Sanofi Aventis changes Ketek label after safety concerns

Sanofi-Aventis has altered its American label for the antibiotic Ketek following an FDA assessment of the safety of the drug.

It found that clinicians and patients should be made aware of “rare but potentially serious” health risks. The US drugs regulator found that Ketek was associated with some cases of acute liver failure, reportedly resulting in four deaths and one liver transplant.

However, the FDA concluded that the drug’s benefit outweighs the “rare risk” of liver failure.

Dr Stephen Galson, director of the FDA’s centre for drug evaluation and research, said: “We are advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems.”

“Patients experiencing such signs or symptoms should discontinue Ketek and seek medical evaluation, which may include tests for liver function,” he added.

Sanofi-Aventis said it had conducted a “rigorous” study of Ketek data and had formed the “most informed understanding possible” about the drug’s potential side effects.

Sol Rajfer, president of US science and medical affairs at Sanofi-Aventis US, said: “Based on the in-depth review of the clinical trial and postmarketing data, we continue to believe that the benefits of Ketek outweigh the risks when the drug is used as directed for its approved indications.”

Earlier this month, Sanofi-Aventis paused paediatric clinical trials for Ketek to ensure the study matched with the FDA’s consensus over paediatric trials, not because of any safety concerns.

Ketek is the first in a new class of antibiotics. It has been approved for the treatment of acute bacterial exacerbation of chronic bronchitis, acute bacterial sinusitis and mild to moderate community-acquired pneumonia.

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