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U.S. Department of Health and Human Services

Safety

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Ketek (telithromycin)

Audience: Infectious disease and pulmonary specialists, other healthcare professionals, consumers

[UPDATE 03/26/2007] Sanofi-Aventis issued a "Dear Healthcare Professional" letter.

[Posted 02/12/2007] FDA and Sanofi-Aventis notified healthcare professionals of revisions to the prescribing information, including a BOXED WARNING and a new Patient Medication Guide, for the antibiotic Ketek. Two of the three previously approved indications, 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 these indications. 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. The Patient Medication Guide, which must be distributed to all patients, informs them about the risks of the drug and how to use it safely.

[March 2007 – Letter – Sanofi-Aventis]
[February 12, 2007 – Press Release – FDA]
[February 12, 2007 – Label –Sanofi-Aventis]
[February 12, 2007 – Drug Information Page – FDA]

Previous MedWatch Alerts

[June 29, 2006]
[January 20, 2006]