Learn more about our policy experts.

Media Contacts

Angela Bradbery, Director of Communications
w. (202) 588-7741
c. (202) 503-6768
abradbery@citizen.org, Twitter

Barbara Holzer, Broadcast Manager
w. (202) 588-7716
bholzer@citizen.org

Karilyn Gower, Press Officer
w. (202) 588-7779
kgower@citizen.org

Ben Somberg, Press Officer (regulatory matters)
w. (202) 588-7742
bsomberg@citizen.org, Twitter

Other Important Links

Press Release Database
Citizen Vox blog
Texas Vox blog
Consumer Law and Policy blog
Energy Vox blog
Eyes on Trade blog
Facebook/publiccitizen

Follow us on Twitter

 

Feb. 28, 2006

Public Citizen Petitions FDA to Ban Darvon Products

Prescription Painkiller Causes Many Fatalities; Petition Filed Today with FDA

WASHINGTON, D.C. – Public Citizen today petitioned the U.S. Food and Drug Administration (FDA) to immediately begin to phase out the widely prescribed pain reliever propoxyphene (Darvon, Darvocet and generic versions) from the market because the drug has been associated with more than 2,000 accidental deaths, is physically addictive and is no more effective than safer alternatives.

Data from the Federal Drug Abuse Warning Network, which provides autopsy information from medical examiners in the United States, has found that 5.6 percent of all drug-related deaths were related to propoxyphene during the past 19 years. In 2004, 23 million prescriptions for propoxyphene were filled, making it the 12th most commonly prescribed generic drug in the United States. Four companies account for more than 91 percent of U.S. prescriptions.

Propoxyphene has been associated with 2,110 reported accidental deaths in the United States since 1981. A large proportion of these deaths occur because most of the drug is converted into a metabolite that is highly toxic to the heart and lasts longer in the body than the original compound, resulting in cardiac depression. Adverse cardiac events associated with propoxyphene include an interruption of heart transmission of electrical impulses, slowed heartbeats and a decreased ability of the heart to contract properly.

“The number of deaths involving propoxyphene in the U.S. alone is striking,” says the petition, filed by Public Citizen and two Swedish experts on propoxyphene, Drs. Ulf and Birgitta Jonasson. The entire petition can be viewed at www.WorstPills.org.

Last year, the British government announced a phased withdrawal of the drug because of its negligible effectiveness and the high risk of overdose and death. “It has not been possible to identify any patient group in whom the risk-benefit [ratio] may be positive,” the British government stated.

In addition, popoxyphene has been deemed inappropriate for prescription for the elderly because of central nervous system-related adverse events – such as sedation and confusion – that have been found to increase the likelihood of falls and fall-related fractures in the elderly. Studies have shown that propoxyphene use is widespread in the institutionalized population, in emergency rooms and in community-dwelling older people, populations in whom propoxyphene is most dangerous.

Public Citizen is calling for the drug to be phased out, rather than banned immediately, because of its addictive quality.

“The Food the Drug Administration should immediately begin phasing out the use of propoxyphene,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “Millions of people, many of them elderly, are being put at risk when using this drug when there are safer, more effective alternatives available. We agree with the British government’s conclusion that the efficacy of this product ‘is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable.’ ”

Public Citizen has a strong track record of identifying dangerous drugs well before federal regulators take action to ban or put warnings on these drugs. For example, Public Citizen warned consumers about the dangers of Vioxx, ephedra, Bextra, Rezulin, Baycol, Propulsid and many other drugs years before the drugs were pulled from the market. 

###  

Copyright © 2014 Public Citizen. Some rights reserved. Non-commercial use of text and images in which Public Citizen holds the copyright is permitted, with attribution, under the terms and conditions of a Creative Commons License. This Web site is shared by Public Citizen Inc. and Public Citizen Foundation. Learn More about the distinction between these two components of Public Citizen.


Public Citizen, Inc. and Public Citizen Foundation

 

Together, two separate corporate entities called Public Citizen, Inc. and Public Citizen Foundation, Inc., form Public Citizen. Both entities are part of the same overall organization, and this Web site refers to the two organizations collectively as Public Citizen.

Although the work of the two components overlaps, some activities are done by one component and not the other. The primary distinction is with respect to lobbying activity. Public Citizen, Inc., an IRS § 501(c)(4) entity, lobbies Congress to advance Public Citizen’s mission of protecting public health and safety, advancing government transparency, and urging corporate accountability. Public Citizen Foundation, however, is an IRS § 501(c)(3) organization. Accordingly, its ability to engage in lobbying is limited by federal law, but it may receive donations that are tax-deductible by the contributor. Public Citizen Inc. does most of the lobbying activity discussed on the Public Citizen Web site. Public Citizen Foundation performs most of the litigation and education activities discussed on the Web site.

You may make a contribution to Public Citizen, Inc., Public Citizen Foundation, or both. Contributions to both organizations are used to support our public interest work. However, each Public Citizen component will use only the funds contributed directly to it to carry out the activities it conducts as part of Public Citizen’s mission. Only gifts to the Foundation are tax-deductible. Individuals who want to join Public Citizen should make a contribution to Public Citizen, Inc., which will not be tax deductible.

 

To become a member of Public Citizen, click here.
To become a member and make an additional tax-deductible donation to Public Citizen Foundation, click here.