Ketek: How is it possible that Ketek got approved? Before it was put into the marketplace its efficacy was questioned over and over again. Experts pointed out that the studies were plagued by fraud and negligence!
The FDA wais far from perfect when it came to Ketek.
Everything that could go wrong with Ketek. Yet, by large brush strokes of ineptitude and deceit, Ketek was approved and marketed for three indications.

Sanofi-Aventis, the drug maker, said yesterday that it planned additional discussions with the Food and Drug Administration after an advisory panel to the agency said the company should not be allowed to continue marketing the antibiotic Ketek.

The antibiotic Ketek is likely to face more safety warnings. Sanofi-Aventis’ stock for the sales of Ketek will most likely be hurt in the United States and Europe. (New Ratings)

The antibiotic Ketek, is under scrutiny amid reports of liver failure in a dozen patients. Ketek, approved in 2004, is also the subject of a Senate Finance Committee investigation because of the FDA’s handling of the approval and of possibly faulty data.

The FDA and Sanofi-Aventis, the makers of Ketek, have announced that Ketek’s labeling will now include a strong warning about serious and potentially fatal Ketek liver side effects and other serious injuries. While developing serious Ketek side effects is rare, dozens of people have been seriously injured because of this medication. (Source)

U.S. health officials said they plan to ask outside advisers in December 2006 if the antibiotic Ketek manufactured by Sanofi-Aventis should stay on the market after a dozen reports of liver failure. (Source)

An independent study of five experts says the FDA does not have the authority to pull dangerous drugs unilaterally, force changes in drug labels, or sanction drug companies that skimp on safety monitoring.
The independent study recently published its critique in the Archives of Internal Medicine. The study also contended that the FDA lacks the money and structure to insulate itself from the influence of the pharmaceutical industry. The FDA is aware of these problems and as done very little to fix them. (Washington Post)

Ketek is under fire once again, this time due to a new warning of dangerous side effects issued by Health Canada.
Telithromycin users have been shown to be susceptible to severe, perhaps life-threatening liver damage. Ketek consumers have been urged to be aware of symptoms including fatigue, jaundice, dark urine, and loss of appetite.
Health Canada recommended that patients suffering from myasthenia gravis, a chronic autoimmune condition characterized by varying degrees of weakness in skeletal (voluntary) muscles, find alternatives to Ketek.
The FDA rejected Ketek in 2001, citing risks including liver damage and blurred vision.

Some patients have experienced liver problems during or following treatment with Ketek. Rare cases of severe liver injury have been reported and have resulted in death. In myasthenia gravis patients, reports have also included life-threatening breathing trouble and death

The FDA requested more information so the drug maker hired Pharmaceutical Product Development to conduct a study known as 3014. The FDA approved Ketek knowing that some of the clinical trials involved in study 3014 were fraudulent.