RE: FDA Approves First Injectable Solution for Chemical Steriliza tion in Dogs.htm

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Stone, Jacqueline

Tuesday, May 20, 2003 9:34 AM

Stone, Jacqueline

FDA Approves First Injectable Solution for Chemical Sterilization

in Dogs.htm

 

 

 

 

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FDA Talk Paper

 

 

T03-35

May 19, 2003

 

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FDA Approves First Injectable Solution for Chemical Sterilization in Dogs

 

 

The Food and Drug Administration (FDA) has approved the first product for

chemical sterilization of male puppies. The drug, Neutersol Injectable

Solution, provides an alternative to surgical castration, and may prove to

be a valuable aid in efforts to control burgeoning dog populations.

 

Neutersol is administered by direct injection into the testicles. Unlike the

surgical procedure, Neutersol does not require the use of general

anesthesia, though sedation is recommended to prevent the dog from moving

during injection.

 

While surgical castration significantly reduces testosterone production, the

use of Neutersol may not. Also, it may not eliminate unwanted male behaviors

such as roaming, marking, or aggression. In addition, this product may not

protect against diseases associated with male hormones in dogs, such as

prostatic disease or testicular and perianal tumors.

 

Pet overpopulation is a serious public health problem. Uncontrolled breeding

of pets affects not only the animals and shelters but forces communities to

spend millions of dollars to feed, shelter, and protect lost or unwanted

animals. Pet shelters with on-site veterinarians can sterilize male puppies

before they leave the shelter, rather than relying on the person adopting

the dog to take it to the veterinarian for surgical sterilization.

 

Proper injection technique and post-injection care are critical for the safe

use of the product. In tests, researchers discovered that the greatest

potential risk was ulcers of the scrotum at the injection site, caused by

incorrect injection or movement of the needle during injection. To help

educate veterinarians and dog owners about safety issues and to prevent the

occurrence of serious adverse events, the approved labeling includes an

instructional videotape demonstrating the proper injection technique, and a

client information sheet explaining the importance of post-injection care.

 

Addison Biological Laboratory, Inc., Columbia, Mo., is the manufacturer of

Neutersol Injectable Solution, which will be available for use only by or on

the order of a licensed veterinarian.

 

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