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New warnings about Ketek (telithromycin)

January 25, 2006 - In the January 20, 2006, "Annals of Internal Medicine" an article was published reporting three patients who experienced serious liver toxicity following the administration of Ketek (telithromycin). These cases were also reported to FDA MedWatch. 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, the FDA is continuing to work to better understand the frequency of liver-related adverse events reported for approved antibiotics, including telithromycin.

While FDA is continuing its investigation of this issue, they 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 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.

In pre-marketing clinical studies, including a large safety trial and data from other countries, the occurrence of liver problems was infrequent and usually reversible. Based on the pre-marketing clinical data, it appeared that the risk of liver injury with telithromycin was similar to that of other marketed antibiotics. Nonetheless, the product label advises doctors about the potential for liver-related adverse events associated with the use of telithromycin.

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.

Questions or concerns regarding this important safety information can be directed to Sanofi-Aventis medical department at 1-800-981-2491. As always, pharmacies and members can also contact the RxAmerica customer service desk at 1-800-770-8014 if they have any questions about this new product warning.