What actions were taken by FDA on February 12, 2007?
The FDA approved new labeling with a Medication Guide for patients. The new labeling removes the indications of acute bacterial sinusitis and acute exacerbation of chronic bronchitis; adds a boxed warning and contraindication that states that Ketek is contraindicated (should not be used) in patients with myasthenia gravis; strengthens warnings about visual adverse effects and loss of consciousness; and provides a Medication Guide so that patients can be better informed about the risks associated with use of telithromycin. These changes are in addition to the bolded warning on liver toxicity added to the label in June 2006.
