March 2000—Aventis (now Sanofi-Aventis) submits application to sell Ketek in the United States.
June 2001—Food and Drug Administration declines to approve Ketek, citing a need for more safety information.
July 2001—Ketek approved for use in Europe.
October 2001—Sanofi-Aventis enrolls first patients for Study 3014, which is meant to test the safety of Ketek—specifically such Ketek side effects as liver failure, loss of consciousness and blurred vision.
January 2003—FDA again declines to approve Ketek, calling for more information about Study 3014 and safety reports from Europe.
April 2004—Study 3014 is proven to be full of errors, omissions and fabrications, so FDA discounts it. Still, agency approves Ketek on the basis of overseas reports and small clinical trials. It does this over the objections of Dr. David Graham of the Office of Drug Safety.
February 6, 2005—North Carolina man dies of liver failure after taking Ketek.
January 2006—European Medicines Agency asks Sanofi-Aventis to place stronger warning on Ketek label.
January 2006—Annals of Internal Medicine publishes report of three cases of liver failure in people who took Ketek; FDA confirms this information regarding Ketek side effects.
May 2006—FDA calls for black-box warning on label due to “severe, life-threatening and in some cases fatal” liver toxicity.
May 2006—Wall Street Journal story details how FDA had approved Ketek despite finding Study 3014 unreliable. Senators Charles Grassley and Henry Waxman ask questions about agency’s handling of Ketek.
June 2006—FDA issues a warning that just a few doses of Ketek can cause side effects such as liver failure.
December 15, 2006—Two FDA advisory committees say doctors should stop prescribing Ketek for less serious bacterial infections due to concerns of liver damage.