July/August 2010 - Dogs Naturally Magazine

y: Chris Adams
Staff Reporter The Wall Street Journal
With the aid of slick commercials featuring once-lame dogs
bounding happily about, Rimadyl changed the way veterinarians
treated dogs. ""Clients would walk in and say, 'What about this
Rimadyl?' "" says George Siemering, who practices in Springfield,
VA.
Today, those TV spots are gone. The reason has to do with dogs
like Montana. A six-year-old Siberian husky with stiff back legs,
Montana hobbled out of a vet's office in Brooklyn, N.Y., six
months ago accompanied by his human, Angela Giglio, and a
supply of Rimadyl pills. At first, the drug appeared to work. But
then Montana lost his appetite. He went limp, wobbling instead
of walking. Finally he didn't walk at all. He ate leaves, vomited,
had seizures and, eventually, was put to sleep. An autopsy showed
the sort of liver damage associated with a bad drug reaction.
Pet drugs are big business -- an estimated $3 billion world-wide --
and Rimadyl is one of the bestsellers. It has been given to more
than four million dogs in the U.S. and more abroad, brought
Pfizer Inc. tens of millions of dollars in sales, and pleased many
veterinarians and dog owners. But the drug has also stirred a controversy,
with other pet owners complaining that nobody warned
them of its risks.
Montana's owner, Ms. Giglio, is among them. After she informed
Pfizer and the Food and Drug Administration of her relatively
youthful dog's death, Pfizer offered her $440 ""as a gesture of
good will"" and to cover part of the medical costs. Insulted by the
offer and a stipulation that she agree to tell no one about the payment
except her tax preparer, she refused to sign and didn't take
the money. ""There's just no way in my conscience or heart I can
release them from blame,"" she says.
After reports of bad reactions and deaths started streaming in to
the FDA, the agency suggested that Pfizer mention ""death"" as a
possible side effect in a warning letter to vets, on labels and in TV
ads. Pfizer eventually did use the word with vets and on labels,
but when given an ultimatum about the commercials -- mention
""death"" in the audio or end the ads -- Pfizer chose to drop
them.
Pfizer's director of animal-products technical services, Edward W.
Kanara, says that when reports started coming in, ""we acted extremely
promptly based on the information we had."" Pfizer
points out that reported adverse events involve less than 1% of
treated dogs.
Since Rimadyl's 1997 launch, the FDA has received reports of
about 1,000 dogs that died or were put to sleep and 7,000 more
that had bad reactions after taking the drug, records and official
estimates indicate. The FDA says such events are significantly
underreported.
While the numbers include cases ""possibly"" related to Rimadyl,
it is hard to be sure. Many dogs given the arthritis drug
are older, and few are autopsied after they die. Pfizer says it analyzed
cases of Rimadyl treated dogs that died in 1998 and found
a link to Rimadyl to be ""likely"" in 12% of cases and ""not
likely"" in 22%; it says there was too little information for a
judgment about the others.
Still Approved
Despite these problems, the FDA says Rimadyl deserves to be
on the market, provided vets take the proper precautions. These
include advising dog owners what bad reactions to watch for
and periodically doing liver-function or other lab tests.
Within a few weeks, Pfizer will begin affixing a safety sheet directly
to packages of Rimadyl pills. It is the first time either FDA
officials or Pfizer can recall such a step being taken in the world
of animal drugs.
Dogs...Naturally! July/August 2010