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 It was withdrawn gradually rather than immediately because the narcotic has addictive properties and patients require adequate time to switch to other painkillers.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. since 1981.

Drug unsafe, unimpressive painkiller
Multiple 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
Patients taking 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.

FDA Advisory Committee: "Darvon should be banned!" -- E-alert from WorstPills.org

Dear Kate,

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 the market.

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 its benefits.

How much more evidence does the agency need? We again urge the FDA to do the right thing and ban this drug.

Read more about the Darvon decision at www.WorstPills.org

Sincerely,

Dr. Sidney Wolfe
Director, Health Research Group
Public Citizen

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

http://www.fiercepharma.com/story/fda-experts-consider-darvon-ban/2009-01-30?utm_medium=nl&utm_source=internal&cmp-id=EMC-NL-FP&dest=FP

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 2007.

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 the drug.

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 effects."

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."