FDA admits children's antibiotic could cause liver failure, but allows its sale

July 1, 2006

FDA admits children's antibiotic could cause liver failure, but allows

its sale anyway

Friday, June 30, 2006 by NewsTarget, Key concepts: antibiotic,

antibiotics and liver failure.

(NewsTarget) -- Though the Sanofi-Aventis antibiotic Ketek has been

shown to damage the liver and sometimes cause death after a few doses,

the FDA says the drug's benefits outweigh its risks and has allowed

the product to remain on the market.

Ketek is often prescribed to children. It has been approved to treat

sinusitis, bronchitis and mild-to-moderate pneumonia. According to the

New York Times, an FDA safety reviewer argued in May that

Sanofi-Aventis should stop testing Ketek on children with ear

infections. He said that reducing the length of ear pain by one day

was not worth risking death. The drug firm has since " paused " its

pediatric trials, but according to Dr. John Jenkins of the FDA's

Office of New Drugs, discussions are under way to determine if testing

can resume.

In the United States, 14 adults taking Ketek have suffered liver

failure -- four of whom have died -- and 23 others have suffered

serious liver injury. In a review of the drug, safety officials

determined that while other antibiotics have been shown to damage the

liver, Ketek appears to do so four times as often.

Dr. Jenkins argues that Ketek should be kept on the market despite its

risks because new antibiotics are badly needed. He says antibiotic

resistance has rendered many older antibiotics ineffective.

However, Senate Finance Committee chairman Charles E. Grassley,

R-Iowa, along with Rep. Edward J. Markey, D-Mass., and Rep. Henry A.

Waxman, D-Calif., have launched an investigation into the FDA's

actions concerning Ketek.

" Ketek is another example where the FDA accommodated a drug maker and

turned a blind eye to serious safety concerns, " Grassley said.

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