The FDA Finally Banned A Toxic/Useless Drug Called Darvon Six Years After It Was Banned in the U.K.

In July I wrote a post about the drug industry contolled FDA:

This is the part about Darvon, Darvocet or propoxyphene (generic).

On Jan. 30, 2009 an FDA advisory committee voted that Darvon’s (Darvocet is Darvon with Tylenol) risks outweigh it’s benefits and say the drug should be banned and it should be removed from the market. Now, how long did it take them to figure this out? It has been around a long time.

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. http://www.citizen.org/pressroom/release.cfm?ID=2814

Darvocet does almost nothing for pain, it is the Tylenol which mainly works on the pain. Darvon is addicting, but does not work all that well on pain and it causes depression which can result in suicide. All narcotics cause depression. Darvon (generic: propoxyphene) has been associated with over 10,000 deaths and 2,110 reported accidental deaths in the United States. It forms a metabolite that is toxic to the heart. The Journal of the American Medical Association, published a study over 36 years ago in which they found that Darvon or Propoxyphene was no more effective that two aspirin tablets, yet they continued to prescribe it. In 2004 23 million prescriptions were filled. On July 7th of this year the FDA denied a petition from Public Citizen to ban the drug. They have wimped out once again. They basically issued a statement that more research on the effects on the heart be done, warned about excess Tylenol use, and overdose. They did not even address the suicides it has caused from depression. Who got paid off this time?

From Dr. Sydney Wolfe for Public Citizen:

The announcement by the U.S.Food and Drug Administration (FDA) that propoxyphene-containing products are finally going to be taken off the market – because of dangers previously known and acted upon, with bans announced in the UK almost six years ago, and in Europe, almost 1½ years ago – is a serious indictment of the FDA’s long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller. In announcing the ban in 2005, the UK stated that the efficacy of propoxyphene (sold generically and under the brand name Darvon) “is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable” and that “[I]n relation to safety, there is evidence that fatal toxicity may occur with a small multiple of the normal therapeutic dose and a proportion of fatalities are caused by inadvertent overdose.” The FDA’s claim that this is the first evidence that the drug is dangerous at the “standard therapeutic dose” thus rings dangerously hollow.

The FDA’s deadly delay in this case starkly illustrates how one of the most important public health concepts, the precautionary principle, was embraced by the UK and Europe, but was for too long recklessly rejected by the FDA.

Evidence going back more than 30 years indicates that propoxyphene is not very effective, is toxic at doses not much higher than the recommend dose because a heart-toxic metabolite accumulates in the body, and is somewhat addictive (It is actually very addicting). It has been linked to many thousands of U.S. deaths since 1981, a large proportion of which were likely caused by cardiac toxicity, including the interruption of electrical conduction in the heart.

People don't steal prescription pads so they can write their own prescriptions for a somewhat addictive drug.

Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since time the UK ban was announced. The best forensic data, the kind relied upon in those countries for the UK and European bans, come from Florida where, because of routine drug testing required by the state medical examiner as part of many autopsies, deaths are categorized as being “caused” by certain drugs if the levels found are to be above a certain level. From 2005 through 2009, in Florida alone, 395 deaths were “caused” by propoxyphene. If data from 2007 are representative, in that year, 78 percent of the Florida deaths caused by propoxyphene were ruled accidental.

Our February 2006 petition to the FDA to ban the drug, following the UK ban announcement, did not even result in an FDA advisory committee hearing until we had sued the agency in 2008 to force them to respond to our petition. The subsequent January 2009 FDA advisory committee hearing resulted in a 14-12 vote in favor of banning propoxyphene, despite some FDA efforts to sway the committee against voting for a ban. In July 2009, several weeks after the European Medicines Agency announced its ban, the FDA denied our petition to ban the drug.

We have Public Citizen to thank for this. Check out their time line of their fight to get Propoxyphene banned.

From WebMD:

The FDA has at last banned Darvon, Darvocet, and other brand/generic drugs containing propoxyphene -- a safety-plagued painkiller from the 1950s.

New proof of heart side effects, in studies of healthy people taking normal doses of the drug, prompted the FDA to act.

An estimated 10 million Americans are taking Darvocet and other propoxyphene painkillers. They should NOT immediately stop taking the drugs, as there is danger of serious withdrawal symptoms.

Patients taking the drugs should instead immediately contact their doctors for help switching to different methods of pain control.

"Don't delay," warns Gerald Dal Pan, MD, MHS, director of the FDA's office of surveillance and epidemiology.

The FDA action comes nearly six years after the drug was banned in the U.K., and nearly a year and a half after the European drug agency banned it.

The public interest group Public Citizen petitioned the FDA to ban the drug in 1978 and again in 2006. The latter petition caused the FDA to take the matter to an expert advisory committee, which in July 2009 voted 14-12 to ban the drug.

But the FDA overruled the panel, instead asking Darvon/Darvocet maker Xanodyne Pharmaceuticals Inc. to conduct studies of the drug's effects on the heart. The results of those studies led to the FDA ban.

"The drug puts patients at risk of abnormal or even fatal heart rhythm abnormalities," John Jenkins, MD, director of the FDA's office of new drugs at the Center for Drug Evaluation and Research, said at a news conference. "Combined with prior safety data, this altered our risk assessment."

The FDA ban comes too late for Public Citizen, which blasted the FDA for waiting far too long to protect the public.

"Due to FDA negligence, at least 1,000 to 2,000 or more people in the U.S. have died from using propoxyphene since the time the U.K. ban was announced," Sidney Wolfe, director of Public Citizen's health research group, says in a news release.

Even if Propoxyphene did not cause deaths it does little for pain, so what was the point of it to begin with. The first time I came into contact with it was still being called SK-65 or Smith Kline 65 and was being marketed as a non-addictive pain killer. I then watched large numbers of people become addicted to it and had doctors get pissed at me for saying it was a narcotic. That was only the first time that happened others followed. Rather than think for themselves the doctors for the most part just believed whatever the drug companies told them even as they watched people become addicted to it.

Wolfe says Public Citizen will call for a congressional investigation into who at the FDA "was responsible for the loss of so many lives in this country."

Always research every drug that is prescribed for you and never under any circumstance believe the FDA is on the side of the consumer. The FDA is inundated with flexians from industry who get into positions to control decisions made in committees for corporations who then give them high paying jobs when they have served their purpose at the FDA.

Tramadol is one of the drugs being used as a substitute for propoxyphene:

From my same post in July:

I know an emergency room nurse who was working in the ER one day and had a headache. She went into the closet where all the drug samples were stored and decided to use the new drug Tramadol or Ultram, which the drug rep had told everyone worked a lot like an NSAID(Ibuprofen type). I know this because one of them told me it was an NSAID. It did not occur to her it would be a prescription drug. She kept having headaches and everyday went back more and more for Tramadol. Her coworkers were noticing she was taking a lot of it. She got addicted to it because the drug company lied. It does not make people high like other narcotics, but it is addicting. She told me she just had a feeling of looking forward to taking it everyday and was puzzled by it and then she could not stop herself from taking it. She had to go to drug treatment and participate in a chemical dependency program for nurses. She was a person who never even drank alcohol. I once got in an argument with another nurse who was on Tramadol in New Mexico when I told her it was a narcotic. She had been on it for years. I think the degree of anger that she exhibited said it all. She was defending her drug just like any other addict.

Doctors should have at this point been informed by the FDA that yes, Tramadol binds to the opioid receptors and does cause withdrawal when discontinued. They should also know people have indeed gone to rehab for addiction to Tramadol. Many people have to take pain medication and should not be stigmatized, but should certainly be told the truth about the medications they take for pain. Some people might make different choices if they had the facts.

I have found that lifestyle changes and especially diet changes have decreased my pain in a most amazing way. For example; sugar makes pain worse, while vitamin D3, turmeric, green tea and flax seeds help pain (there are actually a large number of foods which help decrease pain). The other important factors to decrease pain are exercise (remember, even a little bit does a lot) and adequate sleep. The FDA and USDA should be promoting the foods that keep us healthy and subsidize the cost so people buy more of them. Instead people eat foods full of sugar, GMO corn products and toxins which make them ill. Then after the food industry and fast food industry make their profits health care corporations, certain physicians, the insurance industry and drug companies make their profits from the effects of the poor food consumption.


Kat said...

Thank heavens! In 1973, I was hospitalized for testing because of disabling back pain.

They put me on Darvon as a pain killer. I quickly became far sicker than I was before I came in - severe headache (even worse than my migraines), pain induced vomiting, etc. This went on for three days before I connected it to the medication. I noticed that the pain receded to a large degree at the end of the 4 hr. cycle. I then refused to take my pain pill like a good little girl. They insisted I take it, but I'm stubborn and refused. They even sent the Dr. in to tell me to take it. Luckily, he didn't and gave them a dressing down for trying to make me take it. Of course I was immediately better and to this day, that's the first thing I tell them I'm allergic to. It's a demon pill.

Thanks for the good news.

Anonymous said...

We've got to make this GO VIRAL!

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Alaskan Dad said...

And the FDA has cannabis listed a schedule 1 narcotic, and cannabis is non-toxic!
Its all about the money!

Celia Harrison said...

Alaskan DAD, I would not say Cannabis in non-toxic, but since humans have used it for thousands of years our bodies are more adapted to processing the chemicals. I am pro-legalization, but anti-recreational use. Cannabis has hundreds of chemicals which work on many health problems. If we could all grow some ourselves the drug companies would loss millions and so would health care corporatons and doctors. It is certainly safer than legal alcohol. It is not just the drug companies, private prison corporations and alcohol sellers that oppose legalization, law enforcement, and those who work in government agencies that conduct the "war on drugs" want cannabis to stay illegal for job security reasons.

Celia Harrison said...

Kat, One thing most doctors don,t tell patients about narcotics is they all make vascular headaches worse. The patient gets caught up in a worse headches-taking more pain pills cycle and end up addicted. They don't give people the information to make their headaches better such as diet, adequate sleep, adequate hydration, etc.

Kat said...

Thanks Celia. My point, not clearly stated, was that I didn't have a headache at all when I went into the hospital, I was getting the Darvon for my back pain. The Darvon gave me the headache & other symptoms. I shudder whenever I think about that experience.

There are so many chemicals/drugs that are harmful the average person doesn't know about. I always carefully research any prescription before agreeing to take it. Luckily, I have a great Dr. who does the same & rarely even prescribes drugs. He's big on alternative methods as am I.

Alaskan Dad said...

ok so cannabis has some toxicity:


Toxicity is virtually nonexistent in natural marijuana. The toxicity levels of cannabis compounds are estimated at 40,000, meaning that a subject would have to ingest 40,000 times the regular dose to induce death. “In layman’s terms,” according to The New England Journal of Medicine, ”a smoker would theoretically have to consume nearly 1,500 pounds of marijuana within about fifteen minutes to induce a lethal response.”


jjm said...

Great. All the hysteria re this extremely beneficial medication has forced me - once again - to seek a substitute. Propoxyphene has been wonderful in helping me manage the many painfilled symptoms experienced from multiple sclerosis during the past 10 years. Most folks w/a chronic disease have gone through at least one hit-&-miss episode of trying to find just the right combination of drugs that work together to afford one as normal (& pain-free)
a life as possible. Propoxyphene has done that for me for many years. Previously, my doctor & I
tested many of the drugs now listed as "substitutes". When we tried propoxyphene, we finally found the best combination. Now I feel like the lost voice crying in the wilderness.