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 Reports State That Bronchitis Drug Ketek May Cause Liver Failure, Death
Ketek News
Updates
On
June 29, 2006, the U.S. Food and Drug Administration ordered the makers
of Ketek to put a stronger warning on the drug labels because of its
link to serious side effects including 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 Antibiotic Liver Damage News &
Lawyer Updates
Approval of Antibiotic, Ketek, Worried Safety Officials
The New York Times - July 19, 2006
A federal official concluded that Ketek, a
controversial antibiotic made by a French drug company, should be
withdrawn, e-mail messages show.
Hepatoxicity Warning Added to Ketek Label
MedPage Today - June 30, 2006
The FDA has approved a label revision for the antibiotic
Ketek (telithromycin) warning of possible severe and sometimes fatal
liver injury during or immediately following treatment with the drug.
Sanofi-Aventis adds warning to antibiotic Ketek after FDA discussions
Forbes -
June 29, 2006
...French pharmaceutical company Sanofi-Aventis
said it has revised the prescribing information for its antibiotic Ketek
following discussions with the US Food and Drug Administration.
A dozen liver damage reports cited in Ketek patients
Reuters UK - June 29, 2006
... Four of the patients died and one needed a liver transplant, said
Dr. Gerald Dal Pan of the FDA's Office of Epidemiology and
Surveillance..
For
Ketek Antibiotic Liver Damage Lawyer Representation contact us
in:
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