Ketek gets new warnings, limit on use

The U.S. Food and Drug Administration (FDA) today announced revisions to the labeling for Sanofi-Aventis controversial antibiotic Ketek (telithromycin).

The controversy of telithromycin (generic name of Ketek) sparked in early July 2006, when hundreds of cases of liver damage, loss of consciousness and other side effects had been reported and the FDA safety officials rated the drug's approval as an error.

Previously prescribed for acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis, now the drug will only remain on the market for the treatment of community acquired pneumonia of mild to moderate severity for patients above 18 years of age, FDA said.

The drug will carry a “black box” warning - the strongest possible. The warning states that Ketek should not be used in patients with myasthenia gravis, a disease that causes muscle weakness.

Other labeling changes include a strengthened warning section regarding specific drug-related adverse effects including visual disturbances and loss of consciousness and hepatotoxicity.

The drug will also come along with a Patient Medication Guide, developed by the FDA and Sanofi-Aventis, informing people about the risk and safe usage of the antibiotic.

The Medication Guide (an FDA-approved patient information sheet) will be provided to patients with each prescription, FDA said.

Marketed under the brand name of Ketek, telithromycin is the first ketolide antibiotic to enter clinical use. It is used to treat mild to moderate respiratory infections.

Originally approved in 2004 and manufactured by Sanofi Aventis, the common side-effects of the drug included diarrhoea, nausea, abdominal pain and vomiting. Headache and disturbances in taste also occur in some cases. Less common side-effects include palpitations, blurred vision and rashes. But rare and severe side effects of the drug were reported in January 2006 involving liver damage.

One of the 3 largest pharmaceutical companies in the world, along with Pfizer and GlaxoSmithKline, Sanofi-aventis, formed in 2004 is headquartered in Paris, France.

Sanofi-Aventis engages in the research, development, manufacturing and marketing of pharmaceutical products chiefly in the prescription market, but the company also develops certain over-the-counter medications.