New Boxed Warning for Ketek Antibiotic

Lee Coleman
Lee Coleman
Contributor
Posted by Lee ColemanFebruary 13, 2007 1:43 PM

The FDA and Sandofi-Aventis notified healthcare providers of revisions to the antibiotic. Previously approved indications for bacterial sinusitis and acute bacterial chronic bronchitis were removed because the risk out weighs the benefits. It will still be used for community acquired pneumonia of mild to moderate severity. Stronger warnings were put in place for liver injury, loss of consciousness and visual disturbances. The warning states that it is also contraindicated in patients with myasthenia gravis, which is muscular weakness. Ketek came under fire last year when it was linked to liver failure and accused of failure to properly warn people of the possible problems associated with it's use.

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