FDA & Prescription Drugs

Revised Black Box Warning For KETEK (Telithromycin)

KETEK (telithromycin), manufactured and sold by Sanofi-aventis U.S. recently decided, after prompting by the U.S. Food and Drug Administration, to include a revised black box warning and contraindication for myasthenia gravis patients. The new warning also removed the labels recommendation that KETE

M. Brandon Smith

M. Brandon Smith

Revised Black Box Warning For KETEK (Telithromycin)

KETEK (telithromycin), manufactured and sold by Sanofi-aventis U.S. recently decided, after prompting by the U.S. Food and Drug Administration, to include a revised black box warning and contraindication for myasthenia gravis patients. The new warning also removed the labels recommendation that KETEK be used in patients with chronic bronchitis (AECB) and acute bacterial sinusitis (ABS).

For more information on the revised KETEK black box warning see the “Dear HealthCare Professional Letter“:

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