The controversial, much-scrutinized antibiotic Ketek is under fire once again, this time due to a new warning of dangerous side effects issued by Health Canada. Some users of Ketek (or telithromycin) 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 has strongly 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. In response, Sanofi-Aventis commissioned a rather dubious study of the drug that suffered from falsified data, inappropriate subjects, criminal doctors, and significant violations of the study's guidelines.
Though that study was rejected-and a subsequent clinical trial was rife with inaccuracies-an FDA advisory panel pushed for Ketek's approval in 2003. Although the full FDA declined approval that year, they reversed their decision the following year. The controversy has ignited calls from medical professionals and congressmen for more stringent standards in the FDA's approval of pharmaceuticals. More than 5 million patients have taken Ketek since the FDA's approval two years ago. (News)
