; increased death risk cited

Because the antibacterial drug doripenem (Doribax; Johnson & Johnson) has demonstrated an increased risk of death and lower clinical cure rates for pneumonia than other drugs have shown, FDA has approved a new label for the medication.

Early suspension

“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 doripenem drug label that describe these risks,” FDA stated in a recent Safety
Announcement.

FDA has been concerned about doripenem, used to treat patients who develop pneumonia while on ventilators, since 2012, when the clinical trial investigating Doribax was stopped early because of “significant safety concerns.”

New information

FDA’s new analysis found that doripenem carries an increased risk of death and lower clinical cure rates compared to those of imipenem and cilastatin for injection (marketed in the United States under the name Primaxin).

“Doribax is not approved to treat any type of pneumonia, and the revised label also includes a new warning about this
unapproved use,” FDA stated. “Healthcare professionals should consider whether the benefits of Doribax treatment are likely to exceed its potential risks in patients who develop pneumonia while on ventilators.”

The numbers

In the clinical trial that was stopped early, patients with ventilator-associated bacterial pneumonia received either 7-day doripenem 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 doripenem 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, FDA stated.

However, Doribax is still considered safe and effective for its FDA-approved indications. These include treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis kidney infections. Go to http://bit.ly/doribaxlabel to view the revised Doribax drug label.