The Pharmaceutical Journal
Vol 276 No 7386 p124
4 February 2006

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European Medicines Agency reviews cases of liver injury associated with telithromycin

A preliminary review of cases of serious liver injury associated with telithromycin (Ketek) has led the European Medicines Agency to ask for warnings concerning liver disorders to be strengthened in product information.

Serious acute hepatitis, including liver failure, starting during or immediately after treatment with telithromycin, has been reported to, and assessed by, the EMEA. In most cases the reactions were reversible but some were fatal. Three particular cases of serious liver injury, one fatal, were recently described in an article published online on 20 January in Annals of Internal Medicine.

The EMEA will now conduct a full risk/benefit assessment of the product to determine whether further actions are warranted. In the meantime, it reminds prescribers that telithromycin should be used with caution in patients with liver impairment, and that patients should stop treatment and contact their doctors if signs and symptoms of liver disease develop.