Ketek May Well Lose Sinusitis And Bronchitis Approval, FDA

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Main Category: Respiratory / Asthma
Also Included In: Ear, Nose and Throat;  Infectious Diseases / Bacteria / Viruses
Article Date: 16 Dec 2006 - 10:00 PDT

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Ketek (telithromycin), an antibiotic used to combat pneumonia, as well as treating bronchitis and sinusitis, got an unfavorable review from an FDA Advisory Committee (panel) yesterday. Ketek's pneumonia indication may soon come with a 'black box' warning, while its approval for the treatment of sinusitis and bronchitis will go altogether if the FDA does what the panel recommends. The FDA generally does what the panel advises.

17 members of the panel voted that Ketek's benefits for bronchitis and sunusitis patients are not greater than the risks, 2 members voted the other way. For community-acquired pneumonia, the panel voted 16 to 3 that Ketek's benefits outweigh the risks. The panel voted 13 to 5 that Ketek should have a 'black box' warning for pneumonia indication.

Dr. John Jenkins, Center for Drug Evaluation and Research, FDA, said "For community-acquired pneumonia, we got a general sense from the committee that the majority of members felt there should be a black-box warning added to the labeling to address some of the risks associated with the drug. We also got the sense - and the company is in agreement - that there should be a medication guide required to be handed out with each prescription."

Dr. Jenkins did not say outright that the sinusitis and bronchitis indication approvals will be dropped, he stressed that the FDA will be assessing the advice it heard from the panel and will be discussing that internally.

Ketek was approved for bronchitis, sinusitis and pneumonia in 2004. Since its approval there have been scores of reports of patients experiencing liver damage, and some other undesirable side-effects, such as blurred vision. Last year sales of Ketek reached $193 million for Sanofi-Aventis. Sales this year in the USA alone have hit $71 million so far. Ketek is approved in over 90 countries, 28 million people worldwide have taken it.

The EMEA (European Medicines Agency) panel said "Ketek must not be used in patients with previous history of hepatitis and/or jaundice associated with the use of telithromycin.". Click here to view EMEA document (PDF)

Written by: Christian Nordqvist
Editor: Medical News Today


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