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FDA REVISIONS: Ketek meds for sinusitis/bronchitis

FDA REVISIONS: Ketek meds for sinusitis/bronchitis

Thought it worthwhile to post here, regarding the subject.

New Limits to Ketek Use, FDA Says

February 13, 2007
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In addition, a patient medication guide has been developed to inform patients regarding the risks and safe use of telithromycin. The information sheet will be dispensed with each prescription.

According to an FDA news release, the revisions were based on comprehensive scientific analysis and thoughtful public discussion of available data and are consistent with December 2006 recommendations from a joint panel of the FDA's Anti-Infective Drugs and Drug Safety and Risk Management Advisory committees.

Telithromycin remains approved only for the treatment of mild to moderate cases of community-acquired pneumonia.

http://www.medscape.com/viewarticle/552110?sssdmh=dm1.247662&src=ddd

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