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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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Additional Information

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