Sanofi-Aventis faces antibiotic investigation

The US Food and Drink Administration (FDA) is to investigate claims that Sanofi-Aventis’ antibiotic Ketek (telithromycin) causes liver damage.

The FDA has urged doctors to watch patients taking the antibiotic after the journal Annals of Internal Medicine reported liver damage in three cases. One patient died, one needed a transplant and the third recovered.

The new type of antibiotic, known as a ketolide, is used for airway infections, such as acute sinusitis, tonsillitis and chronic bronchitis, and works by stopping bacteria produce the proteins they need to reproduce.

Ketek was the first ketolide to be given approval by the FDA in 2004.

The administration said: “In pre-marketing clinical studies, including a large safety trial and data from other countries, the occurrence of liver problems was infrequent and usually reversible.

“Based on the pre-marketing clinical data, it appeared that the risk of liver injury with telithromycin was similar to that of other marketed antibiotics. Nonetheless, the product label advises doctors about the potential for liver-related adverse events associated with the use of telithromycin.”

A Sanofi-Aventis spokesman told Reuters: “With what we know now, we’ve concluded that these events do not alter the drug’s safety profile.”

He added the company would work with health authorities and implement any safety measures suggested.

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