Inpharma 1522 - 28 Jan 2006

US FDA to review telithromycinsafety and labelling

The US FDA has issued a Public Health Advisoryregarding Ketek [telithromycin] tablets stating that threecases of serious liver toxicity following Ketekadministration, including one death, have beenpublished in the Annals of Internal Medicine and thatthese cases have been reported to FDA Medwatch; theagency adds that the patients were treated in the samegeographical area, but that the significance of this is notclear. The FDA is continuing its evaluation oftelithromycin-associated liver problems to determinewhether labelling changes are required, and is workingto better understand the frequency of liver disordersassociated with antibacterials.

The FDA provides the following recommendations tohealthcare providers and patients:• Telithromycin recipients should be monitored by

healthcare providers for signs or symptoms of liverproblems, and the drug should be stopped in suchcases.

• Patients who are not experiencing adverse effects,such as jaundice, should continue takingtelithromycin as prescribed.

• Patients who experience any eye or skin yellowing,or other problems such as blurred vision, shouldcontact their healthcare provider immediately.

• Telithromycin should only be used to treat infectionscaused by a telithromycin-susceptible micro-organism.

The FDA says that, based on premarketing clinicaldata, the risk of telithromycin-associated liver injury wassimilar to that with other marketed antibacterials. Theagency notes that the current product label carriesadvice for doctors about possible liver-related adverseevents associated with telithromycin use.US Food and Drug Administration. Ketek (telithromycin) tablets. InternetDocument : [2 pages], 20 Jan 2006. Available from: URL: http://www.fda.gov 801013350

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Inpharma 28 Jan 2006 No. 15221173-8324/10/1522-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved