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Vets Lax on Deramaxx Consent, FDA Says

Monday, July 28, 2003

A cavalier attitude among veterinarians toward prescribing Deramaxx (deracoxib) may be resulting in unnecessary adverse experiences, according to the Food and Drug Administration's Center for Veterinary Medicine.

More than 300 adverse drug experience (ADE) reports for the Novartis drug had been reported to the CVM as of June 4, 2003. Many callers to the ADE hotline said they never received an information sheet from their veterinarian, according to the FDA.

"There has been full disclosure [about the drug's side effects] by the FDA and the manufacturer, but not necessarily by veterinarians," the FDA said via e-mail.

"Many of the callers and reporters to the CVM hotline tell us that they never received a client information sheet, their dog never had pre-drug blood testing, and/or their veterinarian denied that the side effects could be attributed to the drug even though the side effects are noted on the client information sheet and the label."

Deramaxx is a non-steroidal anti-inflammatory cox-2 inhibitor indicated for the postoperative pain and inflammation associated with orthopedic surgery in dogs and for the control of pain and inflammation associated with osteoarthritis in dogs, according to Novartis.

Some of the most common side effects reported to the FDA are vomiting, anorexia, elevated kidney and liver blood values and diarrhea. ADE reports, listed on the FDA's Web site at www.fda.gov/cvm/index/ade/ADEReport.htm, highlight signs, frequency and the number of deaths associated with a drug reaction. To date, 79 dogs have died while taking Deramaxx. Although these deaths have not been linked to Deramaxx usage, the FDA considers the number low.

"Most of the effects that have been seen are well known to occur with all non-steroidal anti-inflammatory drugs. [The effects] are all mentioned in the client information sheet. They are predictable and associated with off-label use or in dogs who are not good candidates," the FDA said.

Dr. John Cary, manager of technical services for Novartis Animal Health, said that the ADE reports for Deramaxx are consistent with the company's expectations and that the number of reports were low considering the number of dogs taking the drug.

There has been consumer backlash at the FDA and Novartis on several Internet sites as the number of Deramaxx ADE reports increase.

"Consumers should know that with time and new drugs, labels can change post-marketing information that may include new concerns. [Consumers] should always look for the most recent information," the FDA said. "Veterinarians are required to hand out client information sheets under an informed consent practice that is inherent in good clinical practice but not mandated in any form except by various state practice acts. These are understood professional standards of conduct."

Novartis made the decision to distribute a CIS with the Deramaxx label even though the FDA did not require that one be included, according to Dr. David Stansfield, director of professional services at Novartis Animal Health. He said that the information sheets are a friendly way of explaining, in lay terms, to the consumer the drug's possible side effects and appropriate conditions under which a pet should be given the drug.

"We have distributed 4 million client information sheets and I think that veterinarians are distributing them responsibly to their clients," Dr. Stansfield said.

However, when a dog has a reaction to the drug, Novartis is aggressively investigating and documenting reports.

"We will provide to consumers, on a case by case basis, the financial support needed for diagnostics to investigate whether or not the drug caused an adverse reaction," Dr. Cary said.

Stansfield said that Novartis continues to invest in educating veterinarians on current and upcoming information on Deramaxx. He said the responsibility ultimately lies with veterinarians to dispense the drug responsibly.-Somyr McLean END QUOTE

A look at RIMADYL - SEE: http://www.fda.gov/cvm/index/updates/rimadyl2.html

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CVM UPDATE - DECEMBER 1, 1999

Most of the ADEs reported by owners directly to CVM involved owners of dogs who said they were not aware of the potential adverse effects associated with RimadylŪ use. Adequate communication between the veterinarian and client should result in an awareness of the risk and benefit of drug use and alternate therapies that are available. Additionally, communication should establish the importance of evaluation of the dog prior to RimadylŪ initiation and the necessity of periodic follow-up evaluations if drug use is continued long-term. Animal owners have told CVM that adequate communication is not occurring in many instances END QUOTE

From: http://www.fda.gov/fdac/features/2000/600_pets.html

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FDA has helped two animal pharmaceutical companies develop consumer-friendly labels that explain the benefits and risks of their osteoarthritis drugs for dogs. Fort Dodge Animal Health of Overland Park, Kan., distributes a "client information sheet" with EtoGesic (the generic drug etodolac). Pfizer Animal Health, Inc., of Exton, Pa., gives out a client information sheet with Rimadyl (carprofen). Both drugs are non-steroidal anti-inflammatory drugs (NSAIDs).Pfizer provided the Rimadyl information at CVM's request following a high volume of adverse events, including deaths, reported by owners whose dogs were treated with the drug. The angry owners, who were not properly informed of the drug's risk, prompted the new labeling that will better help other pet owners decide if the drug is appropriate for their dogs. END QUOTE

The FDA suggested that Pfizer prepare an "Information Sheet" to send to vets - this sheet is to be given to persons who are prescribed Rimadyl for their dog. (The FDA refers to this information sheet in their December 1, 1999, Update.)

Pfizer wrote a "Dear Doctor" letter in March 2000 - with information on the Client Information Sheet:

http://www.fda.gov/cvm/index/safety/4045.htm

The information sheet, etc. may be viewed at:

http://www.fda.gov/cvm/index/currentlabels/141053cis.pdf

Channel 5 TV in Phoenix, Arizona ran a segment on Rimadyl (Another NSAID) that aired Monday, May 21, 2001 - it can be read on the web at:

http://www.kpho.com/Global/story.asp?s=343171

The following statement is taken from the above URL:

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The FDA says it insisted that Pfizer include the word "death" in their Rimadyl commercials. The Administration says Pfizer didn't want to use the word death -- and pulled their ads instead. Pfizer added an insert to the Rimadyl packaging which does include the word "death," but people like Paul Michelfelder say it's not informative enough. "Had a vet told me a possible side effect was liver damage, there's no way I would have put that dog on that drug. No way." The FDA also told 5 Investigates that "Veterinarians are now the weakest link in the Rimadyl chain." The FDA is planning to try to further educate vets on the potential dangers of Rimadyl. END QUOTE