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Vioxx Debate Echoed in Battle Over Dog Drugs

 

Friday, May 12, 2006

The drug came on the market four years ago after being

tested in a healthy, young population, although it was

intended for use by the old and sick. The manufacturer

aggressively advertised it and ultimately made claims

deemed by regulators to be beyond what testing had

established.

When reports of illness and death linked to the drug

surfaced not long after it went on the market, the

company was slow to report the problems to the Food

and Drug Administration. The agency eventually did

issue a reprimand and a formal warning letter, but two

years later the drug is still being sold, and some

consumers complain that too little is being done to

warn pet owners of its dangers.

 

The medication is Deramaxx, and it's the center of

another drug controversy. But this medication isn't

for people. It's for dogs.

An anti-inflammatory closely related to the human

painkiller Vioxx, which was taken off the market in

2004 and is now the subject of thousands of lawsuits

against Merck & Co., Deramaxx has helped relieve many

canine aches and pains. But in an echo of the national

debate over the dangerous side effects of some popular

human drugs, Deramaxx has also proved at times to be

deadly.

Before the early 1990s, most drugs given to pets were

human medications that appeared to help animals as

well. But with dogs in particular living longer and

being treated increasingly as members of the family,

the demand for better drugs has grown, along with the

public's willingness to pay for them. Most companies

that now develop and sell pet drugs are subsidiaries

or divisions of the major brand-name drug companies,

and they must seek FDA approval to market their

products much as they do with drugs intended for

people.

Deramaxx is not the only drug to run into trouble in

the burgeoning world of animal medicine. The widely

used ProHeart 6 heartworm treatment was the subject of

controversy several years ago and was withdrawn from

the market in 2004 following reports that healthy dogs

were becoming sick and dying after getting a shot of

the preventive medicine.

In both cases, the deadly side effects led to formal

-- but by many accounts ineffective -- government and

industry efforts to warn veterinarians and dog owners

of the drugs' risks.

In 1999, 300 pet owners filed a lawsuit against Pfizer

Inc., alleging that its early dog arthritis medicine

Rimadyl had seriously harmed their pets. Pfizer

settled in 2003, saying it had done nothing wrong but

wanted to avoid costly litigation. Each plaintiff was

given $1,000.

The ProHeart 6 case also led to allegations that its

manufacturer, Wyeth, had sought to discredit the FDA

official overseeing the investigation -- a pattern

seen with FDA officials who questioned the safety of

human drugs.

Victoria Hampshire, the agency official at the center

of the ProHeart 6 controversy, was taken off the case

and later became a whistle-blower. Her difficulties

were documented on the Senate floor last winter by

Sen. Charles E. Grassley (R-Iowa). Wyeth maintains

that it simply gave the FDA potentially troubling

information it found on a Web site about a possible

conflict of interest involving Hampshire. The agency

cleared her after an investigation, and ProHeart 6

remains off the market.

Hampshire says she became increasingly alarmed after

receiving reports of hundreds of dogs dying soon after

receiving the heartworm shots, just as more than 350

reports of deaths linked to Deramaxx have come into

the FDA's Center for Veterinary Medicine. As with

adverse reactions in people, the number of reported

cases is generally believed to represent less than 10

percent of the true total.

 

 

 

 

 

 

 

 

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Merk was fined US$ 50,000 ot be paid to a man who died after taking Viox for a period less than one month and died of a heart attack. Several cases are pedning against Merk in this matter

On 5/13/06, james white <kennelled wrote:

 

 

Vioxx Debate Echoed in Battle Over Dog Drugs Friday, May 12, 2006The drug came on the market four years ago after beingtested in a healthy, young population, although it wasintended for use by the old and sick. The manufacturer

aggressively advertised it and ultimately made claimsdeemed by regulators to be beyond what testing hadestablished

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