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Key events in the development of Vioxx

A jury Friday found Merck & Co. liable in the death of a Texas man, in the first civil trial against the company’s popular painkiller Vioxx. A timeline of the drug’s history follows.
/ Source: Reuters

A jury Friday found Merck & Co. liable in the death of a Texas man, in the first civil trial against the company’s popular painkiller Vioxx. A timeline of the drug’s history follows:

1998

  • Nov. 1998: Merck files an application with the FDA seeking U.S. approval of Vioxx.

1999

  • Jan. 1999: Vioxx Gastrointestinal Outcomes Research (VIGOR) trial begins, aiming to show whether Vioxx causes fewer ulcers and other gastrointestinal problems than a standard arthritis treatment called naproxen.
  • Feb. 1999: Merck begins first clinical trial of Vioxx to see if 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.

2000

  • 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.

2001

  • Feb. 2001: FDA Arthritis Advisory Committee meets to discuss the gastrointestinal VIGOR study.

2002

  • April 11, 2002: FDA approves changes to Vioxx label which include cardiovascular risks, gastrointestinal benefits and a new use to treat rheumatoid arthritis.

2004

  • 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.

2005

  • 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 the Texas man.