Thursday, July 16, 2009

WARNING: FDA Recalls Certain Wormer Pellets in Missouri and Arizona

Here is the text of a warning published by the US Food and Drug Administration in their Enforcement Report for this week:

PRODUCT
Horse and Colt Wormer packaged in 16-oz. containers under 5 private labels, containing 1.25% pyrantel tartrate (equivalent to 5.671 grams per pound), NADA 092-150. The products were marketed under the following brand names:
(1) Kaeco Equine Wormer Pellet for Horses and Colts;
(2) Manna Pro Foal & Horse Pelleted Wormer;
(3) Durvet Horse & Colt Wormer, NDC 30796-490-31;
(4) Farnam Pellet Care P Equine Wormer Pellet;
(5) Sportsman's Friend Colt and Horse Wormer.
Recall # V-234-2009
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Virbac AH, Inc, Fort Worth, TX, by e-mail on March 9, 2009 and by letters on April 29, 2009.
Manufacturer: Virbac, Inc, Bridgeton, MO. Firm initiated recall is ongoing.
REASON
Stability failures (subpotent)
VOLUME OF PRODUCT IN COMMERCE
237,708/1-lb. cans
DISTRIBUTION
Missouri, Arizona

While the reason given for the recall is "stability" or that the wormer is not fully potent, it is still not a good idea to use it and the manufacturer would like to know that as many of the sold items are accounted for as possible. They are legally bound to comply with the FDA recall terms.

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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Wednesday, June 24, 2009

Five-Time German Dressage Olympian's Horse Tests Positive for Banned Medication

Just a few weeks ago, Germany's equestrian federation sent seismic shock waves through the horse showing world by disbanding its national teams after show-jumping riders began to tell shocking tales of medication and manipulation of their horses to bring home gold medals. Germany promised heads would roll.

So this morning's news was more shocking than ever, read through that lens.

According to the Associated Press and confirmed by Horse and Hound and English-language newspapers in Germany, double Olympic gold medalist Isabel Werth has been suspended from competition and will attend a hearing later this week to answer charges that her horse Whisper tested positive for an anti-psychotic medication at the competition at Wiesbaden on May 30, 2009.

“This is a catastrophy for equestrian sports," said Breido Graf zu Rantzau, president of the equestrian federation, in the Associated Press report.

All sources confirm that Isabel has been suspended; however the system includes a backup: the "B" sample may still be tested and prove her innocent of illegal doping. While the investigation continues, she will not be able to compete at Aachen, the biggest competition for German riders in the run-up to this summer's European Dressage Championships.

Should the "B" sample test positive, Werth would face punishment by both the FEI and German authorities.

Up to this time, most emphasis on doping has centered on show jumping.


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Monday, September 22, 2008

Guilty as Charged: Mythilus and King-Dye, US Dressage Team Punished in Olympic Medication Violation Decision

Because of the serious nature of this story, I will share with you the decision as it was issued by the Federation Equestre International (FEI) today. Sorry I can't report a happy ending to this ongoing story.

Thanks to Malina Gueorguiev of the FEI who writes:

Today the FEI Tribunal has issued its decision in the Positive Medication Case involving the horse MYTHILUS ridden by Ms Courtney King-Dye, the person responsible ("PR"), and representing the US Dressage Team at the 2008 Olympic Games in Hong Kong.

The horse was sampled at the Olympic Games on 19 August 2008 and tested positive for Felbinac. Felbinac is a non-steroidal anti-inflammatory drug (NSAID) used to reduce inflammation and pain and, accordingly, is classified as “Medication A” Prohibited Substances under the FEI Equine Prohibited List (VR Annex III).

At a preliminary hearing held during the Olympic Games on 22 August 2008 it was decided to maintain the provisional suspension until the final decision of the case.

The hearing in this case was held at the FEI Headquarters on 7 September 2008. Before and during the hearing the PR presented testimonies and legal arguments and the United States Equestrian Federation ("USEF") requested that in case of a decision against the PR, the US Dressage Team does not forfeit its 4th place at the Olympic Games.

The Tribunal was satisfied that the laboratory reports relating to both the A-Sample and the B-sample reflect that the analytical tests were accurately performed in an acceptable method and that the findings of the laboratory were accurate. The FEI Tribunal was satisfied that the test results evidenced the presence of Felbinac.

The Tribunal did not accept the PR's argument that the exception contained in Equine Anti Doping and Medication Control Rules ("EADMCR") Article 2.1.3 to a medication rule violation in case of an environmental contamination should apply, since Felbinac did not appear on the Equine Prohibited List as a threshold substance and no specific criteria was established for it on such List as a contaminant.

The Tribunal repeated its stand that the FEI policy in regard to doping and medication does not only intend to ensure a level playing field but has the additional policy consideration of ensuring that the welfare of the horse is maintained and that horses compete only when they are physically fit and capable of competing. This requires doping and medication rule violations to be strict liability or no fault offences. The PR's arguments that she had gained no competitive advantage and that the findings did not constitute any maltreatment of the horse, due to the nature of the substance and the minimal concentration detected, were therefore not relevant.

The Tribunal accepted the FEI's position that, under the clear language of EADMCR Article 10.5, in order for the PR to prove that she bears no fault and no negligence and that the sanctions should be eliminated, she must demonstrate how the substance entered the horse's systems. While elaborate, the explanations furnished by the PR were only speculations.

As a result of the foregoing, the horse and the PR are disqualified from the Games and all medals, points and prize money won at the Olympic Games by them are forfeited. Such disqualification is automatic and is not considered a sanction; rather it is an automatic mechanism used to ensure a level playing field.

As a result, the US Dressage Team with its remaining two competitors is also disqualified and loses its 4th place. The Tribunal did not accept the arguments of the USEF that the resulting disqualification of its Team, when the sampling was carried days after the end of the Team competition, is a "sanction" which is inappropriate in this case and should not be imposed. The Tribunal noted that the resulting disqualification was automatic.

In regard to sanctions, the Tribunal considered the fact that the PR is an experienced sportswoman and that the behaviour of anyone at the top of the sport and particularly at the Olympic Games must be faultless since the eyes of the world focus on performances at such events.

On the other hand, the Tribunal found the evidence of the PR and the US Dressage Team Vet to be credible and believed that neither the PR nor anyone on her behalf or related to the USEF had knowingly administered the medication to the horse. The Tribunal further accepted the PR's and USEF's arguments that they have done almost everything in their power to ensure that no rule violation shall occur. The Tribunal also considered the type of Medication A substance involved and its therapeutic applications, the fact that the same substance may not be considered as a doping substance, the specific circumstances relating to the horse's hospitalization in Hong Kong and the possibility of contamination, the excellent stable management practiced by the US team and measures placed to try and ensure the no horse with prohibited substances participates at the Olympic Games, the efforts made by the PR and the USEF to determine the source of the positive finding, the impeccable record and reputation of the PR, the PR’s cooperation in the investigation and the hardship already caused to the PR including the fact that the US Dressage Team has already lost its 4th place at the Olympic Games.

As a consequence, the Tribunal imposed on the PR a one month suspension, which has commenced on the date of the application of the provisional suspension and ended on 21 September 2008, fine and costs.

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Sunday, July 27, 2008

Post-Arrival Drug Testing Offered for Olympic Horses


No one wants to lose a medal won at the Olympics because of a bad drug test on a horse. And it has happened...remember Athens in 2004?

Many horses are treated with legitimate medications, while others have been treated with medications that are not allowed for competition. One of the tricky aspects of preparing a horse for competition is knowing when the drug's traces will leave the horse's symptoms. Vets have guidelines to go by, but it is always a gamble.

Another thing that happens at competitions is that trace elements show up in drug tests that are a complete mystery. We hear all sorts of conjecture about substances that may be on feed tubs or that the horse absorbs through the skin from rubdowns or hoof treatments. There is also the implied threat of sabotage.

This year at the Olympics, horses are being offered optional drug tests upon their arrival. These tests have to be made by collecting urine within 12 hours of arrival in Hong Kong.

These drug tests are not legally binding, but riders and coaches and owners will know if a horse tests for a given substance. Some horses may be coming off medications and have plenty of time to be "clean" by the time that the competitions begin. An example would be lidocaine, a local anesthetic, or a steroid used to clear up a skin condition.

The system is called PAET, for Post-Arrival Elective Testing, and this is the first time it has been offered.

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