|
Questions and
Answers on Telithromycin (marketed as Ketek)
1. What is telithromycin?
Telithromycin is an FDA approved antibiotic drug, which belongs
to the ketolide class, marketed in the U.S. by Aventis under the
brand name Ketek. Telithromycin was approved in the U.S. in April
2004.
2. What is telithromycin used to treat?
Ketek (telithromycin) is indicated for the treatment for the following types of bacterial infections: community-acquired pneumonia (including multi-drug-resistant Streptococcus pneumoniae), acute bacterial sinusitis, and acute bacterial exacerbation of chronic bronchitis
3. Why are the three reports described in the Annals of
Internal Medicine significant?
These reports are significant due to the serious nature of the
adverse events. All three patients had jaundice and abnormal liver
function. One patient recovered, one required a transplant, and one
died. All three patients had previously been healthy.
4. Did FDA know about these reports prior to this
publication?
Yes.
The FDA’s MedWatch program received reports of the three serious
adverse events following administration of telithromycin that were
published in the Annals of Internal Medicine.
FDA has also received other reports of liver-related adverse events in patients taking telithromycin. Some of these reports were difficult to interpret because they involved patients already taking other medicines or patients with other medical conditions that might cause liver problems.
5. What actions did FDA take regarding these reports?
The Office of Drug Safety looked at adverse events, including
hepatic adverse events, in a consult in June 2005 and concluded that
there was no new information that changes its assessment of the
hepatic risks.
6. What information was known about liver problems related to telithromycin at the time of approval?
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.
7. What should patients do regarding this new
information?
Patients who have been prescribed telithromycin and are not
suffering side effects such as jaundice should continue taking their
medicine as prescribed.
Patients who notice any yellowing of their eyes or skin or other
problems like blurry vision should contact their healthcare
providers.
8. What should healthcare providers do in response to
this new information?
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.
As with all antibiotics, telithromycin should only be used for
infections by a susceptible microorganism; telithromycin is not
effective on viral infections, so a patient with a viral infection
who took telithromycin would be taking a risk without any benefit.
9. What additional actions are likely to follow?
Telithromycin is marketed and used extensively in many other
countries, including Japan and countries in Europe. The FDA is
working with regulatory authorities in these other countries to
obtain further information on reports of liver problems associated
with the use of telithromycin. While it is difficult to determine
the actual frequency of adverse events from voluntary reporting
systems such as the MedWatch program, FDA is continuing to work to
understand better the frequency of liver-related adverse events
reported for approved antibiotics, including telithromycin.
 Back
to Top 
Back to Telithromycin
Date created: January 20, 2006, updated May 18, 2006, corrected April 10, 2007 |
