New Package Insert, Or Label, For Ketek Will Get Black-box Warning And Medication Guide For Patients, Also
(Posted by Tom Lamb at DrugInjuryWatch.com)
In mid-December 2006 an FDA advisory panel recommended that any future use of the antibiotic Ketek should be restricted. Specifically, the panel members recommended that Sanofi-Aventis SA's antibiotic Ketek be prescribed for community-acquired pneumonia, only, and should no longer be used as treatment for acute bacterial exacerbation of chronic bronchitis nor acute bacterial sinusitis.
Two months later, by means of a February 12, 2007 FDA News bulletin entitled "FDA Announces Label and Indication Changes for the Antibiotic Ketek", we learned that the agency is going to heed this recommendation by its advisory panel.
A February 12, 2007 Reuters article by Susan Heavey provided some additional comments about the Ketek label changes from a key FDA official:
"FDA has determined that the balance of benefits and risks for Ketek do not support continued approval of Ketek for these generally nonserious and often self-limited illnesses," said Dr. John Jenkins, director of the FDA's Office of New Drugs.
Pneumonia is a more serious illness that generally does not clear up without antibiotic treatment, Jenkins said.
Ketek, known generically as telithromycin, already comes with a bold warning for possible liver damage. Jenkins said officials saw no need to strength it.
The February 2007 FDA News bulletin regarding Ketek further informed us that the Ketek package insert, or label, will get a new "black-box" warning which will advise doctors not to prescribe Ketek to patients diagnosed with myasthenia gravis, a disease that causes muscle weakness.
Finally, this February 2007 FDA News bulletin regarding Ketek previewed the new Medication Guide for patients section which will be included as part the Ketek package insert going forward.