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dwerten · 10-04-2009, 05:23 AM

When giving a pet an NSAID, watch for these side effects, which are listed on the Client Information Sheet and on the drug label:
• Decrease or increase in appetite
• Vomiting
• Change in bowel movements (such as diarrhea or black, tarry, or bloody stools)
• Change in behavior (such as decreased or increased activity level, seizure, aggression, or lack of coordination)
• Yellowing of gums, skin, or whites of the eyes (jaundice)
• Change in drinking habits (frequency or amount consumed)
• Change in urination habits (frequency, color, or smell)
• Change in skin (redness, scabs, or scratching).
These side effects are the most common. But not all possible side effects are included on the Client Information Sheet or on the drug label. Always contact your veterinarian if you have questions about your dog's medication.
What starts out as a minor problem can rapidly progress to an emergency. An owner should be encouraged to call his or her veterinarian with any concerns about the NSAID the dog is receiving. You may even call the drug manufacturer's toll-free number that appears on each Client Information Sheet. When problems are experienced with a product, the manufacturer may have specific recommendations for your veterinarian regarding tests and treatments.
Cindi Brinkley of Danville, Ill., rushed her dog to the veterinarian at the first sign of a bad reaction. Maude, a cocker spaniel-collie mix, injured herself when she was 11 months old while playing with a littermate in the house. "She slipped on the basement floor coming out of a turn, and both back legs splayed out," says Brinkley.
Maude was diagnosed with a deformed hip joint and scheduled for corrective surgery. In the meantime, the veterinarian prescribed an NSAID for pain control. "I was not told a thing about the drug other than how to give it to her," says Brinkley.
Maude had been on the drug for a month when Brinkley came home from work one day to find the dog bleeding from her rectum. "It was very, very frightening," she says. "The whole back of my dog was bright red--I thought she was bleeding to death." After treatment in the veterinary hospital and discontinuation of the drug, Maude recovered from the incident. Now more than 7 years old, "she has some vomiting and loose stools every so often," says Brinkley, who suspects the digestive problems may be a lasting effect of the drug.
Report Bad Reactions
If you or your veterinarian suspects that an adverse reaction is related to the use of an NSAID or any drug, it should be reported to the pharmaceutical company. Usually, the veterinarian reports it, but if the veterinarian doesn't, the owner should. The company, by law, has to report all adverse reactions to the FDA, which looks for signals of increased frequency and severity of adverse reactions. The FDA works with the pharmaceutical firms to address these events and improve the ability of the product to be more safely used.
If unable to report problems directly to the pharmaceutical company, veterinarians and owners are encouraged to report veterinary Adverse Drug Experiences (ADEs) and suspected product failures to the government agency that regulates the product. Adverse experiences with NSAIDs should be reported to the FDA's CVM.
Michele Sharkey, D.V.M., of the FDA's Office of New Animal Drug Evaluation, contributed to this article.
________________________________________
Medicate Under Veterinary Supervision
The FDA has approved some nonsteroidal anti-inflammatory drugs (NSAIDs) for use in dogs. In the United States, there are no oral NSAIDs approved for use in cats. Veterinarians can, however, legally prescribe human drugs to animals unless it presents a risk to the public health. This type of use is known as extralabel, or off-label, for uses not listed on the label. Extralabel use can also mean prescribing a drug to a different species, for a different condition, or in a different dosage than that for which the drug was approved. For example, a veterinarian may prescribe a lower dose of an NSAID drug approved for dogs to a cat with an inflamed joint.
But pet owners should not give their own drugs to pets or otherwise medicate their animals without veterinary supervision, says Michele Sharkey, D.V.M., in the FDA's Center for Veterinary Medicine.
Different species metabolize drugs differently, she says. "You take aspirin or Tylenol on any given day for a headache and not think twice about it, but dogs are more sensitive to aspirin than humans, and one Tylenol can kill a cat. Pet owners should always work with their veterinarians to make medication decisions."
________________________________________
FDA-Approved NSAIDs for Use in Dogs
Brand name Established name Manufacturer/
distributor and year of FDA approval Indication Type of dosage Manufacturer's telephone number for assistance or to report suspected adverse reaction
Etogesic etodolac Fort Dodge Animal Health, 1998 management of pain and inflammation associated with osteoarthritis in dogs tablet (800) 533-8536
Rimadyl carprofen Pfizer Animal Health, 1996 (caplet); 1999 (tablet); 2003 (injectable) relief of pain and inflammation associated with osteoarthritis in dogs; control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs caplet and chewable tablet; injection (800) 366-5288
Deramaxx deracoxib Novartis Animal Health US Inc., 2002 control of pain and inflammation associated with osteoarthritis in dogs; control of postoperative pain and inflammation associated with orthopedic surgery in dogs 4 lbs or greater chewable tablet (800) 332-2761
Metacam meloxicam Boehringer Ingelheim Vetmedica Inc., 2003 (oral suspension, and injectable) control of pain and inflammation associated with osteoarthritis in dogs drops given by mouth; injection (866) METACAM (638-2226)
Zubrin tepoxalin Schering-Plough Animal Health Corp., 2003 control of pain and inflammation associated with osteoarthritis in dogs rapidly disintegrating tablet (800) 224-5318
Previcox firocoxib Merial Ltd., 2004 control of pain and inflammation associated with osteoarthritis in dogs chewable tablet (877) 217-3543
Novox generic carprofen IMPAX Laboratories Inc./Vedco Inc., 2005 relief of pain and inflammation associated with osteoarthritis in dogs caplet (888) 708-3326
U.S. Food and Drug Administration
________________________________________
Questions regarding ADE reporting should be addressed to:
Center for Veterinary Medicine
Division of Surveillance, HFV-210
7519 Standish Place
Rockville, MD 20855
(888) FDA-VETS (332-8387)
_______________________________________

10-04-2009, 05:23 AM	#27
dwerten BANNED! Join Date: May 2007 Location: USA Posts: 11,073	When giving a pet an NSAID, watch for these side effects, which are listed on the Client Information Sheet and on the drug label: • Decrease or increase in appetite • Vomiting • Change in bowel movements (such as diarrhea or black, tarry, or bloody stools) • Change in behavior (such as decreased or increased activity level, seizure, aggression, or lack of coordination) • Yellowing of gums, skin, or whites of the eyes (jaundice) • Change in drinking habits (frequency or amount consumed) • Change in urination habits (frequency, color, or smell) • Change in skin (redness, scabs, or scratching). These side effects are the most common. But not all possible side effects are included on the Client Information Sheet or on the drug label. Always contact your veterinarian if you have questions about your dog's medication. What starts out as a minor problem can rapidly progress to an emergency. An owner should be encouraged to call his or her veterinarian with any concerns about the NSAID the dog is receiving. You may even call the drug manufacturer's toll-free number that appears on each Client Information Sheet. When problems are experienced with a product, the manufacturer may have specific recommendations for your veterinarian regarding tests and treatments. Cindi Brinkley of Danville, Ill., rushed her dog to the veterinarian at the first sign of a bad reaction. Maude, a cocker spaniel-collie mix, injured herself when she was 11 months old while playing with a littermate in the house. "She slipped on the basement floor coming out of a turn, and both back legs splayed out," says Brinkley. Maude was diagnosed with a deformed hip joint and scheduled for corrective surgery. In the meantime, the veterinarian prescribed an NSAID for pain control. "I was not told a thing about the drug other than how to give it to her," says Brinkley. Maude had been on the drug for a month when Brinkley came home from work one day to find the dog bleeding from her rectum. "It was very, very frightening," she says. "The whole back of my dog was bright red--I thought she was bleeding to death." After treatment in the veterinary hospital and discontinuation of the drug, Maude recovered from the incident. Now more than 7 years old, "she has some vomiting and loose stools every so often," says Brinkley, who suspects the digestive problems may be a lasting effect of the drug. Report Bad Reactions If you or your veterinarian suspects that an adverse reaction is related to the use of an NSAID or any drug, it should be reported to the pharmaceutical company. Usually, the veterinarian reports it, but if the veterinarian doesn't, the owner should. The company, by law, has to report all adverse reactions to the FDA, which looks for signals of increased frequency and severity of adverse reactions. The FDA works with the pharmaceutical firms to address these events and improve the ability of the product to be more safely used. If unable to report problems directly to the pharmaceutical company, veterinarians and owners are encouraged to report veterinary Adverse Drug Experiences (ADEs) and suspected product failures to the government agency that regulates the product. Adverse experiences with NSAIDs should be reported to the FDA's CVM. Michele Sharkey, D.V.M., of the FDA's Office of New Animal Drug Evaluation, contributed to this article. ________________________________________ Medicate Under Veterinary Supervision The FDA has approved some nonsteroidal anti-inflammatory drugs (NSAIDs) for use in dogs. In the United States, there are no oral NSAIDs approved for use in cats. Veterinarians can, however, legally prescribe human drugs to animals unless it presents a risk to the public health. This type of use is known as extralabel, or off-label, for uses not listed on the label. Extralabel use can also mean prescribing a drug to a different species, for a different condition, or in a different dosage than that for which the drug was approved. For example, a veterinarian may prescribe a lower dose of an NSAID drug approved for dogs to a cat with an inflamed joint. But pet owners should not give their own drugs to pets or otherwise medicate their animals without veterinary supervision, says Michele Sharkey, D.V.M., in the FDA's Center for Veterinary Medicine. Different species metabolize drugs differently, she says. "You take aspirin or Tylenol on any given day for a headache and not think twice about it, but dogs are more sensitive to aspirin than humans, and one Tylenol can kill a cat. Pet owners should always work with their veterinarians to make medication decisions." ________________________________________ FDA-Approved NSAIDs for Use in Dogs Brand name Established name Manufacturer/ distributor and year of FDA approval Indication Type of dosage Manufacturer's telephone number for assistance or to report suspected adverse reaction Etogesic etodolac Fort Dodge Animal Health, 1998 management of pain and inflammation associated with osteoarthritis in dogs tablet (800) 533-8536 Rimadyl carprofen Pfizer Animal Health, 1996 (caplet); 1999 (tablet); 2003 (injectable) relief of pain and inflammation associated with osteoarthritis in dogs; control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs caplet and chewable tablet; injection (800) 366-5288 Deramaxx deracoxib Novartis Animal Health US Inc., 2002 control of pain and inflammation associated with osteoarthritis in dogs; control of postoperative pain and inflammation associated with orthopedic surgery in dogs 4 lbs or greater chewable tablet (800) 332-2761 Metacam meloxicam Boehringer Ingelheim Vetmedica Inc., 2003 (oral suspension, and injectable) control of pain and inflammation associated with osteoarthritis in dogs drops given by mouth; injection (866) METACAM (638-2226) Zubrin tepoxalin Schering-Plough Animal Health Corp., 2003 control of pain and inflammation associated with osteoarthritis in dogs rapidly disintegrating tablet (800) 224-5318 Previcox firocoxib Merial Ltd., 2004 control of pain and inflammation associated with osteoarthritis in dogs chewable tablet (877) 217-3543 Novox generic carprofen IMPAX Laboratories Inc./Vedco Inc., 2005 relief of pain and inflammation associated with osteoarthritis in dogs caplet (888) 708-3326 U.S. Food and Drug Administration ________________________________________ Questions regarding ADE reporting should be addressed to: Center for Veterinary Medicine Division of Surveillance, HFV-210 7519 Standish Place Rockville, MD 20855 (888) FDA-VETS (332-8387) _______________________________________