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.

Posted by Michael Monheit at 11:34 AM | Permalink

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

Posted by Michael Monheit at 06:19 AM | Permalink

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.

Posted by Michael Monheit at 06:17 AM | Permalink

Ketek was finally approved in April 2004 for the adult treatment of acute bacteria infections from chronic bronchitis, acute bacterial sinusitis and community-acquired pneumonia. Ketek has been linked to extremely serious adverse reactions.

Posted by Michael Monheit at 06:18 AM | Permalink