Ketek®
Manufacturer: Ketek (telithromycin)
Uses: Treatment of chronic bronchitis (former use); acute bacterial sinusitis (former use); and community acquired pneumonia
More Information
Ketek, the brand name for telithromycin, is the first FDA-approved antibiotic of the ketolide class. It has been used to treat acute exacerbation of chronic bronchitis; acute bacterial sinusitis and mild to moderately severe community acquired pneumonia.
When the agency first approved the drug in 2004, the risk of liver injury from Ketek appeared to be similar to that of other marketed antibiotics. However, when the product went into wider use, reports surfaced of serious liver problems in patients using Ketek.
In 2006, the FDA issued a safety bulletin about the drug after it was linked to rare cases of serious liver injury and liver failure. The FDE reported that four deaths and one liver transplant were reported following use of the drug, and the manufacturer revised the drug labeling to note these safety concerns.
In February 2007, the FDA announced that Ketek would no longer be approved to treat bacterial sinus infection and bacterial exacerbations of chronic bronchitis. The FDA also announced more "black-box" warnings.
Controversy surrounds the
clinical trials of the drug following fabrication of
data at one clinical site and allegations of
manipulation of data at another. Alabama physician Maria
Anne Kirkman-Campbell was charged in 2003 with
falsifying clinical trial data about the use of
telithromycin. She pleaded guilty to mail fraud and
received a 57-month sentence in federal prison.
If you or a loved one has developed liver problems or any of the other
serious side effects associated with the use of Ketek, call Peterson &
Associates today or
Click Here
Side Effects
- Liver failure
- Colitis
- Nausea
- Stomach pain
- Double vision
- Vomiting
- Mild diarrhea
- Headache
- Irregular or fast heartbeat
- Dizziness
- Anxiety
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