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FDA Public Health Advisory
Ketek (telithromycin) Tablets
Today, January 20, 2006, Annals of Internal Medicine
published an article reporting three patients who experienced
serious liver toxicity following administration of Ketek (telithromycin).
These cases have also been reported to FDA MedWatch. Telithromycin
is marketed and used extensively in many other countries, including
countries in 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
telithromycin 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 telithromycin.
While FDA is continuing its investigation of this issue, we are
providing the following recommendations to healthcare providers and
patients:
- Healthcare providers should monitor patients taking
telithromycin for signs or symptoms of liver problems. Telithromycin should be
stopped in patients who develop signs or symptoms of liver problems.
- Patients who have been prescribed telithromycin and are not
experiencing side effects such as jaundice should continue taking
their medicine as prescribed unless otherwise directed by their
healthcare provider.
- Patients who notice any yellowing of their eyes or skin or
other problems like blurry vision should contact their healthcare
provider immediately.
- As with all antibiotics, telithromycin should only be used for
infections caused by a susceptible microorganism. Telithromycin is
not effective in treating viral infections, so a patient with a
viral infection should not receive telithromycin since they would
be exposed to the risk of side effects without any benefit.
The case review in today’s online publication by Annals of
Internal Medicine reports three serious adverse events following
administration of telithromycin. All three patients developed
jaundice and abnormal liver function. One patient recovered, one
required a transplant, and one died. When the livers of the latter
two patients were examined in the laboratory, they showed massive
tissue death. These two patients had reported some alcohol use. All
three patients had previously been healthy and were not using other
prescription drugs. The FDA is also aware that these patients were
all treated by physicians in the same geographic area. The
significance of this observation is not clear at the present time.
At the time of approval, the Ketek (telithromycin) product label included a precautionary statement advising doctors that hepatic adverse events (hepatic dysfunction, increased liver enzymes and hepatitis, with or without jaundice) had been reported with Ketek and that these events were generally reversible. This precaution was based upon the findings from the phase three clinical studies and postmarketing data from other countries.
Telithromycin is an antibiotic of the ketolide class. It was the
first antibiotic of this class to be approved by the FDA in April,
2004 for the treatment of respiratory infections in adults caused by
several types of susceptible microorganisms including
Streptococcus pneumoniae and Haemophilus influenzae.
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Date created: January 20, 2006, corrected February 16, 2007 |
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