Ketek Label Will Get Black Box Warning and Medication Guide for Patients

FDA Limits Use of Antibiotic Ketek Community-Acquired Pneumonia

On February 12, 2007 the FDA issued a news bulletin entitled "FDA Announces Label and Indication Changes for the Antibiotic Ketek" which informed the public that Sanofi-Aventis SA's antibiotic Ketek (telithromycin) is to be prescribed only for community-acquired pneumonia, and that Ketek should no longer be prescribed for two lesser medical conditions, acute bacterial exacerbation of chronic bronchitis and acute bacterial sinusitis.

In addition, the FDA News bulletin further informed the public that the Ketek label, or package insert, will have a new black box warning added, warning doctors that patients diagnosed with myasthenia gravis, a disease which causes muscle weakness, should not be prescribed Ketek.

These actions by the FDA and Sanofi-Aventis are consistent with the recommendations made in mid-December 2006 by an FDA advisory panel, specifically that any future use of Ketek should be restricted to the treatment of community-acquired pneumonia because of the serious side effects risks associated with this controversial antibiotic.

In contrast, during June 2006 Sanofi-Aventis and the FDA announced that only a new bolded warning regarding possible liver damage would be added to the Ketek label -- instead of the black box warning that the FDA's drug safety office had recommended be added to the Ketek label, or package insert, stating that "severe, life-threatening, and in some cases fatal" liver toxicity has been reported in patients taking Ketek. This 2006 FDA staff recommendation that the Ketek-related liver injury warning be put in a black box format came after FDA safety reviewers found that Ketek had been linked to 12 cases of liver failure, including four deaths, in the U.S. through the end of April 2006.

Finally, returning to the February 2007 FDA News bulletin, the FDA announced that Sanofi-Aventis has prepared a Medication Guide for Ketek patients that will be part the Ketek label going forward.

Meanwhile, also in February 2007, there are ongoing Congressional hearings about the adequacy of the FDA's drug-safety work in which the agency's approval of this controversial antibiotic Ketek has taken center-stage.

Read more on our Ketek Information Page >>