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U.S. Department of Health and Human Services

Drugs

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Telithromycin (marketed as Ketek) Information

On February 12, 2007, the FDA and the sponsor agreed on an updated label for Ketek (telithromycin), an antibiotic, and to distribute a Medication Guide (MedGuide) for patients.

The new label narrows the usage for Ketek by dropping two previously approved indications (acute bacterial exacerbation of chronic bronchitis due to Streptococcus pneumoniae, Haemophilus, influenzae, or Moraxella catarrhalis; and acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, or Staphylococcus aureus.)

Ketek is now indicated for the treatment of community‑acquired pneumonia (of mild to moderate severity) due to Streptococcus pneumoniae, (including multi-drug resistant isolates, Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae, for patients 18 years and older.

The updated label includes a boxed warning and a contraindication stating that no one with myasthenia gravis should take Ketek.  In addition, warnings were strengthened for hepatotoxicity (liver injury), loss of consciousness, and visual disturbances.

On June 29, 2006, the Food and Drug Administration notified healthcare professionals and patients that it completed its safety assessment of Ketek (telithromycin). FDA determined that additional warnings about the risk of liver toxicity are required and the manufacturer has revised the drug labeling to address this safety concern. In addition, the WARNINGS for patients with myasthenia gravis are being strengthened.

On January 20, 2006, the FDA advised the public that the Annals of Internal Medicine had published an article reporting three patients who experienced serious liver toxicity following administration of Ketek (telithromycin). These cases had also been reported to FDA MedWatch. Telithromycin is marketed and used extensively in many other countries, including countries in Europe and Japan.