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FDA slams Novartis on dog painkiller

Agency says drugmaker withheld data showing deaths with drug similar to Vioxx.
December 28, 2004: 12:54 PM EST

WASHINGTON (Reuters) - Novartis AG failed to give the government prompt, accurate reports about deaths of dogs treated with a painkiller in the same class of medicines now linked to heart problems in humans, U.S. regulators have charged in a letter.

Novartis (up $0.23 to $50.33, Research) officials could not immediately be reached for comment.

The drug, Deramaxx, is a COX-2 inhibitor approved for relieving arthritis and post-surgical pain in dogs.

Similar drugs for people are under heavy scrutiny after studies associated them with heart attacks and strokes. One of the drugs, Merck & Co. Inc.'s (up $0.33 to $32.28, Research) Vioxx, was pulled from the market because of safety risks.

Death has been reported "in rare situations" when dogs were treated with Deramaxx, according to the drug's label instructions.

The Food and Drug Administration, in a warning letter dated Nov. 29, said Novartis Animal Health Services should have forwarded complaints about deaths and health problems in dogs given Deramaxx within 15 working days, but in some cases delayed as long as 10 months. Some reports, including ones involving deaths, appeared to have incorrect dates, the FDA said.

"Novartis failed to submit timely and accurate information to the FDA regarding serious (adverse drug experiences) associated with the administration of its FDA-approved animal drug product Deramaxx ... during its first year of marketing," the FDA said.

The company also failed to submit proper information about post-approval studies of Deramaxx, the FDA charged. The drug is known generically as deracoxib.

The FDA sends dozens of warning letters per year. Most of the issues raised are resolved without further regulatory action, although the letters sometimes lead to tougher steps such as product seizures.  

Understanding Deramaxx®

Smart Drug or Clever Marketing?

Silk, my 9 year old Dobie, injured her left rear leg and was prescribed Deramaxx® which she took for just two days. Needless to say, three days and $1,500.00 dollars later, the specialists are still giving her IV fluids. A scope was performed today by an internal medicine specialist who found that the entire stomach lining had been sloughed off. Her symptoms were violent vomiting which included blood, bloody stool and bleeding from the rectum. IV fluids will be maintained for at least two more days, which will make that a total of 5 days on IV fluids.
Cheryl Hartman
As of March 14th, Cheryl's bill for treating Silk is now $3,470.53.

Deramaxx® is a non-steroidal anti-inflammatory (NSAID) marketed by
Novartis Animal Health Products. The essence of the Novartis marketing campaign is that because Deramaxx® is a Cox-2 specific NSAID it is both safer and more effective than other veterinary NSAIDs. Claims like this have been disallowed by the Food and Drug Administration for human Cox-2 inhibitors. Cox-2 inihibitors simply trade one set of side effects for another.

As with any NSAID, it is a medicine to be taken wisely since the side effects can include death.

As of February 24, 2003, the Center for Veterinary Medicine of the Food and Drug Administration had received reports of the death of 27 dogs which were possibly linked to Deramaxx®. Reported adverse events typically represent about 10%-15% of actual events.
This website has been created to provide information on using Deramaxx® intelligently and dealing with problems should they arise. The information presented on this site is intended to assist pet owners in making intelligent decisions regarding the use of Deramaxx®. It is not veterinary advice. Owners need to work closely with their veterinarians in deciding whether to use Deramaxx® and in treating their companions if they experience an adverse reaction.
© Copyright 2003. Edward Murray. All rights reserved.
Material on this site may be freely copied provided a link is provided to the site.

May my beloved partner ROMI rest in peace  - no matter wherever her bits and pieces/frozen carcass may be held hostage.


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