Ketek
Reports State That Bronchitis Drug Ketek May Cause Liver
Failure, Death
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 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.
The Law Offices of William F. Horsley, P.A. has experience helping victims of pharmacy malpractice in the state of North Carolina. Please contact us if you have any questions about an injury you have suffered, or to report a pharmacy malpracitce case that you have. You may call us at 1-800-953-2542 or contact us through our
online form.
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