1998:
- Clinical Trials of Vioxx reveal "no CV signals". However, there were concerns regarding "pro-thrombotic effects in vitro" from: FDA Report entitled "Drug Regulation in Controversy: Vioxx" November 10, 2004
- Study "090" conducted by Merck reveals serious cardiovascular problems as compared to patients not taking Vioxx. This study was never published; Merck insisted that it was not large enough to provide definitive data.
1999:
- The FDA approves Vioxx.
- Vioxx enters the market, now the second NSAID. (Celebrex was the first.)
- Merck initiates VIGOR, a study to measure the effects on the stomach in comparision with other pain relieving medications. However, VIGOR revealed "an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared to patients taking naproxen" - FDA News Release - September 2004
2000:
- The VIGOR study concludes. It was published in the New England Journal of Medicine.
- Some experts believe that based on evidence provided by Study "090" and VIGOR combined, there is a strong possibility that VIOXX is an unsafe drug.
2001:
- The FDA recommends label warnings on Vioxx to Merck. It also warns Merck to stop misleading doctors regarding the CV side effects of the drug.
- The FDA and Merck hold ongoing discussions about label changes for Vioxx.
2002:
- As a result of the VIGOR study, the "FDA implemented labeling changes to reflect the findings from the ... study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke." - FDA News Release September 30, 2004
2003 - The Year of the Vioxx:
- Vioxx sales reach $2.5 billion. Vioxx is sold in 80 countries.
2004 - Vioxx Withdrawn:
- September 30 - Vioxx is withdrawn from the market.
- The Vioxx withdraw stimulates concerns and critical questions about other Cox-2 inhibitor drugs Bextra and Celebrex.
- FDA Health Advisory regarding pain relieving drugs is issued.
- FDA orders bold-faced warnings on Bextra labels, according to The Web MD.
2005 - Relabeling and Recalls Abound:
- February - A federal inquiry of Cox-2 inhibitors is opened by the FDA. According to Web MD, the panel recommended Vioxx return to the market, and that Celebrex and Bextra be allowed to stay, provided packages be labeled strictly as to potential CV side attacks. This is submitted to the FDA, who generally heeds these types of recommentations.
- More studies are done, revealing evidence to back concerns.
- Bextra is pulled off the market. Maker Pfizer plans to reintroduce it later.
2005 - 2006 Vioxx Lawsuits and Follow Up Studies for all Cox -2 Inhibitors.:
- The first Vioxx lawsuit is settled in favor of the plantiff.
- The awareness of the increased cardiovascular risk associated with Vioxx and Bextra has many people wondering if all drugs in the Cox-2 inhibitor class, i.e., those still on the market, will increase the possibility of heart disease in takers. Two studies, published in The Journal of the American Medical Society in 2006, lend insight into this issue.
Coverage of the First Vioxx Lawsuit:
About's Arthritis editor, Carol Eustice, has written and very thorough and provocative article on the first Vioxx trial and decision.
Also, USA Today did a special on chronic pain. It is a good source of general information about this serious public health problem.
Also, USA Today did a special on chronic pain. It is a good source of general information about this serious public health problem.
