(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, 12 adults taking Ketek have suffered
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
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
antibiotic resistance has rendered many older antibiotics
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
accommodated a drug maker and turned a blind eye to serious
safety concerns," Grassley said.