Jan Drew
July 6th 06, 04:45 PM
http://www.newstarget.com/z019516.html
NewsTarget.com printable article
Originally published June 30 2006
FDA admits children's antibiotic could cause liver failure, but allows its
sale anyway
(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.
NewsTarget.com printable article
Originally published June 30 2006
FDA admits children's antibiotic could cause liver failure, but allows its
sale anyway
(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.