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Posted at 12:23 PM ET, 11/19/2010

Painkiller Darvon pulled because of risk to heart

By Rob Stein

The long-controversial prescription painkiller Darvon was pulled off the market Friday at the request of federal regulators.

Xanodyne Pharmaceuticals Inc., of Newport, Ky., which makes Darvon, agreed to withdraw the medication at the request of the Food and Drug Administration, the FDA announced. Companies manufacturing generic versions of the drug, known as propoxyphene, will also removing their products, the FDA said.

The FDA sought the withdrawal after receiving new data showing that the drug put patients at risk for potentially fatal heart rhythm abnormalities, the agency said.

"These new heart data significantly alter propoxyphene's risk-benefit profile," the FDA's John Jenkins said in a statement. "The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks."

The FDA said it was advising doctors to stop prescribing the drug, and asked patients taking it to immediately contact their physicians to discuss switching to another medication.

The drug, an opioid, was first approved by the FDA in 1957 to treat mild to moderate pain. It is sold under a variety of names, including Darvon, which is the drug alone, and Darvocet, which is the drug combined with acetaminophen.

The FDA has received two requests to remove the drug from the market since 1978 but had previously determined the benefits outweighed the risks. In January 2009, an FDA advisory committee recommended pulling the drug from the market. But in July 2009 the agency decided instead to leave it on the market with strong new warnings about its risks and required the company to conduct a new study assessing its safety.

Friday's action was based on the results of that study, which showed that "even when taken at recommended doses, propoxyphene caused significant changes to the elecrical activty of the heart" that can cause serious problems, including sudden death, the FDA said.

"With the new study results, for the first time we now have data showing that the standard therapeutic dose of propoxyphene can be harmful to the hearts," Gerald Del Pan, the FDA's director of the office of surveillance and epidemiology said.

Consumer advocates welcomed the announcement, but sharply criticized the agency for failing to take action sooner. Britain pulled the drug six years ago and the rest of Europe removed it more than a year ago, they noted.

About 120 million prescriptions have been filled for the drug in the United States since Britain removed the drug, said Sidney Wolfe of Public Citizen's Health Research Group, which has long called for the drug's removal.

"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 UK ban was announced," Wolfe said in a statement. He called the FDA's failure to act sooner a "serious indictment of the FDA's long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller."

Wolfe called for a congressional investigation into why it took the FDA so long to act.

During a briefing for reporters, Del Pan said regulators did not feel there was sufficient evidence to act prior to the latest data.

"The new information on the effects of the electrical activity on the heart was the final piece to the puzzle," he said.

Others said the move illustrated that the agency has become much more aggressive about removing unsafe drugs.

"It is a perfect example of how the FDA is now saving lives by reversing past approval decisions," said Diana Zuckerman of the National Research Center for Women & Families. "Patients and consumers will be healthier and live longer when the FDA is willing to put the public's health first, as it did today."

For more information, click here.

By Rob Stein  | November 19, 2010; 12:23 PM ET
Categories:  FDA, Food Safety and Recalls, Recalls, drug safety  
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Comments

My mother has a blood disease that prohibits her from taking over-the-counter pain killers like advil. She has relied on Darvon to help her deal with the pain from her multiple autoimmune diseases for years. Davon has saved her life by giving her life -- free from pain. Now that's gone. She will have to depend on Percocet, which is far more addictive and dangerous. Every medication has side effects. Even the most trouble-free medication will have someone, somewhere, who will have a bad reaction when using it. Do we just throw the baby out with the bathwater? There are millions of people who depend on Darvon to give them a pain-free life. All of these people have NO problem with Darvon. What do we tell these people? What do you do when there are NO other medications you can take to control your pain? The war on the sick continues. I weep for my mother. I'm not a vengeful person, or I'd wish my mother's life-long pain on all those who just banned her life-line.

Posted by: MarylandJ | November 19, 2010 3:39 PM | Report abuse

First Four Loko, now Darvon...

Posted by: pmendez | November 19, 2010 3:48 PM | Report abuse

"It is a perfect example of how the FDA is now saving lives by reversing past approval decisions," said Diana Zuckerman..."
@@@

I agree totally!

Americans are being overdosed by the powerful Pharmaceutical corps and it is so refreshing to see some "good people" with integrity coming forward to rescue them.

Posted by: f16poor | November 19, 2010 3:53 PM | Report abuse

I would expect that the development of safer, more effective pain-killers also played a role.

Posted by: blasmaic | November 19, 2010 3:59 PM | Report abuse

As usual our FDA takes some action years after other countries-a bit late.

Posted by: lionelroger | November 19, 2010 4:26 PM | Report abuse

Regardless of the fact this should have been done years ago, Darvocet (propoxyphene) was essentially a useless drug that presented more risks to people than was ever necessary. We not often have drugs that are used so commonly that do such severe damage to a persons bodily systems. Of course we have drugs that do damage people, but they are used with much more censure than this drug has ever had.

On another note, there are other drugs that can take its place and are much safer. Ultram for example, has about as much addictive qualities and pain fighting effects that Darvon did and is safer. Not to mention, Darvon barely killed pain better than Tylenol alone. Not worth the risk to use; I agree fully with the FDA's reasoning.

Posted by: CaptainKazzy | November 19, 2010 5:20 PM | Report abuse

I know a woman with addictive tendencies who got Darvon in the 1960s for minor pain. She eventually settled upon Valium. She should have had neither. When will we look at drugs as the LAST thing to try, not the first? What about Yoga, massage, acupuncture, physical therapy, individually-tailored exercise programs that might include all of the above? The upfront cost would be more. The patient would have to do more, including schleup to treatments. But s/he might actually get relief for the pain -- with none of the awful side effects. And s/he would be much more empowered. Pill-taking is a very passive "I'm sick. I'm weak" approach.

Posted by: catbird500 | November 19, 2010 5:26 PM | Report abuse

This is the only non-NSAID pain medication I can take because it does not make me violently ill like the others...I hope the FDA reconsiders.

Posted by: cjy56 | November 19, 2010 5:30 PM | Report abuse

Why can't reporters cite what the numeric risk is? 1 in a thousand,1 in a million?

Posted by: jfisher864 | November 19, 2010 5:36 PM | Report abuse

No medication is so ineffective or dangerous that the manufacturer can't buy enough politic influence to keep it on the market. Apparently, our FDA and Congressional representatives were busy helping out their other benefactors.

Posted by: snerdguy | November 19, 2010 5:58 PM | Report abuse

@ catbird500
As a pharmacist I have seen many people be able to live their lives in spite of pain thanks to darvon.
Unless and until you have severe pain you cannot know how dibilitating it can be.
I injurred by back using a lap top in bed. Bad posture alone caused the injury. I went for all sorts of physical therapies and in the end would wake in the night with pain shooting down my leg. The doctor said lie in bed for 2 months. Who can afford that? It was only with pain relief that I was able to continue.
I took pain killers for quite a while. It is the fear of the pain that kept me taking them. I couldn't change gears in the car without pain, I couldn't lower myself onto the toilet.
It is unfortunate that drugs have side effects and as blasmaic pointed out it is other less toxic drugs have come on the market that is part of the reason that a drug that has been sold for well over 30 years is finally found to be too toxic to take

Posted by: sushshaf | November 19, 2010 6:01 PM | Report abuse

Maryland read this again, 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 UK ban was announced,"
At first you sound like you care for your mother, now I see your ignorance getting her killed. There are several medications ''much better'' than Darvon.
Darvon is dangerous, just because it has not killed your mother yet does not mean she is safe or immune.
You are weak Republican minded gun lover who is pissed because your government is trying to protect you from danger albeit two years late.
You may or may not be vengeful person, you say your not but I think you are. There is no discussion about the fact that you are stupid betty whiner with a large gun collection.
Darvocet has been deemed dangerous,"The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks."
I imagine now you will see Lawyers on tv soon scraping the bottom for ''possible issues'' with anyone haven taken Darvon.
You will be on line I assume.
The relief you and your mother think you are getting is all in your head. And I understand if a placebo works thats great,
it did work. Mind over matter. Even placebos have side effects.
Truth is Darvon is low on the totem pole when it comes to pain killing. It never was very helpful so be thankful that your mothers life span may have gotten longer with government intervention

Posted by: Tellthetruth12 | November 19, 2010 6:03 PM | Report abuse

30 years ago Darvon was rated no more effective than otc Tylenol or asprin. Somehow it managed to stay on the market. The stuff is no loss.

Posted by: treadlefish | November 19, 2010 6:13 PM | Report abuse

Dear Sirs,

We want to add to this text that we have studied the painkilling substance propoxyphene (DXP) since 1993. Now FDA says that ONE NEW STUDY made them to stop Darvon.

We have informed FDA about our research since 1999-2000, they know about our 9-10 scientific articles about the substance, we also wrote two doctorial dissertations (2000 and 2001) in Sweden. Our research was behind the decision in UK, Sweden and The European Union (EU) to stop the drug.

Go to this link, http://www.reuters.com/article/idUSN1914706420101119

Our references are nrs 21-26.

Ulf Jonasson, Doctor of Public Health
Birgitta Jonasson, PhD

Search Jonasson Propoxyphene

Go to YouTube, Darvon, Distalgeic and Co-Proxamol. The worst drugs ever

http://www.youtube.com/watch?v=q92lL4kM-JE

Posted by: ulfjonasson | November 19, 2010 6:18 PM | Report abuse

The drug was targeted because newer drugs are three to four times more expensive, high profits rule again. Darvon and similar drugs are not a danger IF the doctor and patient have enough intelligence to monitor their use. I use Darvon on a sporadic basis during excruciating pain cycles. I don't use it every day and even when taking it, stay below the recommended dosage Result no problems.

Posted by: chkpointe | November 19, 2010 6:20 PM | Report abuse

The drug was targeted because newer drugs are three to four times more expensive, high profits rule again. Darvon and similar drugs are not a danger IF the doctor and patient have enough intelligence to monitor their use. I use Darvon on a sporadic basis during excruciating pain cycles. I don't use it every day and even when taking it, stay below the recommended dosage Result no problems.

Posted by: chkpointe | November 19, 2010 6:21 PM | Report abuse

i can understand neophyte ramblings, on this subject, i have no patience whatsoever with and agency like FDA, calling a drug an opiate, when it has never seen an opium poppy, and no studies have been released that I am aware of, and read them all on a daily basis, concering life threatening arrhythmias. this is a ploy to get a competitive product removed from the market. The trial that the FDA refers to are not and have not been made available to physicians either. This is irresponible and reprehensible action by and agency that is losing credulity on a montly basis. More is known about this pain reliever that almost anything we have short of apap and apc compound . It was created in the cold war when opium sources were behind the iron curtain. since the USA uses more opioids than the rest of the world, combinded, it was vital, and is wat started the cold war, to begin with. Dupont chemist were approaced to synthesize a molecule from polymers. they selected mepridene, not a true opioid, but quite effective. and were successful, creating darvon. please try to get some information, before you lay your crack pipes down, and start typing.

Posted by: wpierce | November 19, 2010 6:27 PM | Report abuse

Wow! I used to occasionally cop a buzz by stealing a Darvon or two out of my mom's medicine cabinet...in the 1970s. Way to get on the case FDA!

Posted by: jjedif | November 19, 2010 6:38 PM | Report abuse

Cannabis works much, much better for chronic pain and is safer than any of the prescription pain medications (or non- prescription, for that matter). Chronic users of propoxyphene- taper off, get medical marijuana. You will never regret it.......

Posted by: windhill1 | November 19, 2010 6:39 PM | Report abuse

This FDA move smells of politics. It's like the 'shakes and fries,' lobby jumping on the bandwagon to ban any substance that causes people to eat less. Meanwhile, why did the FDA act now after all these decades? If Darvon, which I've never taken, is dangerous, isn't alcohol much more dangerous? Sterling Greenwood/AspenFreePress

Posted by: AspenFreePress | November 19, 2010 6:57 PM | Report abuse

Ahh... so the answer to bad "regulation" by big govt is more "regulation"... got it... sure...

Posted by: docwhocuts | November 19, 2010 7:58 PM | Report abuse

catbird500

I can see you are not in pain. For those in constant pain, for whatever reason, need whatever helps. I am in constant pain, and tho I do not take Darvon, I need something to take the edge off, or I would be in bed constantly.

Posted by: Channah | November 20, 2010 3:58 AM | Report abuse

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