FDA Announces Label and Indication Changes Related to Dangers of Ketek
Weitz and Luxenberg is no longer accepting Ketek cases.
February 12, 2007 -- In response to the potential dangers of Ketek, the Food
and Drug Administration (FDA) today announced revisions to the labeling for the
antibiotic Ketek (telithromycin) designed to improve the safe use of Ketek by
patients. The changes include the removal of two of the three previously
approved indications -- acute bacterial sinusitis and acute bacterial
exacerbations of chronic bronchitis -- from the drug's label. The agency has
determined that 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 (acquired
outside of hospitals or long-term care facilities).
In addition, the
agency has worked with the company, Sanofi Aventis, to update the product
labeling with a "boxed warning," FDA's strongest form of warning. The warning
states that Ketek is contraindicated (should not be used) in patients with
myasthenia gravis, a disease that causes muscle weakness.
FDA also
worked with the manufacturer to develop a Patient Medication Guide -- that
informs patients about the risk of the drug and how to use it safely. The
Medication Guide (an FDA-approved patient information sheet) will be provided to
patients with each prescription.
"Today's action is the result of
comprehensive scientific analysis and thoughtful public discussion of the data
available for Ketek, and includes important changes in the labeling designed to
improve the safe use of Ketek by patients and give healthcare providers the most
up-to-date prescribing information," said Steven Galson, M.D., Director, Center
for Drug Evaluation and Research.
Other labeling changes included in
today's action are a strengthened warning section regarding specific
drug-related adverse events including visual disturbances and loss of
consciousness. Warnings for hepatic toxicity (rare but severe symptoms of liver
disease) were strengthened in June 2006.
The joint advisory committee,
which met on December 14 and 15, 2006, advised that the available data including
data acquired since the initial approval of Ketek support a conclusion that the
benefits of Ketek outweigh the risks in patients with community acquired
pneumonia, but not for patients with acute bacterial sinusitis or acute
bacterial exacerbation of chronic bronchitis. They also recommended a boxed
warning as well as Medication Guide for the drug. The joint panel consisted of
FDA's Anti-Infective Drugs and Drug Safety and Risk Management Advisory
committees.
The antibiotic Ketek was originally approved in 2004 and is
manufactured by Sanofi Aventis.
see also:
Sanofi-Aventis
Learn more about a Ketek (Telithromycin) Lawsuit and Sanofi-AventisInfo on Sanofi-Aventis, makers of harmful drug Ketek (Telithromycin)
Instructions
Instructions for taking the drug KetekKetek - the Instructions on taking the drug
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The drug Ketek (Telithromycin) can cause serious liver damage Ketek (Telithromycin) Dangers: Is your liver at risk? Learn more here.
