In
January 2006 researchers reported three cases of severe liver injury (hepatoxicity)
following the use of Ketek.
Except for having bacterial infections in the lungs and
sinuses, all patients were healthy prior to taking Ketek.
Patient #1 died from liver failure only two weeks after taking Ketek for five
days. Patient #2 required a liver transplant after using Ketek.
Patient #3 developed drug-induced hepatitis after taking Ketek but later
recovered.
Ketek is in a class of drugs called ketolide antibiotics; its
pharmaceutical name is telithromycin (teh lih throw MY sin).
Ketek fights bacteria in the body.
Ketek is used to treat bacterial infections in the lungs and sinuses.
Ketek may also be used for purposes other than those listed in the medication
guidelines.
Food & Drug Administration issues the following Ketek side effects advisory:
The Annals of Internal Medicine published an article reporting three
patients who experienced serious liver toxicity following administration of
Ketek (telithromycin). Ketek is marketed and used extensively in many other
countries, including Europe and Japan. While it is difficult to determine the
actual frequency of adverse events from voluntary reporting systems such as the
MedWatch program, the FDA is continuing to evaluate the issue of liver problems
in association with use of Ketek in order to determine if labeling changes or
other actions are warranted. As a part of this, FDA is continuing to work to
understand better the frequency of liver-related adverse events reported for
approved antibiotics, including Ketek.
While the FDA continues its Ketek liver injury
investigation, here are some recommendations to healthcare providers and
patients:
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Healthcare providers should monitor patients taking Ketek for signs or
symptoms of liver problems. The ketolide antibiotic should be stopped in
patients who develop symptoms of liver problems.
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Patients who have been prescribed Ketek and are not experiencing side effects
such as jaundice should continue taking their medicine as prescribed unless
otherwise directed by their healthcare provider.
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Patients who notice any yellowing of their eyes or skin or other problems like
blurry vision should contact their healthcare provider immediately.
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As with all antibiotics, Ketek should only be used for infections caused by a
susceptible microorganism (bacterial). Ketolide antibiotics are not effective in
treating viral infections, so a patient with a viral infection should not
receive Ketek since they would be exposed to the risk of side effects without
any benefit.
The antibiotic Ketek is manufactured by Sanofi-Aventis SA and was approved for
the U.S. market by the Food and Drug Administration (FDA) in April 2004 to treat
acute bacterial bronchitis, sinusitis, and pneumonia.
The antibiotic Ketek has been linked to liver failure. Have you been
prescribed or are you presently taking Ketek? Have you suffered Ketek side
effects and liver damage? You may qualify for a Ketek lawsuit.
For a free no-obligation consultation, please contact our personal injury Ketek
lawyers.
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