Lessons Learned From Vioxx, the Ninth Drug Pulled Off the Market Long After Public Citizen Warned Consumers Not to Use
Oct. 22, 2004
Lessons Learned From Vioxx, the Ninth Drug Pulled Off the Market Long After Public Citizen Warned Consumers Not to Use
Worstpills.org Readers Can Get Life-Saving Warnings About Dangerous Drugs Before They Are Removed From the Market
WASHINGTON, D.C. – The Sept. 30 withdrawal of Vioxx from the market was no surprise to Public Citizen or readers of the organization’s Worst Pills, Best Pills newsletter; Public Citizen warned consumers in 2001 not to take the drug because of adverse effects and evidence of a higher risk of heart attack among users.
Vioxx is the ninth prescription drug to be taken off the market in the past seven years that Public Citizen warned Worst Pills subscribers not to use (see chart below). In some cases, Public Citizen listed the drugs as “do not use” drugs months or years before they were pulled from the market due to safety concerns.
The average time between Public Citizen’s warning and a drug’s removal from the market was one year and eight months. For four of the drugs – Vioxx, Baycol, Rezulin and Serzone – Public Citizen issued warnings more than two years before their removal from the market.
Worst Pills, Best Pillsis a monthly newsletter available electronically through Public Citizen’s Web site, www.worstpills.org. The site also has searchable information about the uses, risks and adverse effects associated with prescription medications.
There are 100,000 deaths a year in the United States from adverse drug reactions, and nearly 1.5 million people are injured so seriously by adverse drug reactions that they require hospitalization.
“Worst Pills is an unbiased analysis of data from the Food and Drug Administration (FDA) and other sources, including well-regarded medical journals, that allow us to sound the alarm to consumers long before they are warned by the federal government,” said Sidney Wolfe, M.D., director and founder of Public Citizen’s Health Research Group and co-author of Worst Pills.
Wolfe faults both the FDA and Merck, the maker of Vioxx, for the drug’s long tenure on the market.
“The fact that Vioxx can cause heart damage has been known for years, but the FDA continually ignored warnings about it,” Wolfe said.
The failure of the FDA and the massive promotional campaigns by Merck, which minimized the potentially serious cardiovascular risks, played a role in misrepresenting the safety of Vioxx to the public, Wolfe said.
Vioxx, Celebrex and Bextra belong to the same class of medications known as COX-2 inhibitors, which are touted as anti-inflammatory agents that cause less gastrointestinal damage than the older standby drugs like aspirin or ibuprofen. But both Celebrex and Bextra are also listed on the Worst Pills “do not use” list due to increased cardiovascular risk associated with them.
“This family of drugs, the COX-2 inhibitors, once referred to as ‘super aspirins,’ are turning out to be more like super disasters,” Wolfe said. “We urge people to listen to us about the dangers of these and other drugs. We have a proven track record in predicting the fate of the drugs we warn consumers about.”
The following is a list of nine drugs that Public Citizen warned consumers not to use. All were withdrawn from the market because of multiple injuries and deaths associated with their use.
| Generic Name | Date Withdrawn from U.S. | Worstpills.org Do Not Use |
| Rofecoxib (VIOXX) | September 2004 | April 2001 |
| Nefazodone (SERZONE) | May 2004 | February 2002 |
| Cerivastatin (BAYCOL) | August 2001 | March 1998 |
| Alosetron (LOTRONEX) | November 2000 | August 2000 |
| Cisapride (PROPULSID) | March 2000 | August 1998 |
| Troglitazone (REZULIN) | March 2000 | January 1998 |
| Grepafloxacin (RAXAR) | October 1999 | April 1998 |
| Bromfenac (DURACT) | June 1998 | December 1997 |
| Dexfenfluramine(REDUX) | September 1997 | July 1996 |
Other big-selling drugs still on the market, but listed as “do not use” on worstpills.org include: Crestor, Darvon, Yasmin, Ultracet and Lamisil.
Citizens can subscribe to www.worstpills.org for a $15 fee, which includes a monthly newsletter with additional electronic updates and news on dangerous prescription drugs.
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