Pet drugs are subject of safety fears

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.


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Posted: 03/10/2007 at 11:50 AM
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Posted: 03/10/2007 at 11:50 AM
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