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GENERAL INFORMATION |
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| FDA
Completes Safety Assessment of Ketek New Safety
Information to be Added to Product Labeling |
| The Food
and Drug Administration (FDA) today completed its
safety assessment of Ketek (telithromycin) and
is advising health practitioners and patients to
be aware of rare but potentially serious health
risks. Ketek is the first FDA-approved antibiotic
of the ketolide class. It is indicated for the
treatment of acute exacerbation of chronic bronchitis;
acute bacterial sinusitis; and community acquired
pneumonia of mild to moderate severity, including
pneumonia caused by resistant strep infections.
The drug has been associated with rare cases of
serious liver injury and liver failure with four
reported deaths and one liver transplant after
the administration of the drug. The manufacturer
is revising the drug labeling to address this safety
concern. |
| Although
it is difficult to determine the exact frequency
of Ketek-associated adverse events on the basis
of FDA’s mandatory and voluntary reporting
systems, the agency has concluded that the
drugs’ benefit to patients for the approved
indications outweighs its risk, including the
rare risk of liver failure, and supports its
continued availability. |
| “We are advising
both patients taking Ketek and their doctors
to be on the alert for signs and symptoms of
liver problems," said Dr. Steven Galson,
Director for FDA’s Center for Drug Evaluation
and Research. "Patients experiencing such
signs or symptoms should discontinue Ketek
and seek medical evaluation, which may include
tests for liver function." The signs and
symptoms of liver failure include fatigue,
malaise, loss of appetite, nausea, yellow skin
and dark-colored urine. |
| The warning, which
Ketek’s manufacturer is adding to the
drug’s labeling, results from FDA’s
vigilant monitoring of all drugs after their
introduction to the market. When the agency
approved the drug in 2004, based on data in
the marketing application, the risk of liver
injury with Ketek was similar to that of other
marketed antibiotics. |
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Cabraser Heimann & Bernstein,
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| A safety evaluation conducted
one year after approval was consistent with this.
However, as the product entered into wider use,
FDA’s adverse event monitoring system received
some reports of serious liver problems in patients
taking Ketek, including some cases of acute liver
failure leading to death or requiring liver transplantation. |
| Following receipt
of these reports, FDA conducted a rigorous
and thorough assessment of existing data, and
continued to engage in U.S. and ex-U.S. monitoring
of additional post market events. This work
involved efforts by experts in the agency’s
Office of Surveillance and Epidemiology and
the Office of New Drugs, as well as by recognized
external liver disease experts. FDA tracked
reports of adverse events associated with Ketek
via MedWatch and also had the benefit of three
case reports described in the February ’06
issue of Annals of Internal Medicine. FDA has
now completed its evaluation of this information
and determined that additional warnings are
required. |
| FDA will continue
to evaluate Ketek-associated safety issues
and take further actions if warranted. It is
important to note that negative effects on
liver function are a known and potential complication
with some antibiotics, including Ketek, and
as drug usage becomes more widespread, it is
expected that rare adverse events may be detected
or reported in greater numbers. |
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