ROMI's Website

 

You may return to the index by clicking here, http://rimadyldeath.com, or by using your 'back' browser.

If you've 'lost' a pet after RIMADYL was given/adminisrered by your trusted veterinarian, please DON'T take on the guilt along with your grief!

 

The music for this page is "Send in the Clowns". 



from:  http://www.fda.gov/cvm/Documents/PfizerLtr112408.pdf

 

[FDA/CVM letterhead]

Food and Drug Administration
Rockville MD 20857

NOV 24, 2008

NADA 141-111
NADA 141-053
NADA 141-199
 

M. Elizabeth McKenzie, PhD Director,
US Regulatory Affairs Pfizer Inc,
Animal Health Group
150 East 42nd Street, 39-05
New York, NY 10017

 
RE: NADA 141-053, 141-111, 141-199 -Rimadyl® caplets, chewable tablets, and injectable solution for dogs

 
Dear Dr. McKenzie:

The U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Division of Surveillance has reviewed your February 20, 2008, Drug Experience Report (DER) concerning Rimadyl® (carprofen) caplets, tablets, and injectable solution, NADAs 141-053, 141-111, and 141-199. This submission includes six meter boards (RIMlO06116). These boards are false or misleading because they make unsubstantiated safety claims and minimize the risk associated with Rimadyl®.

CVM has also reviewed an advertisement that appeared in the May 2008 DVM Newsmagazine (RIM1206128R) that is false or misleading because it makes unsubstantiated safety claims and minimizes these risks associated with Rimadyl®.

Finally, CVM has reviewed your April!l, 2008, DER submission. This submission includes a Duration of Efficacy chart (RIM1207134). This item is false or misleading because it makes unsubstantiated efficacy claims regarding Rimadyl®.

For these reasons, Rimadyl® is misbranded within the meaning of section 502(n) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 352(n)].

Background: Rimadyl® (carprofen) is a non-steroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and-orthopedic surgeries in dogs. Rimadyl® is approved for use at a dose of 2 mg/lb of body weight once daily or divided and administered as I mg/lb twice daily.

Unsubstantiated Claims:  The meter boards, RIMI006116, state that "Rimadyl (carprofen) has been proven safe at 5.7 times the recommended dose for up to 52 weeks." We are aware that this particular advertisement has been used as recently as June 2008 at the trade show for the forum for the American College of Veterinary Internal Medicine in San Antonio, Texas. The statement is accompanied by a disclaimer, in fine print, indicating that "Pfizer Animal Health does not endorse use higher than the recommended dose of 2 mg/lb/day." The fine print disclaimer goes on to explain, "In a clinical study, at doses as high as 5.7 times the labeled amount for 52 straight weeks, no gross or histologic changes were seen in any treated dogs."  This claim implies that Rimadyl® is safe for use at 5.7 times the recommended dose when this has not been demonstrated by substantial evidence of safety. The claim is supported by a citation to Rimadyl Freedom of Information Summary, NADA 141-053, Pfizer Animal Health, Report Nos.. N-29736 and N-30191. This study of healthy animals had a stated purpose ~~to assess the toxicity of [Rimadyl®]," not to prove the safety of Rimadyl® when used at doses greater than those indicated on the label for the relief of pain and inflammation associated with osteoarthritis and for the control of postoperative pain associated with soft tissue and orthopedic surgeries in dogs. The claim is therefore misleading because it contains a representation or suggestion, not approved or permitted for use in the labeling, that Rimadyl® is safer than has been demonstrated by substantial evidence or substantial clinical experience. See 21 C.F.R. 202.1 (e)(6)(i). Not only is this statement misleading, it also sends a dangerous message to veterinarians by suggesting an overdose (> 1 times dose) is safe. Veterinary patients may be injured by being given an unapproved overdose.

The advertisement (RIMI206128R) published in the May 2008 edition of DVM Newsmagazine included the statement, "Proven safe in a 5 year compassionate use study." This advertisement apparently refers to a report entitled "Extended-use studies of carprofen in dogs", a description of which appears in the Rimadyl Freedom of Information Summary, NADA 141-053, Pfizer Animal Health. The stated purpose of this particular study was to "allow for the"continued (compassionate) use of carprofen in dogs previously enrolled in clinical efficacy studies and to survey the safety of repeated use," not to prove the safety of the drug. Therefore, the claim that the drug was "proven safe" in this study is misleading because it contains a representation or suggestion, not approved or permitted for use in the labeling, that Rimadyl® is safer than has been demonstrated by substantial evidence or substantial clinical experience. See 21 C.F.R. 202. 1(e)(6)(i). I

Finally, the Duration of Efficacy chart includes the statement, "Rimadyl® has a quick
onset of action with a long duration of efficacy" and presents 'pharmacokinetic data
including Tmax of both subcutaneous and oral administration. This data is apparently
drawn from a study by Clark, TP, et al.I.  However, the Tmax data presented in this study
1 Clark, TP, Chieffo C, Huhn JC, et al. The steady-state pharmacokinetics and bioequivalence of carprofen administered orally and subcutaneously in dogs. 1. Vet. Pharmacology Ther. 2003; 26: 187-192. does not necessarily correlate with clinical analgesic effect because the study does not address analgesic effects of Rimadyl®. Instead, this study addresses the pharmacokinetics and bioequivalence of the different forms of administration of Rimadyl®. A demonstration of analgesic effect would typically require testing the pain threshold of dogs at given time intervals after the administration of the product. Therefore, this claim is misleading because it presents a favorable conclusion from a non clinical study for which clinical significance has not been demonstrated in a way that suggests the conclusion has clinical significance. See 21 C.F.R. 202.1 (e)(6)(vii).

Conclusion and Requested Action:  The misleading statements in your advertisements misbrand Rimadyl® within the meaning of section 502(n) of the Act, 21 U.S.C. 352(n).  The Center for Veterinary Medicine requests that Pfizer Animal Health immediately cease the dissemination of the Rimadyl® promotional items described above, and any other·materials that may contain similar unsubstantiated promotional claims.
 
Please submit a written response within thirty (30) days of receipt of this letter describing whether you intend to comply with this request, and listing all violative promotional materials for Rimadyl® the same as or to those described above, and explaining your plan for discontinuing use of such materials.

Please direct your response to me at the Food and Drug Administration, Center for Veterinary Medicine, Division of Surveillance, HFV-210, 7519 Standish Place, Rockville, MD 20855. We remind you that only written communications are official.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to see that your promotional materials for Rimadyl®, as well as other Pfizer Animal Health products, comply with the requirements of the Act and FDA implementing regulations.

Sincerely yours,
 

Lynn O. Post, DV M, PhD, D
BVT Director, Division of Surveillance HFV-21O
Center for Veterinary Medicine


The WHY of pets killed by Rimadyl is easy:  PROFIT!

Here's HOW it's happened and continues to happen:

The drug companies are probably the most powerful 'lobby' in our country, even having suffient power to place 'caps' on the amount of money a patient is 'allowed' to recover from a drug company today and undoubtedly all operate in the same manner.  Pfizer, and the rest of them, are in business to make money; 'profit' is the bottom line. 

While knowing/understanding what has happened and who the 'guilty parties' are, nothing is going to bring your beloved pet back; BUT here are some proactive things to consider:


 


from:  http://www.buav.org/downloads/pr/PR_2009_02_Dog_Obesity_Drug.pdf 

[BUAV letterhead]

PRESS RELEASE

Hundreds of dogs suffered and many were killed in tests for canine

“lifestyle” drug

2nd February 2009

The British Union for the Abolition of Vivisection (BUAV) and the Irish Anti-

Vivisection Society (IAVS) have exposed the plight of almost 300 dogs to test the effects of dirlotapide (Slentrol®), a drug recently marketed to manage canine obesity.

In the experiments carried out by drug company Pfizer, hundreds of dogs suffered and at least 73 were killed. Most of the experiments took place in the USA. One experiment, carried out by Pfizer UK (based in Sandwich, Kent), involved Labrador retrievers and took place in Ireland.

The studies, published in recent scientific literature, revealed that 114 Labradors retrievers and 175 beagles were given dirlotapide. Some of the experiments continued every day for up to a year and many of the dogs were housed individually, with no mention of exercise or social interaction. In at least one test, the drug was given by gavage (the forcing of a tube down the throat or through the nose into the stomach).

Some dogs were also subjected to invasive abdominal surgery to implant tubes. In most of the experiments, some dogs experienced diarrhoea and vomiting.

The source and fate of many of the dogs was not mentioned. In the experiment published by Pfizer, UK, 114 Labrador retrievers were dosed every day with the drug for up to 52 weeks.* It was not revealed where the dogs came from, how they came to be overweight or obese at the start of the experiment, or what happened to them when the experiment was over.

It was noted by the researchers that once the drug is discontinued, there would be rebound weight gain unless an appropriate diet and exercise regimen is instituted. It should be obvious, therefore, that the latter could have resulted in the same weight loss caused by the drug.

Chief Executive of the BUAV, Michelle Thew, says “Pet owners everywhere will be shocked to learn that hundreds of dogs, such as beagles and Labrador retrievers, suffered and many were killed just to study the effects of an unnecessary drug. Pfizer's stated commitment to the health and wellness of pets has to be called into question here. In these experiments, dogs who could otherwise be members of a loving family, were treated as disposable research tools. At the end of the day the answer to helping overweight pets is a restricted diet and regular exercise - everyone knows that.”

IAVS Spokesperson, Yvonne Smalley, says "Animal experiments in Ireland are governed by the Cruelty to Animal Act 1876, as amended by EU Regulations 2002 & 2005. Licences are granted subject to the experiment being essential and the objective can not be achieved by the use of alternative techniques. The scientific value of the outcome must be deemed to outweigh the suffering to the animals involved (e.g. licences are not granted to conduct cosmetics testing in Ireland). On this basis, the IAVS believes this work should not have been licensed. We call on the Department of Health to suspend any current licence for ongoing or similar experiments immediately, pending a full investigation into the use of these dogs, the conditions in which they are held and what is happening to the surviving dogs today."

Veterinary Consultant to the BUAV, Dr Nedim Buyukmihci, says “In my professional opinion, the published literature fails to demonstrate a medical benefit for Slentrol that cannot be achieved through other safer and more sustainable means such as good pet nutrition and regular exercise. To cause dogs to suffer or to kill them to produce a drug that is nothing more than for convenience is morally unacceptable.”

NOTES TO EDITORS

*Gossellin, J.; Peachey, S.; Sherington, J., Rowan, T.G. and Sunderland, S.J. Evaluation of dirlotapide for sustained weight loss in overweight Labrador retrievers. Journal of Veterinary Pharmacology and Therapeutics 2007;30;55-65.

The Chief Executive of the BUAV, Michelle Thew, is available for interview.

The BUAV has been campaigning for over 100 years to achieve a world where nobody wants or believes we need to experiment on animals. We are committed to achieving our aims through reliable and reasoned evidence-based debate. We are proudly non-violent and respect the quality of life for all – animals and people.

For more information contact: Carla Owen +44 (0)20 7619 6965/Out of

hours mobile: +44 (0)7850 510955 /Email: Carla.Owen@buav.org

 


May my beloved partner ROMI rest in peace  -

no matter wherever her bits and pieces/frozen carcass may be held hostage.

 

[What's in YOUR "urn"?]

Copyright: 2004 Ginger Sanchez. All Rights Reserved.

This Website Built and Hosted for Free at
Bravenet.com