: Pet drugs are subject of
safety fears by Jeff Donn
Associated Press Writer
Sun Mar 11, 7:11 AM ET
Authorities and pet owners are beginning to
raise serious questions about the safety and effectiveness of animal
medicines, mirroring worries over human drugs like the painkiller Vioxx.
Tested on just a couple hundred animals,
a drug meant for pets is less apt than a human one to show all its
failings until it reaches market, veterinarians say. More than 700 drugs
have been approved for pets, but many others are used legally without
explicit approval for animals. Most pet drugs were first developed for
people.
But there is deepening awareness that
what works in people may not work in animals. Indeed, each species of
animal — even varying breeds — may react differently to the same drug.
Further, animals can't say if a drug
makes them feel bad. "I can't tell until you see something physical,"
says Laurryn Simpson of Commerce Township, Mich., who founded the Web
site dogsadversereactions.com.
The worries arise at a time when
intensifying demand has pressured the FDA to hire more reviewers and
sort through research more quickly to decide whether to approve new pet
drugs. Given the smaller pet market, many companies save development
costs by relying on cheaper experiments with typically a tenth as many
subjects as in human tests.
Dr. Stephen Sundlof, the vet who directs
the FDA's Center for Veterinary Medicine, says if the agency insisted on
the same size studies as for people, "we would have very few drugs" with
formal approval for pets. But he adds, "The rigor is every bit as great
as with human drugs."
Since the year 2000, reports of side
effects in animal drugs have gone up about 90 percent, to 34,603 last
year, FDA records show. The agency ties the growth to new types of drugs
and greater understanding of potential dangers — not worsening safety.
However, vets say that the vast majority of side effects are never
reported, so it's hard to gauge overall safety.
And many vets barely speak of possible
side effects when they recommend a drug, some clients complain.
Jean Townsend, of Johns Island, S.C.,
says her vet breathed "not one word" of side effects when he prescribed
the painkiller Rimadyl for her arthritic, limping Labrador retriever.
Encouraged by an advertisement showing
dogs romping playfully, Townsend says she was glad to soothe her pet's
aches. Within a month, though, he collapsed and began to vomit blood. A
week later, he had to be put to sleep, his kidneys and liver ravaged
beyond repair, his medical records show.
"The medicine blew him apart," says
Townsend. Her vet and FDA reviewers all blamed the drug, which was
originally targeted for humans.
Without admitting wrongdoing, drug maker
Pfizer paid out roughly $1,000 to each of 300 pet owners, including
Townsend, to settle a lawsuit in 2004.
Rimadyl, taken by more than 10 million
dogs since 1997, is now tied to more than 3,000 pet deaths, FDA data
show. Many of these pets, predominantly dogs, had damaged livers or
kidneys.
Rimadyl is in the same broad NSAID family
of drugs as Vioxx. However, unlike Vioxx, it stayed on the market.
The FDA stresses the need for medicines
like Rimadyl, partly because pets cannot tolerate the range of
pain-killing alternatives that humans can. Dogs are more sensitive to
aspirin than humans. And a single Tylenol can kill a cat.
But sometimes a drug's risk is too great
to accept. A heartworm medicine, Proheart 6, was pulled from the market
in 2004 after FDA researchers found evidence of fatal side effects.