Drug Mix Blamed for Florida Horse Deaths

WEST PALM BEACH, Fla. (AP) - Unable to legally bring a
supplement into the U.S. to make their horses more resilient, a
Venezuelan polo team used another way to get ready for a champion
match: Have a pharmacy mix up the concoction.

What happened next, though, was disastrous. The chemicals were
mixed wrong, and 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 U.S. 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 that
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, Fla., 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 three 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 U.S., the supplement made in
France by Duluth, Ga.-based animal pharmaceutical firm Merial Ltd.
is widely used abroad. The president of the Agentine 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.

Back on the field at the club, matches resumed for the first
time since the deaths with a moment of silence and a prayer. White,
red and pink carnations were laid on a pond bordering the field
where the horses died.

"It's tragic for the horse world," said Dorothy Hungerford, of
Wrightsville, NC. "This is a shock."

Jimmy Newman, the polo club manager, said the news about the
trouble with the supplement let out a tremendous amount of tension
at the club.

"It's a terrible, terrible thing and it's not going to bring
those 21 horses back," he said. "But at least it's down to a
simple mistake. It's not sabotage and it's not anything that anyone
in polo planned to do."

Meanwhile, 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. Necropsies of the 21 horses found internal bleeding, some
in the lungs, but offered no definitive clues to the cause of
death.

On its Web site, 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 if
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 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 U.S. 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."


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