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FDA Ketek® – Dear Healthcare Professional Letter


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FDA Warning Letter Recall Notice On March 26, 2007, the U.S. Food & Drug Administration (FDA) issued a letter to healthcare professionals, which notified them that the use of Ketek for two of the three previously approved indications for the drug (acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis) were removed from the prescribing information because the balance of benefits and risks no longer support approval of the drug for those indications.

In addition, the letter indicated that Ketek will remain on the market for the treatment of community acquired pneumonia of mild to moderate severity. In addition, warnings were strengthened for hepatotoxicity (liver injury), loss of consciousness, and visual disturbances. The BOXED WARNING states that Ketek is contraindicated in patients with myasthenia gravis.

Additional Information:

Do I have a Ketek Lawsuit?

The Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Ketek lawsuits. We are handling individual litigation nationwide and currently accepting new Ketek side effect cases in all 50 states.

If you or a loved one have taken Ketek and developed a serious side effect, you should contact us immediately. You may be entitled to compensation and we can help.

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