The FDA issued the following advisory to patients following the announcement by Merck:

The Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.

May 1999
Vioxx is approved by the FDA.

March 2000
Study finds Vioxx patients had double the rate of serious cardiovascular problems compared to those taking naproxen.

February 2001
FDA advisory panel recommends warning label noting possible link to heart attacks and strokes.

September 2001
The FDA warns Merck for misleading claims about the safety of the drug.

April 2002
FDA requests that Merck add a warning on the label about cardiovascular problems.

August 2004
FDA announces results of a study that found Vioxx users were more likely to suffer a heart attack or sudden cardiac death than those taking Celebrex.

September 2004
Merck & Co. withdraws Vioxx.

March 2005
U.S. District Court for the Eastern District of Louisiana begins pretrial proceedings for those people pursuing their Vioxx lawsuit in federal court.

August 2005
Texas jury returns a verdict in favor of family of man who died after taking Vioxx. The jury found Merck negligent in the death of the man.

August 2006
New Orleans jury returns a $51 million verdict in favor of Gerald Barnett. Mr. Barnett, a retired FBI agent, was represented by O'Steen & Harrison and Mark Robinson.

November 2007
Merck announces a global settlement to resolve claims pending in U.S. courts for $4.85 billion.

October 6, 2004—An article appearing the Wall Street Journal reported Vioxx may have led to more than 27,000 heart attacks and cardiac deaths before it was removed from the market. The article cited an unreleased study conducted by the FDA.

The report concluded that as many as 27,785 heart attacks and cardiac deaths could have been prevented had doctors prescribed a competing arthritis drug.

The purpose of the study was to evaluate the effectiveness of Vioxx in preventing colon cancer. The clinical study was halted prematurely when it became apparent to the manufacturer that participants taking Vioxx were at a greater risk of suffering a heart attack or other cardiovascular problems.

Vioxx already had come under scrutinty from medical experts after an article published in JAMA in June 2001 reported that use of Vioxx may cause kidney problems. JAMA reported later that year that a link between Vioxx and cardiovascular problems may exist. Some clinical studies have indicated that Vioxx increased the rates of high blood pressure.

In June 2001, Merck submitted to the FDA a clinical study that reported an increased risk of cardiovascular events, including heart attacks and strokes. As a result of this study, the FDA implemented labeling changes in April 2002 that provided information abou the increase in risk of cardiovascular problems.

In September 2001, the FDA sent a warning letter to Merck & Co. demanding that the company correct "false or misleading impressions" about the safety of Vioxx. In various promotional materials, the company downplayed connections between Vioxx and serious cardiovascular problems, including heart attacks and strokes. The FDA wrote:

You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the Vioxx Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for Vioxx.

In April 2002, the FDA required that Merck & Co. note a possible link to heart attacks and strokes on the label of the drug. An article in The New England Journal of Medicine estimated Merck & Co. continued spending about $100 million per year to promote the defective drug. Merck & Co. consistently disputed scientific findings that Vioxx increased the risk of heart attacks and stroke. These denials compromised the safety of millions of Americans.