Tuesday, December 13, 2005

Chronology - Key events in the history of Merck's Vioxx

CHRONOLOGY-Key events in the history of Merck's Vioxx
A timeline of Vioxx's history follows:
*Nov. 1998 - Merck files an application with the FDA seeking U.S. approval of Vioxx.
Jan. 1999 - Vioxx Gastrointestinal Outcomes Research (VIGOR) trial begins, aiming to show whether Vioxx causes fewer ulcers and other gastrointestinal problems than the standard arthritis treatment naproxen.
*Feb. 1999 - Merck begins first clinical trial of Vioxx to see whether it can treat Alzheimer's disease. A second trial begins in April 2000.
May 20, 1999 - FDA approves Vioxx for the relief of osteoarthritis symptoms, management of acute pain and primary dysmenorrhea, or painful menstruation.
March 2000 - Merck unveils data from Alzheimer's trials, which it said showed no difference in heart problems between patients on Vioxx and others taking a placebo.
June 2000 - Merck submits to the FDA final data from the VIGOR study, which it said showed a decrease in gastrointestinal problems but a four-fold higher risk of heart attacks compared with naproxen.
Feb. 2001 - FDA Arthritis Advisory Committee meets to discuss the gastrointestinal VIGOR study.
April 11, 2002 - FDA approves changes to Vioxx label which include cardiovascular risks, gastrointestinal benefits and a new use to treat rheumatoid arthritis.
Sept. 27, 2004 - Merck tells the FDA a study to see if Vioxx could prevent colon polyps showed twice the risk of heart attacks among patients taking Vioxx for 18 months as those who took placebos.
Sept. 28, 2004 - FDA officials meet with Merck, which tells the agency it will voluntarily withdraw Vioxx. Two days later Merck announces the withdrawal.
Nov. 18, 2004 - Congress holds hearing on Merck and the FDA's handling of the drug's safety issues.
Aug. 19, 2005 - Merck is found negligent in the marketing and design of Vioxx and is ordered to pay $229 million in punitive damages and $24 million for mental anguish and loss of companionship to the widow of a Texas man.
The total award is expected to be cut to about $26 million because of Texas laws limiting damages.
Nov. 3, 2005 - Merck is exonerated in a New Jersey lawsuit involving a man who suffered a heart attack after taking Vioxx but survived. The case was the first tried of thousands of cases filed against Merck in the state.
Dec. 8, 2005 - The New England Journal of Medicine says Merck deleted dangers linked to Vioxx, including three heart attack deaths among users, in its analysis of the VIGOR study.
Dec. 12, 2005 - A U.S. judge declares a mistrial in the first federal lawsuit after a jury fails to reach a unanimous verdict in a case brought by the widow of a Florida man. The case is expected to be retried in 2006.
Source: FDA--