Sanofi-Aventis to place stronger warnings on Ketek

The European Medicines Agency (EMEA) has ordered Sanofi-Aventis to place stronger warnings on Ketek (telithromycin).

The agency has made the move after cases of serious acute hepatitis, including liver failure, occurred in some patients after using the antibiotic.

Ketek is used to treat bacterial infections involving the respiratory tract, such as pneumonia, sinusitis and bronchitis.

Product information about the Sanofi-Aventis product should now include stronger warnings concerning liver disorders.

EMEA said in a statement: “This is a precautionary measure, pending the outcome of a full benefit/risk assessment of the product in the context of the ongoing renewal procedure for the marketing authorisation.

“The reported serious liver reactions started during or immediately after treatment with Ketek and were, in most cases, reversible after use of this product was discontinued.”

In the US the Food and Drink Administration (FDA) is also investigating the drug.

Patients are being advised to stop treatment and contact their doctor if symptoms and signs of liver disease develop, such as loss of appetite, yellowing of skin and eyes, dark urine, itching or tender abdomen.

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