On June 29, 2006, the U.S. Food and Drug Administration (“FDA”) ordered the maker of Ketek to put a stronger warning on the drug's label because of its link to serious liver injury, liver failure and related liver death. According to an internal agency memo, the FDA has received reports of 12 cases of acute liver failure, including four deaths, in patients treated with Ketek. FDA safety evaluators also uncovered 23 other cases where patients suffered serious liver injuries after receiving the antibiotic. The drug, also known as telithromycin, is the first FDA-approved antibiotic of the ketolide class.

 
The symptoms most commonly associated with the Ketek side effects of liver injury, liver damage and liver failure, include:

jaundice (yellowing of the eyes and skin);

elevated liver enzyme levels;                     

abdominal pain;

severe fatigue;

dark urine;

vomiting;

nausea;

fever; 
 

In many instances where related Ketek liver damage, Ketek liver injury or Ketek liver failure occur, hepatitis or the need for a liver transplant can result. The possibility of the Ketek – hepatitis link and the Ketek – liver transplant link, was publicized by Dr. John Hanson, a physician in the liver transplant center at Carolina Medical Center (“CMC”) in Charlotte, N.C. Dr. Hanson reported on three patients being treated with Ketek at CMC, one who died after suffering liver failure, another who required a liver transplant, and a third who contracted Ketek induced hepatitis.

Ketek is most frequently prescribed for patients with chronic bronchitis, acute bacterial sinusitis, and community acquired pneumonia, including pneumonia caused by resistant strep infections. Initially, the FDA rejected applications for approval of the drug, asking for more safety information. In April of 2004, however, the FDA approved Ketek finding the drug’s benefit to the public outweighed safety concerns. In view of the agency’s recent findings, Sanofi Adventis is now being required to revise the labeling of Ketek to address the heightened concerns about Ketek’s severe side effects and potentially fatal impact. The new label will also note reported deaths in patients taking Ketek who were suffering from the neuromuscular condition, myasthenia gravis; this reflects three reported cases of related Ketek death in myasthenia gravis patients taking the drug.

 
Recently, the FDA and Sanofi have come under severe criticism from members of Congress. The reasons for this criticism include:

1) The FDA should never have approved Ketek for the treatment of mere mild to moderate respiratory infections as a Ketek side effect can be fatal and safer drugs are available.

 
2)  Many in Congress feel that both the FDA and Sanofi have concealed safety information concerning Ketek. The FDA for failing to produce information requested by Sen. Charles Grassley, R-Iowa and Sanofi for providing flawed data relating to it’s testing of Ketek.

3) The drug was approved only for use in adults and with its publicized fatal side effects, reports of Sanofi clinical trials of Ketek on children were found to be inappropriate.

4) Despite the severity of Ketek side effects, the FDA stated that it could not determine how frequently Ketek was associated with adverse events, and accordingly, the drug’s benefits continue to outweigh its risks and should remain on the market.