Editing Telithromycin (section)

===FDA Warning===
On February 12, 2007, after an advisory committee discussion and vote in December 2006, the FDA announced a revision to the labeling of Ketek. The changes included the removal of two of the three previously approved indications: acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. The agency determined that the balance of benefits and risks no longer supported approval of the drug for these indications. Ketek remained on the market for the treatment of community acquired bacterial pneumonia of mild to moderate severity (acquired outside of hospitals or long-term care facilities). In addition, the FDA worked with the manufacturer to update the product labeling with a "[[black box warning]]," their strongest form of warning. Ketek's warning states that it should not be used in patients with [[myasthenia gravis]], a disease that causes muscle weakness.<ref>{{cite web |url=https://www.fda.gov/bbs/topics/NEWS/2007/NEW01561.html |url-status=dead |archive-url=https://web.archive.org/web/20070214112915/http://www.fda.gov/bbs/topics/NEWS/2007/NEW01561.html |archive-date=2007-02-14 |title=FDA Announces Label and Indication Changes for the Antibiotic Ketek|website=[[Food and Drug Administration]] }}</ref> Following this decision, Sanofi-Aventis withdrew the drug from active sales in the United States.