NEWS - Public Citizen petitions FDA to ban Darvon products

[Guest guest]

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.

http://www.citizen.org/pressroom/release.cfm?ID=2145

Not an MD

I'll tell you where to go!

Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org

[Guest guest]

Gosh, I hope they don't ban it! That's the only way I get any relief!

>

> 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.

>

> http://www.citizen.org/pressroom/release.cfm?ID=2145

>

>

>

>

> Not an MD

>

> I'll tell you where to go!

>

> Mayo Clinic in Rochester

> http://www.mayoclinic.org/rochester

>

> s Hopkins Medicine

> http://www.hopkinsmedicine.org

>

[Guest guest]

Oh goodness...they would have to ban all pain killers. I can't take it as it

makes me hallucinate.

Shandi