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FDA to Withdraw Approval of Two Poultry Antibiotics
November 2000
The US Food and Drug Administration Center for Veterinary Medicine
(CVM)
is withdrawing its approval of two fluoroquinolones for use in poultry.
According an FDA statement, consumption of poultry that contains
fluoroquinolone-resistant Campylobacter is the main cause of
fluoroquinolone-resistant Campylobacter infection in humans.The drugs
are enrofloxacin, manufactured by the Bayer Corp., of Shawnee Mission,
Kansas, and sarafloxacin hydrochloride, manufactured by Abbott
Laboratories, of North Chicago, Illinois.
The two fluoroquinolones have been widely used since the mid-1990s in chickens and turkeys to reduce
mortality from Escherichia coli and Pasteurella multocida. Between 1996
and 1997, resistance to fluoroquinolones among Campylobacter organisms
increased, coinciding with the approval of these drugs for use in
poultry, according the FDA.Using data from the National Antimicrobial
Resistance Monitoring System (NARMS) and other sources, the FDA has
determined that fluoroquinolones in poultry cause Campylobacter
resistance, which is a significant cause of fluoroquinolone-resistant
Campylobacter infection in humans."These are drugs that have been
previously approved," a spokesperson from the FDA told Reuters Health.
"What we are asking is that the drugs be withdrawn--we want the
manufacturers to pull these drugs from the market."
John B. Payne,
senior vice president of Animal Health at Bayer claims the FDA position is
"contradictory to the government's own NARMS data for the same period."
Payne told Reuters Health, "we think that the NARMS data show that the
incidence of resistance is going down in animals, not going up."Payne
explained that "this isn't a huge product in terms of sales for us,
because it is an expensive antibiotic and it has specific label claims.
Since it is used judicially, it is only used to treat about 1.5% of the
broilers in the US," he said. "But it is the only effective treatment
option for certain serious respiratory tract infections in poultry."
According to Payne, they have not seen the FDA data yet. "We asked for
the data ahead of time and offered to be cooperative with CVM, but they
weren't willing to share it with us. Up to this point, we are not aware
of why they are taking this action," he added. Bayer plans to review
the
data and respond to the FDA within 60 days.
Commenting on Bayer's
statement, an FDA spokesperson said, "If a company is interested in
presenting data, we will evaluate it to see if it might resolve our
concerns, and then we will make a final determination." A spokeswoman
for Abbott Laboratories told Reuters Health, that they have chosen to
cooperate with the FDA request. Furthermore, she said, "the withdrawal
of fluoroquinolones will not have any impact on any other Abbott
products or on our sales or earnings."
The FDA decision is supported by
the Infectious Diseases Society of America, according to a Society
statement. The IDSA also supports the Agency's continuing evaluation of
antibiotics in animals to ensure the continued effectiveness of these
agents in humans.
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