Edgar Snyder & Associates®
A Law Firm Representing Injured People
1-866-943-3427
Call Us Toll Free 24/7
Published on Jul 19, 2006 by Edgar Snyder

FDA Officials Disagreed with Ketek Approval

Ketek

A Food and Drug Administration (FDA) debate is heating up over the safety of the antibiotic, Ketek. According to internal FDA e-mails, Ketek’s approval was a mistake and the drug should be taken off the market immediately.

An FDA spokeswoman reassured that every issue or question raised during Ketek’s trial and afterward was reviewed by the nation’s top doctors both internally and externally. However, several e-mails have appeared stating that many safety officials within the FDA expressed serious concern with the antibiotic.

Since Ketek’s approval in 2004:

  • 14 adults suffered liver failure
  • Four of the fourteen died
  • others suffered serious liver injury

Although Ketek’s label has been changed to include a warning about severe liver damage, it is still is available for use. This is despite suggestions by officials to remove the antibiotic from the market.

Drug litigation may involve co-counsel.

Source: “Approval of Antibiotic Worried Safety Officials.” By Gardiner Harris. New York Times. July 19, 2006.
Think you have a case?
Think you have a case?
Free Case Review
First Name
Last Name
ZIP
Phone
Email
Briefly describe your injuries

Recent News

Sep 28, 2016
Pittsburgh Police Beefing Up DUI Patrols in 2017
Sep 26, 2016
Gear Up, Cool Down, and Stay Safe While Riding This Fall
Sep 16, 2016
Fall and Winter Car Kit
Sep 16, 2016
A New Law May Be Coming for Drivers
Sep 16, 2016
Smartphone Apps for Drivers
Tweet