FDA Adds Black Box Label for Ketek

Allison Snoddy

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Monday the FDA announced that it was changing the label for the popular antibiotic drug Ketek. It has striped away two previously approved indications and added a black box warning. A black box warning is the FDA's strongest warning. The drug can no longer be used for treatment of acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. The FDA determined that the "balance of benefits and risks no longer support approval for the drug for these indications."

Keteck is now only approved for the treatment of mild to moderate cases of pneumonia acquired outside hospitals or long-term care facilities. The black box warning will state that Keteck should not be used in patients with myasthenia gravis (it causes muscle weakness). The label also references visual disturbances and loss of consciousness have also been increased. Last June the label was changed to warn about toxicity to liver.

I am interested in seeing if lawsuits come about regarding the use of this drug prior to the label changes. What have been the effects on people that were previously using it? What are the long term effects? Should this drug be taken off the market completely? There are so many questions that only time will tell.