Thursday, April 30, 2009

Update: Polo Pony Deaths / Selenium Overdose to Blame

UNDIAGNOSED POISONING, EQUINE - USA (05): (FLORIDA) SELENIUM
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A ProMED-mail post

ProMED-mail is a program of the
International Society for Infectious Diseases


[1]
Date: Tue 28 Apr 2009
Source: Yahoo News, Associated Press (AP) report [edited]



Officials blame mineral overdose in horse deaths
------------------------------------------------
Florida's top veterinarian on Tuesday [28 Apr 2009] blamed the deaths
of 21 elite polo horses on an overdose of a common mineral that helps
muscles recover from fatigue.

Florida's state veterinarian, Dr Thomas J Holt, said toxicology tests
on the dead horses showed significantly increased selenium levels.

The horses from the Venezuelan-owned Lechuza Caracas team began
collapsing [19 Apr 2009] as they were unloaded from trailers at the
International Polo Club Palm Beach in Wellington before a
championship match. Some died at the scene, others hours later.

"Signs exhibited by the horses and their rapid deaths were consistent
with toxic doses of selenium," Holt said.

The team was preparing to play in the sport's US Open and was seen as
a top contender.

A Florida pharmacy that mixed a brew of vitamins and minerals for the
team on order from its Florida veterinarian said Tuesday [28 Apr
2009] that the strength of selenium was incorrect. Jennifer Beckett,
chief operating officer for Franck's Pharmacy in Ocala, Florida,
would not say whether the incorrect amount was specified in the
veterinarian order or was a pharmacy error. "We continue to cooperate
fully with the authorities as their investigations proceed," she
said. "We cannot discuss further details." Lechuza had no comment on
the toxicology report.

The polo team had hoped to get a compound similar to a name-brand
supplement known as Biodyl. The supplement is used around the world
but hasn't been approved by the Food and Drug Administration [FDA] in
the US.

Veterinarians often turn to compounding pharmacies like Franck's for
medications that can't be found on shelves, but the dispensaries
generally can only recreate unapproved drugs in limited
circumstances, such as for health reasons.

The FDA and state authorities are investigating.

Biodyl is a supplement made in France by Duluth, Georgia-based animal
pharmaceutical firm Merial Ltd. It wasn't clear how close Franck's
mixture came to the name-brand drug. Lechuza said what they ordered
was supposed to contain vitamin B, potassium, magnesium, and selenium.

The injections provided by Franck's were given to the horses just
hours before their deaths.

Dr Murl Bailey, a toxicology professor at Texas A&M University's
College of Veterinary Medicine & Biomedical Sciences, said selenium
is a common mineral needed in small doses by humans and animals for
growth and tissue stabilization. It can also help muscles recover
from fatigue.

"It's a naturally occurring mineral in the Earth's crust," Bailey
said. But he said it was generally not needed as a supplement since
most people and animals get it in their food.

Bailey said an overdose of selenium can cause the veins in the body
to dilate, "so there's really no blood coming back to the heart."

"The horses go into shock," he said. Necropsies previously revealed
bleeding in the horses' lungs.

Dr Tam Garland, a toxicologist at the Texas Veterinary Medical
Diagnostic Laboratory, said the horses' deaths would likely have been
painful, and irreversible after the overdose. "Hemorrhaging in the
lungs tells me these horses couldn't breathe," Garland said.

[Byline: Brian Skoloff]

--
Communicated by:
Sara M Volk, PhD
Department of Pathology
Center for Biodefense and Emerging Infectious Diseases

University of Texas Medical Branch
Galveston, Texas
USA


******
[2]
Date: Thu 23 Apr 2009
Source: Fox News.com, Associated Press (AP) report [edited]



A Florida pharmacy said Thursday [23 Apr 2009] that it incorrectly
prepared a supplement given to 21 polo horses that died over the
weekend [19 Apr 2009] while preparing to play in a championship match.

Unable to legally bring a supplement into the US to make their horses
more resilient, a Venezuelan polo team had the pharmacy mix up the
concoction. What happened next, though, was disastrous. The chemicals
were mixed wrong, and the 21 horses given the brew died in rapid
succession, some collapsing just before taking the field in a
championship polo match. The others fell soon after, one by one,
shocking a well-heeled crowd gathered to watch the US Open at the
International Polo Club Palm Beach in Wellington.

The Lechuza polo team had hoped to get a compound similar to a
name-brand supplement used safely around the world to help horses
with exhaustion but hasn't been approved by the Food and Drug
Administration. Veterinarians commonly turn to compounding pharmacies
for medications that can't be found on shelves, but the dispensaries
can only recreate unapproved drugs in limited circumstances.

A Florida pharmacy that mixed the medication said Thursday [23 Apr
2009] an internal review found "the strength of an ingredient in the
medication was incorrect." Jennifer Beckett, chief operating officer
for Franck's Pharmacy in Ocala, Florida, would not say whether the
incorrect amount was specified in the order that came from a Florida
veterinarian.

Lechuza said the order was for a compound similar to Biodyl, a
supplement that includes vitamins and minerals. The team has been
using the supplement for many years without problems, but typically
uses the manufactured version instead of going to compounding
pharmacies.

"Only horses treated with the compound became sick and died within 3
hours of treatment," Lechuza said in a statement. "Other horses that
were not treated remain healthy and normal."

While Biodyl isn't approved in the US, the supplement made in France
by Duluth, Georgia-based animal pharmaceutical firm Merial Ltd. is
widely used abroad. The president of the Argentinean Equine
Veterinarian Association, Fernando Ruiz, said the supplement is
commonly used on horses that compete there, and he's not aware of any
deaths.

It wasn't clear how closely Franck's mixture came to the name-brand
drug, though. Lechuza said what they ordered was supposed to contain
vitamin B, potassium, magnesium, and selenium, a mineral that can be
toxic in high doses.

Compound pharmacies can, among other things, add flavor, make
substances into a powder or liquid or remove a certain compound that
may have an adverse reaction in different animal species.

FDA spokeswoman Siobhan DeLancey said the agency's interest is now
"heightened" with news the deaths could have been caused by a medical
mistake at a pharmacy -- one that not only produces drugs for
animals, but also people.

Florida's State Department of Agriculture and Consumer Services and
the Palm Beach County Sheriff's Office are also investigating the
deaths, and the pharmacy and polo team said they're cooperating. The
state agriculture department wouldn't comment on the latest news, but
said testing for chemicals in the horses' blood and tissue continued.
They hoped to have some results by Friday [24 Apr 2009]. Necropsies
of the 21 horses found internal bleeding, some in the lungs, but
offered no definitive clues to the cause of death.

On its website, the FDA says it generally defers to state authorities
to regulate compounding of drugs by veterinarians and pharmacists but
would "seriously consider enforcement action" if one of the
pharmacies breaks federal law. It isn't yet clear Franck's broke the
law. The pharmacy has had no complaints lodged against it, according
to the Florida Department of Health.

A veterinarian not involved in the case said the laws pertaining to
compounding are unclear, and there is little oversight. "It's
confusing to all of us," said Miami veterinarian Zachary Franklin.
"We're not lawyers, we're veterinarians. Almost no one follows the
exact letter of the law," he added.

Franklin said veterinarians often turn to compounding pharmacies to
recreate drugs such as antibiotics, but it is much less common to
compound vitamin and mineral supplements, because the ingredients are
usually readily available. "I don't know what it is about this Biodyl
that they like so much," Franklin said. "There probably is no good
scientific reason to do that."

While polo's US governing body doesn't test horses for drugs,
officials in horse racing wouldn't bother checking for the
ingredients of Biodyl, said the head of a group that helps develop
policies for regulating the racing industry. "There's nothing in it
that would be worth testing for in terms of performance," said Scot
Waterman, the executive director of the Racing Medication and Testing
Consortium. "It's B vitamins and a mineral."

He said there's some concern in his industry about compounding
pharmacies, which can be difficult to monitor. "There are FDA rules
on what can and cannot be compounded but there is little oversight,"
Waterman said. "They play a very important role for the equine
practitioner but there is also potentially a dark side to the
compounders."

--
Communicated by:
ProMED-MBDS


[Selenium is an essential nutrient in horses. However an IV overdose
has disastrous consequences. The consequences of this may be more far
reaching as the FDA has taken an interest in the compounder.

Compounding pharmacies are extremely important in veterinary medicine
as there are many useful and needed medications that pharmaceutical
companies have deemed not profitable enough to manufacture. - Mod.TG]

[Wellington can be located on the HealthMap/ProMED-mail interactive
map of Florida at
. - CopyEd.MJ]

[see also:
Undiagnosed poisoning, equine - USA (04): (FL) 20090423.1533
Undiagnosed poisoning, equine - USA (03): (FL) 20090422.1520
Undiagnosed poisoning, equine - USA (02): (FL) 20090422.1512
Undiagnosed poisoning, equine - USA (FL) 20090420.1494]
...................................tg/mj/lm

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