Reactions 1109 - 8 Jul 2006

Ketek’s labelling to include newsafety information, says US FDAThe US FDA has announced that it has completed its

safety assessment of Ketek [telithromycin], thatadditional warnings are needed, and that it is advisingpatients and health practitioners to be aware of rare butpotentially serious health risks associated with the drug.

According to the FDA, Ketek’s labelling is to berevised by its manufacturer, Sanofi Aventis, to highlightthat the drug has been associated with rare cases ofserious liver injury and liver failure, including one livertransplant and four reported deaths. The agency statesthat it concluded that the drugs’ benefits outweighs itsrisks and supports its continued availability. Ketek-associated safety issues will continued to be evaluatedby the agency and further actions will be taken ifwarranted, says the FDA.

Dr. Steven Galson, Director for FDA’s Center for DrugEvaluation and Research, says that patients experiencingsigns or symptoms of liver problems should discontinueKetek and seek medical assessment.

See also Reactions 1106 p4; 801013540 andReactions 1087 p3; 809059426FDA. FDA Completes Safety Assessment of Ketek New Safety Information to beAdded to Product Labeling. Media Release : 29 Jun 2006. Available from: URL:http://www.fda.gov 809065288

» Editorial comment: Earlier this year, the US FDA issued aPublic Health Advisory stating that three cases of Ketek[telithromycin]-associated serious liver toxicity have beenreported [see Reactions 1086 p2; see Reactions 1086 p2;801013350].

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Reactions 8 Jul 2006 No. 11090114-9954/10/1109-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved