Ketek Lable and Usage Changes

RLF Staff

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FDA has removed two of the three previously approved indications for the antibiotic Ketek (telithromycin). This drug is no longer indicated for acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. FDA deleted the two indications because the benefits of using the drug in these cases do not outweigh its risks. The one remaining FDA-approved indication is for the treatment of mild to moderate community-acquired pneumonia due to certain specific organisms in patients 18 years and older.

Ketek's new labeling will also contain a boxed warning stating that the drug is contraindicated in patients with myasthenia gravis. Some patients who took Ketek have experienced serious respiratory effects, and some of them have died. Warnings about hepatotoxicity in patients taking Ketek were added in June 2006.

Stronger warnings are also included about the possibility of visual disturbances and loss of consciousness. Because of this, patients on Ketek should avoid potentially hazardous activities such as driving or operating heavy machinery. A new Patient Medication Guide with information about the risks of Ketek and how to take it safely will be provided to patients with each prescription.

For more information from the FDA, visit http://www.fda.gov/medwatch/safety/2007/safety07.htm#Ketek