J&J Antibacterial Drug Risky For Pneumonia Patients: FDA

Law360, New York (March 6, 2014, 7:19 PM EST) -- The FDA warned Thursday that Johnson & Johnson antibacterial drug Doribax poses a higher risk of death when used in patients who develop pneumonia while on ventilators compared to other antibacterial medications, prompting changes to the warning label.

The agency said that it approved changes to the Doribax drug warning label to reflect these risks, which it said it determined through data from a three-year clinical trial that had to be halted in 2011 because of such safety risks, according to a statement Thursday. The data...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.