Key Events Involving Safety of Vioxx

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Fri, 21 Apr 2006 20:15:22 -0400

[sSRI-Research] Key Events Involving Safety [DANGER] of Vioxx

[will they ever get to the SSRIs????]

 

 

 

 

Key Events Involving Safety of Vioxx

By The Associated PressFri Apr 21, 3:46 PM ET

 

http://news./s/ap/20060421/ap_on_bi_ge/vioxx_timeline_2

 

Key events involving the safety of Vioxx and other painkillers:

 

_May 1999: FDA approves Merck & Co.'s Vioxx, a Cox-2 inhibitor, for

treatment of arthritis and acute pain in adults.

 

_June 2000: Merck gives FDA results of VIGOR study, which shows

Vioxx users suffered five times as many heart attacks as users of the

older painkiller naproxen, sold under the brand name Aleve. Merck

attributes the disparity to naproxen's cardioprotective qualities

rather than a defect in Vioxx, but was rebuked by the FDA for making

that assertion without scientific proof.

 

_September 2001: Merck receives a warning letter from the FDA about

the company's post-VIGOR Vioxx promotional campaign " that minimizes

the potentially serious cardiovascular findings " and " misrepresents

the safety profile of Vioxx. "

 

_April 2002: FDA changes warning label on Vioxx to reflect VIGOR

study results showing increased risk of heart attacks and strokes.

 

_May 2002: Carol Ernst sues Merck, alleging Vioxx triggered the May

2001 death of her husband, Robert Ernst, a 59-year-old Wal-Mart

produce manager who ran marathons.

 

_September 2004: Merck voluntarily withdraws Vioxx from the market

after halting a long-term study that it said showed Vioxx could double

risk of heart attack or stroke if taken for 18 months or longer. The

study, called APPROVe, had focused on whether Vioxx could prevent

reoccurrence of colon polyps, and on cardiovascular effects.

 

_February 2005: FDA panel concludes Vioxx and other similar drugs

all pose heart risks, but should be available to consumers.

 

_Aug. 19, 2005: Texas jury finds Merck liable for the death of

Robert Ernst, awarding his widow $253.4 million in damages. That will

be reduced to about $26 million under Texas caps on punitive damages;

Merck plans to appeal.

 

_Nov. 3, 2005: Atlantic County Superior Court jury rules Merck was

not responsible for a heart attack suffered by Boise, Idaho, postal

worker Federick " Mike " Humeston, who had taken Vioxx for about two months.

 

_Nov. 28, 2005: Squeezed by Vioxx lawsuits, tumbling revenues and

other troubles, Merck announces it will eliminate 7,000 jobs and five

production plants and revamp manufacturing in the first phase of an

anticipated global reorganization.

 

_Jan. 24, 2006: Trial begins in Rio Grande City, Texas, for Leonel

Garza, a 71-year-old who died after taking Vioxx for less than a

month. Garza had suffered from heart disease for 23 years.

 

_Feb. 17, 2006: In the first federal Vioxx case to go to trial,

jurors in New Orleans cleared Merck in the death of Richard " Dicky "

Irvin, who died after taking Vioxx for about a month. The verdict came

on retrial after a federal judge in Houston three months earlier

declared a mistrial when a jury failed to reach a verdict in the case.

 

_April 11, 2006: A jury in Atlantic City, N.J., split in a

two-plaintiff trial, awarding damages to 77-year-old John McDarby, who

suffered a heart attack after taking Vioxx, but absolved Merck in the

case of 60-year-old Thomas Cona.

 

_April 20, 2006: Closing arguments in the Garza lawsuit.

 

_April 21, 2006: Texas jury finds Merck liable in Garza's death and

orders the company to pay $32 million. The case was the sixth of

11,500 lawsuits to reach a verdict. It brings Merck's scorecard [AND

HOW MANY DEATHS???? HOW MANY LIVES AND FAMILIES DESTROYED????] in the

trials to three wins, three losses.

 

 

2006 The Associated Press. All rights reserved. The

information contained in the AP News report may not be published,

broadcast, rewritten or redistributed without the prior written

authority of The Associated Press.

 

 

 

 

2006 Inc. All rights reserved.

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