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December 18, 2004 - BRIAN Caddie still talks about his wife Judy in the present tense. Although he's lived without her smile, bubbly personality and enthusiasm for life for almost five months, he still can't believe she's gone. Mrs Caddie, 63, died of a major heart attack about 12.30am on July 24.

Woken by arthritic pain, she was watching TV in the lounge room of their home at Pomona on the Sunshine Coast. That's where Mr Caddie found her. About three months later, international pharmaceutical company Merck Sharp & Dohme launched a voluntary international recall of their popular anti-inflammatory drug Vioxx and advised all patients to stop using it immediately.

A three-year American trial had found patients who took Vioxx 25mg for 18 months or more had an increased risk of cardiovascular complaints. The risk was reportedly 3.5 per cent in the Vioxx group, compared with 1.9 per cent in the control group. Mrs Caddie had been taking Vioxx for about 15 months and Mr Caddie was one of the first people to join a class action against the company, mounted by Brisbane firm Shine Roche McGowan. Mr Caddie, 68, a retired builder, said there was no doubt in his mind Vioxx was responsible for the death of his wife of 13 years, who was a mother of four and grandmother of nine, and who enjoyed a close relationship with his own two children and sole grandchild.

In the days before her death she underwent a battery of tests with her specialist, including cardiographs and 24-hour heart monitoring, as part of a regular check-up. "Every one was negative," Mr Caddie said of the tests. "The day before she died we were out having such a great time. We went to the doctor's in the morning, she bought some new clothes and her favourite perfume, we played the poker machines for a few hours and then we drove home and had a lovely curry dinner, which she is extremely good at.

"Judy could make a party for two people or 50 people with no trouble whatsoever. Then she disappeared." More than 350 people have joined the Shine Roche McGowan suit, the first in Australia lodged against the company – known here as MSD Australia – over the issue. Among them is Trish Hunsley, 45, who suffered a heart attack on September 6 last year. She and her husband Gordon had driven to a friend's home to celebrate a christening. The families had just finished dinner and were chatting when Mrs Hunsley started to feel unwell, hot and clammy. "I thought it could have been the chicken sandwich I had at the service station on the way down," she said. "I thought 'great, food poisoning' and went to lay down on the bed," she said. "Then the chest pain just hit me. It was massive."

She was rushed to hospital with a major heart attack that damaged 40 per cent of the vital organ. She had an angiogram and stent inserted, then a few months later returned to hospital to have a defibrillator fitted. With no family history or other medical indicators, doctors told her she had had an "unexplained" heart attack. The fact she had been taking Vioxx for arthritis in her back since 2001 wasn't questioned until the drug was recalled. For the mother of two, the fight against Merck Sharp and Dohme is more about protecting other families and ensuring all drugs released on the Australian market are safe.

Shine Roche McGowan partner Roger Singh said inquiries were coming "thick and fast" from people who had taken Vioxx and experienced an adverse effect, or those who believed a loved one's death was linked to it. The civil claim – which Mr Singh said could reach the multimillions – was lodged in the NSW Supreme Court early this month, and a directions hearing on Tuesday was adjourned until February to allow MSD Australia's legal team time to receive directions from the American parent company.

At least another two southern personal injury law firms are reportedly investigating legal action against the company. In the US, about 300 lawsuits are pending. An MSD Australia spokeswoman said she could not comment on the class actions because they were before the courts, but said all legal proceedings would be actively defended. Vioxx, the trade name for rofecoxib, is an anti-inflammatory drug that, according to company information, belongs to a group of medicines called Coxibs or Cox-2 inhibitors, and works by blocking production of certain substances that cause pain and inflammation.

Since 1999 it has been marketed in 80 countries after being listed by the Therapeutic Goods Administration that year to treat osteoarthritis and rheumatoid arthritis at a dose of 25mg. About 3.2 million prescriptions for the drug were filled last year, with about 300,000 Australians reported to be taking it – making it Australia's second most popular anti-inflammatory drug and one of the top 50 most used. Product information warns against taking Vioxx by people allergic to ingredients, with active stomach or intestinal ulcers or bleeding, breastfeeding or planning to breastfeed, or history of asthma, rash, runny nose or other allergic reactions after taking other anti-inflammatory medicines.

There is no mention of heart conditions, although the TGA alerted doctors to evidence of increased risk of heart conditions related to doses higher than 25mg in October last year. Since the recent recall the TGA's Adverse Drug Reactions Advisory Committee has urged doctors to reconsider the use of all Cox-2 inhibitors or anti-inflammatory drugs until a national safety review is finalised. The committee's bulletin recommends that "it would be wise to consider each of them, including celecoxib (Celebrex), may confer an increased risk of cardiovascular events".

The MSD Australia spokeswoman said Merck Sharp & Dohme was committed to patient safety and rigorous adherence to scientific investigation. "On the 23rd September 2004, the APPROVe trial showed, for the first time, that there was an increased risk of confirmed cardiovascular events beginning after 18 months of treatment in patients taking Vioxx compared to those taking placebo," she said.

"Within one week of learning of these results, Merck Sharp & Dohme acted in what it believed was the best interests of patients and voluntarily withdrew Vioxx from the market. We are confident that a careful and complete examination of Merck Sharp & Dohme's conduct will show that, at all times, the company acted responsibly and appropriately regarding the availability of Vioxx in Australia," she said.

• Information about the recall can be obtained from the Merck Sharp & Dohme information line on 1800 066 426. Information about the class action can be found at www.vioxxlegal.com.au or by phoning 13 11 99.

The Courier-Mail

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