drugs information

Ketek Black Box Warning

Market Name: Ketek

Generic Name: Telithromycin

Ketek, manufactured by Sanofi Aventis pharmaceuticals, is a treatment for community-acquired pneumonia in adults over the age of 18.

In February 2007, a black box warning advising of the possibility of serious liver damage, vision problems and fainting associated with the use of Ketek was added to the drug’s prescribing information. In addition, those patients suffering from Myasthenia Gravis (a rare disease causing muscle weakness) were warned that Ketek could cause a worsening of their symptoms, including life-threatening respiratory problems.

Black Box Warning Date: February 2007

FDA Link: Ketek

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