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Tuesday, January 10, 2012

Antibiotic Rule - a Small Step and a Sad Indictmen


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.


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

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