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Reports State That Bronchitis Drug Ketek May Cause Liver Failure
The Food and Drug Administration (FDA) announced
on
June 29, 2006, that they ordered the
makers of Ketek to put a stronger warning on the drug labels because
of its link to serious liver injury, liver failure and death. The
FDA has
received reports of 12 cases of acute liver failure, including four
deaths, in patients treated with Ketek, according to an internal
agency memo. FDA safety evaluators also uncovered 23 other cases
where patients suffered serious liver injuries after receiving the
antibiotic, also called telithromycin.
When the internal memo was leaked to the public, French drug
manufacturer Sanofi Aventis confirmed on May 19 that it was in
discussion with the USDA about its antibiotic Ketek after the USDA
wanted a warning label put on the drug. The FDA had rejected the
drug in 2001 and 2003, asking for more safety information.
Ketek is most frequently prescribed for patients with chronic bronchitis; acute
bacterial sinusitis; and community acquired pneumonia of mild to
moderate severity, including pneumonia caused by resistant strep
infections.
When the FDA approved Ketek in April 2004, the drug's labeling
included precautions about liver injury and possible worsening of
myasthenia gravis, as with other drugs in its class.
Sanofi Adventis is now revising the drug labeling to address
the new concerns about Ketek’s potentially fatal impact.
Ketek's new label will also note that there have been reports of
fatal worsening of the neuromuscular condition, myasthenia gravis.
The FDA knows of three reported deaths in myasthenia gravis patients
taking Ketek. These deaths occurred separately from the reported
liver problems.
The drug is the
first FDA-approved antibiotic of the ketolide class, and the FDA has
concluded that the drugs’ benefit to patients for the approved
indications outweighs its risk. Following an internal FDA memo
reporting that Ketek has been linked to 12 cases of liver failure
and 4 deaths, French drug manufacturer Sanofi-Aventis confirmed on
May 19 that it was in discussion with the USDA about its antibiotic
Ketek after the USDA wanted a warning label put on the drug.
Recently, Ketek drug trials on children were widely criticized, even
from a few members of Congress. The drug had only been approved to
treat mild to moderate respiratory infections in adults.
The FDA
has said that it could not determine how frequently Ketek was
associated with adverse events, and concluded that since the drug’s
benefits outweighs its risks, it should stay on the
market.
Patients on Ketek should be vigilant, and watch for these signs and
symptoms of liver failure: fatigue, malaise, loss of appetite,
nausea, yellow skin and dark-colored urine.
KETEK LAWYERS /
ATTORNEYS
If you or a loved one have suffered from the
dangerous side effects of Ketek, you should
consider receiving a free legal evaluation from
an experienced injury lawyer. For a free
evaluation of your situation please complete the
following form and a Ketek
attorney will contact you promptly - free of
charge.
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