Telithromycin is an FDA approved antibiotic drug, which belongs to the ketolide class, marketed in the U.S. by Sanofi Aventis under the brand name Ketek. Telithromycin was U.S. approved in April 2004.Telithromycin is indicated for the treatment of bacterial infections such as community-acquired pneumonia, acute bacterial sinusitis, and acute bacterial exacerbation of chronic bronchitis.
A report in the Annals of Internal Medicine explains that three patients had jaundice and abnormal liver function after taking telithromycin (Ketek). One patient recovered, one required a transplant, and one died. All three patients had previously been healthy.
At the time of market approval for telithromycin (ketek), the product label included a precautionary statement advising doctors that hepatic adverse event (hepatic dysfunction, increased liver enzymes and hepatitis, with or without jaundice) had been reported and that these events were generally reversible. This precaution was based upon the findings from the phase three clinical studies and post-marketing data from other countries.
Patients who have been prescribed telithromycin and who notice any yellowing of their eyes or skin or other problems like blurry vision should contact their healthcare providers. 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.
Telithromycin is marketed and used extensively in many other countries, including Japan and European countries. 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.
If you or a loved one is the victim of telithromycin liver damage, please contact us about a possible lawsuit. Find out what your legal options are.
