Sanofi Aventis in talks with FDA over Ketek dangers

Sanofi-Aventis has announced it is in talks with the FDA following the release of an FDA memo which revealed it was considering that Ketek, an antibiotic, should be given the restrictive ‘black box’ label.

On Friday the Wall Street Journal reported the details of an FDA report which suggested a link between the use of Ketek and 12 cases of liver failure, resulting in four deaths. Ketek, known as telithromycin, was approved by the EU in 2001 and then by the FDA in 2004. According to the memo, the side-effects demonstrated by Ketek were increased in comparison to other antibiotics of a similar nature.

The FDA told Reuters that the memo would not be publicly available but it confirmed that more information was being considered for the Ketek label, including the possibility of giving the drug the ‘black box’, which would impose certain warnings on the label.

According to Reuters, Sanofi-Aventis said that it still believed that Ketek was “safe and effective”.

A spokesman said: “We are in talks with the FDA to evaluate secondary effects on the liver and as we are in discussions we are not going to start commenting on these figures.”

Ketek is the only ketolide antibiotic currently marketed and it is based on erythromycin. It is designed for use in mild to moderate respiratory tract infections, such as acute exacerbation of chronic bronchitis (AECB) and community-acquired pneumonia, according to Sanofi-Aventis. During clinical trials it displayed “unsurpassed” therapy in (AECB) cases in comparison to some other comparable antibiotics already on the market.

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