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telithromycin
Ketek
  Pharmaceutical company:
Sanofi-Aventis
www.sanofi-aventis.us

NEW WARNING
The FDA issued an alert about changes to the prescribing information for the antibiotic telithromycin (Ketek). The changes include removing two of the previously approved indications: acute bacterial exacerbations of chronic bronchitis and acute bacterial sinusitis. The antibiotic should only be used for community-acquired pneumonia. The FDA has determined that the benefits of the drug no longer outweigh the risks to support the use of the drug for the other indications. They've also added a black box warning stating that the drug shouldn't be used in patients with myasthenia gravis and strengthened warnings about the risk of visual disturbances and loss of consciousness. A new Patient Medication Guide is being developed to ensure that patients are aware of the risks involved with using this drug.

     
   

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