Antibiotic Rule - a Small Step and a Sad Indictment
ANALYSIS - The US Food and Drug
Administration's decision to ban 'extra-label' or
unapproved uses for certain antibiotics is small step in the direction towards reducing
the potential risk of antibiotic resistance in humans.
Administration's decision to ban 'extra-label' or
unapproved uses for certain antibiotics is small step in the direction towards reducing
the potential risk of antibiotic resistance in humans.
The order from the FDA, which comes into effect
from 5 April this year prohibits certain uses
of the cephalosporin class of antimicrobial drugs in
cattle, swine, chickens and turkeys.
The FDA says it is taking this action to preserve the
effectiveness of cephalosporin drugs fo
r treating disease in humans and prohibiting these
uses is intended to reduce the risk of
cephalosporin resistance in certain bacterial
pathogens.
The FDA stresses that antimicrobial drugs are
important for treating disease in both humans
and animals. This new order takes into consideration
the substantial public comment FDA
received on a similar order that it issued in 2008,
but revoked prior to implementation
However, the new order that is now in a consultation
period until 6 March only bans
cephalosporin drugs at unapproved dose levels
, frequencies, durations, or routes of
administration and it prohibits using cephalosporin
drugs in cattle, swine, chickens or turkeys
that are not approved for use in that species (e.g.,
cephalosporin drugs intended for humans
or companion animals) and also bars the use of
cephalosporin drugs for disease prevention.
The order does not limit the use of cephapirin, an
older cephalosporin drug that is not believed by FDA
to contribute significantly to antimicrobial
resistance.
Veterinarians will still be able to use or prescribe
cephalosporins for limited "extra-label" use in cattle,
swine, chickens or turkeys, provided they follow the
dose, frequency, duration, and route of
administration that is on the label.
Veterinarians may also use or prescribe
cephalosporins for "extra-label" uses in minor
species of food-producing animals such as ducks or
rabbits.
Even Congresswoman, Louise Slaughter, who is
leading a campaign to prohibit the use of drugs that
could cause antibiotic resistance in humans,
described the FDA move at "a modest first step"
"We're really just looking at the tip of the iceberg,"
she said.
"We don't have time for the FDA to ploddingly take
half-measures. We are staring at a massive public
health threat in the rise of antibiotic-resistant
superbugs. We need to start acting with the
swiftness and decisiveness this problem deserves."
In effect, the FDA is only telling vets what they
should already be practising - not to misuse the
drugs and only use them for what they are intended.
And perhaps the fact that the FDA has felt in
necessary to take this step is more of an indictment
on the way that these drugs have been used
indiscriminately in the past
from 5 April this year prohibits certain uses
of the cephalosporin class of antimicrobial drugs in
cattle, swine, chickens and turkeys.
The FDA says it is taking this action to preserve the
effectiveness of cephalosporin drugs fo
r treating disease in humans and prohibiting these
uses is intended to reduce the risk of
cephalosporin resistance in certain bacterial
pathogens.
The FDA stresses that antimicrobial drugs are
important for treating disease in both humans
and animals. This new order takes into consideration
the substantial public comment FDA
received on a similar order that it issued in 2008,
but revoked prior to implementation
However, the new order that is now in a consultation
period until 6 March only bans
cephalosporin drugs at unapproved dose levels
, frequencies, durations, or routes of
administration and it prohibits using cephalosporin
drugs in cattle, swine, chickens or turkeys
that are not approved for use in that species (e.g.,
cephalosporin drugs intended for humans
or companion animals) and also bars the use of
cephalosporin drugs for disease prevention.
The order does not limit the use of cephapirin, an
older cephalosporin drug that is not believed by FDA
to contribute significantly to antimicrobial
resistance.
Veterinarians will still be able to use or prescribe
cephalosporins for limited "extra-label" use in cattle,
swine, chickens or turkeys, provided they follow the
dose, frequency, duration, and route of
administration that is on the label.
Veterinarians may also use or prescribe
cephalosporins for "extra-label" uses in minor
species of food-producing animals such as ducks or
rabbits.
Even Congresswoman, Louise Slaughter, who is
leading a campaign to prohibit the use of drugs that
could cause antibiotic resistance in humans,
described the FDA move at "a modest first step"
"We're really just looking at the tip of the iceberg,"
she said.
"We don't have time for the FDA to ploddingly take
half-measures. We are staring at a massive public
health threat in the rise of antibiotic-resistant
superbugs. We need to start acting with the
swiftness and decisiveness this problem deserves."
In effect, the FDA is only telling vets what they
should already be practising - not to misuse the
drugs and only use them for what they are intended.
And perhaps the fact that the FDA has felt in
necessary to take this step is more of an indictment
on the way that these drugs have been used
indiscriminately in the past
