Healthfully.org has posted several article warning about
acetaminophen—doesn’t work and in high doses causes liver damage. Propoxyphene is similar to codeine, which is about 1/5th the strength
of morphine. The problem is that when there is severe most people will double
our triple the dose—at this level the acetaminophen can cause liver damage—300-400 annually in GB were dieing. There is no advantage to adding acetaminophen, which is little better than a
placebo. A number of medications
have acetaminophen added. Ask your doctor for a different formulation,
such as Davon Compound. I tell my
doctor that acetaminophen doesn’t agree with me and ask an opiate with aspirin, which increases the analgesic effect. Since I don’t drink caffeinated beverages, I also ask for a formula without
Darvon, generic name propoxyphene,
Darvon compound generic name Propoxyphene, aspirin, and caffeine, and Darvocet-N (Darvocet) generic name propoxyphene and acetaminophen. Oral equivalence 30 mg of morphine, 130 mg of propoxyphene, 130 of codeine
DARVOCET Now Phased Out of U.K. Market; Still Widely Prescribed in the U.S. Worst Pills Best Pills Newsletter article January, 2008
The beginning of 2008 marks the end of the United Kingdom’s two-year phase-out of the combination
propoxyphene and acetaminophen (DARVOCET), the narcotic painkiller which has been pulled from the U.K.
market due to high numbers of accidental and intentional overdoses and deaths.
In 2005, British health authorities ordered a phased withdrawal of the drug, known in the U.K.
as co-proxamol. It was withdrawn gradually rather than immediately because the narcotic has addictive properties and patients
require adequate time to switch to other painkillers.
Yet the U.S. Food and Drug Administration (FDA) has taken no steps to remove this dangerous drug from
the U.S. market.
Almost two years ago, Public Citizen’s Health Research Group filed a petition with the FDA proposing
a phased withdrawal of all drugs containing propoxyphene as an ingredient from the market. The agency has yet to respond to
our petition, and the drug remains widely prescribed. In 2006, 22 million prescriptions for just the combination of propoxyphene
and acetaminophen were filled in U.S. pharmacies, making it
the 17th most-prescribed generic drug in this country.
According to British health authorities, the drug was banned because “each year there are 300- 400 fatalities following deliberate or accidental
drug overdose involving propoxyphene/acetaminophen in England
and Wales alone. Approximately one-fifth [60-80] of these
deaths are considered to be accidental.” The British government further stated that the drug’s effectiveness “is
poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable.... It has not been
possible to identify any patient group in whom the risk-benefit [ratio] may be positive.” In other words, there is no
group of people for whom the benefits outweigh the risks.
Not surprisingly, the number of accidental deaths in the U.S.
is even higher: more than 2,500 accidental deaths have been reported in association with propoxyphene in the U.S.
Drug unsafe, unimpressive painkiller
controlled clinical trials, the “gold standard” in research on drugs, have shown that propoxyphene is a relatively
weak painkiller. In a study published almost 40 years ago in the Journal of the American Medical Association, propoxyphene
was found to be no more effective than two aspirin tablets.
Further, the drug has dangerous side effects. When propoxyphene is broken down in the body, it is converted
into a compound that is toxic to the heart.
The drug has a very small margin of safety – a dangerous dose is only slightly higher, or may
be no higher than an effective dose. The safety margin can become even more unfavorable to patients taking the drug who have
not experienced relief and thus take more of the drug, accidentally causing heart toxicity.
What You Can Do
a propoxyphene-containing product should consult their physician about switching to a safer, more effective painkiller.
Given that opiate overdose is rare (the combination of opiate with a tranquilizer--most
often alcohol—produces nearly all the supposed opiate-overdose deaths). Acetaminophen
has nearly no therapeutic value and it nevertheless cause more hospitalization and deaths due to liver toxicity than any other prescription or over-the-counter drugs--jk.
Worst Pill 3/1/9/09 at http://www.worstpills.org/member/ealert.cfm?ea_id=54 It has been ban in England.
Advisory Committee: "Darvon should be banned!" -- E-alert from WorstPills.org
Big news from Public Citizen! Thirty years after Public Citizen first petitioned to have it banned,
Food and Drug Administration (FDA) advisory committees voted on Jan. 30th to confirm that the risks of propoxyphene (Darvon)
outweigh its benefits and recommended that the drug be withdrawn from the market. The FDA should, therefore, remove it from
Most advisory committee members did not think there was evidence that the drug has significant benefits.
Without benefit, serious risk of death - which this drug carries - should not be tolerated. In Florida
alone, medical examiners determined that propoxyphene caused the deaths of 85 people in 2007. For 25 of those people, it was
the only drug that caused their deaths. These latest data come atop years of other data showing that the drug's risks outweigh
How much more evidence does the agency need? We again urge the FDA to do the right thing and ban this
Read more about the Darvon decision at www.WorstPills.org
Dr. Sidney Wolfe
Director, Health Research Group
Davron has been banned in England,
why not in the U.S.
FDA experts to consider Darvon ban
FiercePharma, Jan 30. 2009, by Tracy Staton
Another set of pain pills faces possible extinction because of abuse: The FDA is asking
an advisory committee to weigh in on whether to keep Darvon and Darvocet meds on the market.
Darvon (propoxyphene) was originally developed by Eli Lilly and has been on the market
for more than half a century. Darvocet combines Darvon's active ingredient with acetaminophen. Both meds are sold as generics
now, and more than 20 million scrips were written for products containing their API in
So what's the beef? Consumer watchdog Public Citizen petitioned the FDA to get the
products banned, then sued when the agency didn't act. The lawsuit cited data implicating propoxyphene in 5.6 percent of the drug related deaths
from 1981 to 1999. Plus, Public Citizen claims, the products are "relatively weak" painkillers, and they're toxic at only
slightly more than the recommended dosage. U.K. health officials
pulled the products in 2006 because of similar concerns, the Wall Street Journal reports.
FDA says it found 1,452 deaths associated with propoxyphene from 1957 through September
2008, but some of those reports listed more than one drug. Two of the generics makers selling the propoxyphene products--Xanodyne
Pharmaceuticals and Qualitest/Vintage Pharmaceuticals--say they're safe and effective when used as directed, and they pointed
out that more than 600 million scrips for the drugs have been dispensed over the past 50 years
Wall Street Journal | Health section, January 31, 2009, Jennifer dooren & Alica Mundy at http://online.wsj.com/article/SB123326421629330211.html
WASHINGTON -- A Food and Drug Administration
panel recommended banning the painkiller Darvon and a related drug, following a decades-long effort by critics who charged
that the drugs' users often intentionally or unintentionally overdose on them.
Darvon has been on the market since 1957, and Saturday marks the 30th anniversary of
the first congressional hearing on its safety. Nonethless, it still enjoys wide use in treating mild to moderate pain. More
than 20 million prescriptions were written in 2007 for products containing propoxyphene, the active ingredient in Darvon,
according to the FDA.
The panel voted 14-to-12 that the drug's benefits didn't outweigh its risks, and called
for removal from the U.S. market. The final decision is up
to the FDA, which usually adopts panel recommendations but not always, especially when the vote is so close.
Darvon's defenders argue it is safe and effective when used as directed. The label
warns against taking it in combination with alcohol or certain other drugs.
Darvon was developed by Eli Lilly & Co., which later combined propoxyphene with acetaminophen, the active ingredient
in Tylenol, and sold that pill as Darvocet. Today the drugs are marketed by generic-drug makers.
Sidney Wolfe, a doctor at the advocacy group Public Citizen, has been fighting Darvon
since the late 1970s, and triggered Friday's panel meeting with a petition and a lawsuit that sought to force the FDA to ban
In its petition, Public Citizen cited data from the Drug Abuse Warning Network implicating
propoxyphene in 5.6% of drug-related deaths from 1981 to 1999. Public Citizen also said the network reported 2,110 accidental
deaths related to propoxyphene over the same period.
The FDA also cited reports of serious events such as suicides, intentional and unintentional
overdoses and heart attacks. But the agency's analysts said the evidence wasn't conclusive enough to ban Darvon.
In an interview about Darvon before Friday's meeting, Dr. Wolfe said, "Claims of its
efficacy have been seriously undercut by the FDA's own analysis." He noted that the agency said Darvon "possesses weak analgesic
In his presentation Friday, Dr. Wolfe presented updated data showing 503 deaths in
2007 in which propoxyphene was listed as a contributing factor. "All drugs have risks," Dr. Wolfe said. "If they don't have
benefits they need to come off the market."