This just in from FDA...
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.To access complete report, click here.
