Darvocet Recall: WHY WAS DARVOCET RECALLED?

Darvocet, Darvon & Propoxyphene Recall

Darvocet, Darvon and all propoxyphene containing prescription medications (i.e. the generic equivalents of these brands) have been removed from the U.S. prescription market. The voluntary withdrawal was announced by the FDA on November 19, 2010 according to an FDA Drug Safety communication. The immediate reasons for this removal are:

  • Lack of significant benefit from these products over the alternatives
  • The risks and dangers of overdose (including accidental overdoses, particularly amongst the elderly - see link below)
  • Data that suggests a rare, but potentially serious, heart rhythm abnormality could be caused by propoxyphene usage

As a result of these things, the manufacturer of the brand name products Darvocet and Darvon, Xanodyne Pharmaceuticals, decided to voluntarily withdraw these products from the market, at the request of the FDA. Other manufacturers were notified and requested to do the same.

For an extensive report on the many documented cases of propoxyphene overdose: CLICK HERE.

A BRIEF HISTORY OF THIS DECISION

THE HISTORY OF PROPOXYPHENE WITHDRAWAL FROM THE MARKET:

1978: An organization known as "Public Citizen" petitioned the government to ban the drug, classifying it as "imminent hazard."

11/2006: Public Citizen petitions the FDA to begin immediately phasing out the drug due to dangers associated with its use.

1/2009: On January 30, 2009 a joint meeting of two FDA advisory committees was convened for the purpose of discussing the use of propoxyphene-containing pain relievers in the U.S. After reviewing the data, the individuals from this committee voted 14-12 against the "continued marketing" of propoxyphene-containing substances.

The actual minutes of this meeting can be found by CLICKING HERE.

Note: The FDA is not bound to adopt the recommendations of their advisory committees. In they case, they did not decide to request a product withdrawal.

7/2009: Then, in July 2009, the FDA decided to require stronger labeling [see image below] which would warn prescribers about the dangers of propoxyphene overdose. Additionally they asked Xanodyne for studies to help assess the potential for heart rhythm abnormalities.

11/2010: After reviewing the data concerning heart rhythm changes, the FDA decided to request that the drug be removed from the market. The result of this decision is as follows:

  • Xanodyne will withdraw Darvon and Darvocet products
  • Cornerstone Therapeutics will withdraw Balacet
  • Generic propoxyphene containing prescription products will all be withdrawn (this includes products manufactured by Zenith, Mylan, Pliva and others).

Note: Darvon Compound (a combination of propoxyphene, aspirin and caffeine), formerly marketed by Eli Lilly, has not been on the market since March of 2007. This product was available generically.

Black Box Warning Added To Propoxyphene Products in July 2009

A LITTLE INFORMATION ABOUT PROPOXYPHENE

If you have heard about the Darvocet recall, Darvon recall, or propoxyphene recall you may want to know a little more about the drug itself. Here is a very brief overview of propoxyphene:

Propoxyphene is a weak, opioid analgesic (aka a painkiller) which began to be marketed in the U.S. in 1957. It was used for mild to moderate pain. Propoxyphene was available in a variety of strengths and forms (alone or in combination with other drugs), all of which were available generically. Some of these included:

  • Darvon (propoxyphene hydrochloride) 65mg capsules
  • Darvocet N-100 (propoxyphene napsylate 100mg AND acetaminophen 650mg) tablets
  • Darvocet N-50 (propoxyphene napsylate 50mg AND acetaminophen 325mg) tablets
  • Darvocet A500 (propoxyphene napsylate 100mg AND acetaminophen 500mg) tablets
  • Darvon Compound (propoxyphene hydrochloride 32mg AND aspirin 389mg AND caffeine 32.4mg) capsules
  • Balacet 325 (propoxyphene napsylate 100mg AND acetaminophen 325mg) tablets

If you are curious about the "napsylate" name after the word "propoxyphene" it has to do with a little clever pharmacology. Propoxyphene hydrochloride could be dissolved in water and injected by patients seeking to abuse the drug. So....the manufacturers created a new form of propoxyphene (i.e. propoxyphene napsylate) which could NOT be dissolved in water and thus could not be given by injection. Pretty sneaky huh?

COMMENTS AND OPINIONS

What I have said so far are just the facts, as far as I know them, about the propoxyphene withdrawal from the market in November 2010. However, being in this profession, I am expected from time to time to give my opinion and perspective on decisions like this.

What follows are just my opinions...they are free...just remember you got what you paid for!

WAS PROPOXYPHENE A BAD DRUG?

A fair question, but the answer depends a lot on your definition of the word "bad" in this particular context. Propoxyphene, and especially propoxyphene with acetaminophen, were very dangerous when combined with other sedating medications, tylenol-containing products, or alcohol. I have had numerous customers use this product for years without problems. It helped them. That, of course, does not make it safe. But if you subtract the number of cases in which the drug was intentionally misused, or simply improperly used due to the patients age, drug profile, or health status...I believe that the actual number of adverse events would be significantly less.

DID THE FDA INTENTIONALLY SUPPRESS INFORMATION OR IGNORE DATA?

When something goes wrong, particularly with a prescription medication, we all want to blame someone. I am no fan of the shameful political maneuvering that often goes on in the drug industry. However, removing a drug from the market that has been used successfully in millions of patients, is not something that is done easily. Until just the past few months the FDA still had no reliable data that clearly indicated that propoxyphene could cause heart rhythm abnormalities that would result in clinical adverse events. All the evidence reviewed and brought before the FDA was exclusively about the drug's potential lack of effectiveness in some trials, and the significant impact (sometimes fatal impact) when this drug was used improperly. These are serious. But I do not think the FDA failed to weigh the data.

SHOULD PROPOXYPHENE HAVE BEEN WITHDRAWN FROM THE MARKET?

Given the recent data regarding heart rhythm abnormalities I think it is prudent to discontinue regular propoxyphene marketing in the U.S. An alternative approach would be to allow it with additional monitoring requirements for patients who really cannot use other alternatives. I am sorry for the many patients that this will significantly inconvenience. The reality is that some of the options for pain control that will be prescribed will create a hardship and reduced quality of life for some patients. But the majority will be able to find adequate pain control from other products. Hopefully, the withdrawal will inspire the drug industry to do further research on propoxyphene and possibly discover a similar drug without the same side-effects.

WHAT OPTIONS ARE THERE NOW TO REPLACE PROPOXYPHENE?

If you were taking one of these propoxyphene products and now must consider alternatives, you will need to discuss your options with your physician. Some possible alternatives that might be considered are:

  • NSAIDS (non-steroidal anti-inflammatory drugs): Examples include naproxen, piroxicam, meloxicam, ketoprofen, etodolac, etc.
  • Tramadol: Tramadol (brand name Ultram) is a unique non-narcotic prescription pain reliever.
  • Tylenol with Codeine: Various strengths are available by prescription. This is a Schedule III controlled substance.
  • Vicodin/Lortab/Lorcet, etc: These drugs contain a combination of hydrocodone (a cousin of codeine) and acetaminophen.

For a more detailed discussion of alternatives, go to: Alternatives for Darvocet

For more information about the FDA decision, CLICK HERE.

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Comments 33 comments

Jillian Barclay profile image

Jillian Barclay 6 years ago from California, USA

I always look to you for accurate and thorough information on prescription drugs. Again, you come through! While I do not take Darvocet, I was wondering why the recall now. You have answered my questions, as usual! Thank you!

This is not related, but I have some questions about theophylline(which was prescribed for my son from the time he was aged 2 through 10 years old). I recently heard there was a study which concluded that theophylline causes reading disabilities. I can find the study nowhere. Any info?


jasper420 6 years ago

thankyou for this hub i was wondering about this my mom takes this drug i herd something about it from her and was wondering why they pulled it


OpinionDuck profile image

OpinionDuck 6 years ago

Great job as usual on this hub.

I had the impression that the reason they took the drug off the market is because it was the acetaminophen that was more effective in the combo, and the PROPOXYPHENE was the part that was having the bad interactions.

Tylenol with Codeine: never did anyting for me except make me sick.

I had no idea that PROPOXYPHENE was around since 1957. But then knock on wood, I never needed anything above Advil, except for the broken arm, and the gall bladder surgery.

The NSAIDS while effective for me most of the time are not supposed to be good for you, especially in large doses, and over long periods of time. The Liver?

My totally lay duck opinion is that pain killers are prescribed knee jerk by doctors without a lot of analysis. Sometimes I think that a muscle relaxant would work better than pain killer if the cause is related to muscle tension. A Valium or even a Velarian could ease a lot of pain depending on the root cause of the pain.

Sorry for the duck mouth, these are just my theories.

But again great job on this hub.


pharmacist profile image

pharmacist 6 years ago from Whitinsville, MA Author

Jillian,

Thanks for your kind words. As for Theophylline and reading ability I am not aware of the study you mention. Back in 1992 a study was done, published in the NEJM (New England Journal of Medicine) indicating that theophylline use had no measurable impact on the academic performance of children. The study is found here: http://www.nejm.org/doi/full/10.1056/NEJM199209243...

But there could be something more recent. I'll keep my ears open...

Thanks!


pharmacist profile image

pharmacist 6 years ago from Whitinsville, MA Author

Jennifer,

Thanks again for your kind words. Glad the information was useful.

Blessings!


pharmacist profile image

pharmacist 6 years ago from Whitinsville, MA Author

OpinionDuck,

Thanks for stopping by and sharing your opinions. Glad to hear every perspective on these things. Best wishes!


Dr Ulf Jonasson 6 years ago

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 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://qjmed.oxfordjournals.org/content/98/3/159.2...

Our references are nrs 21-26

Ulf Jonasson, Doctor of Public Health

Birgitta Jonasson, PhD

Search Jonasson+Propoxyphene

ulf.jonasson@telia.com

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

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


pharmacist profile image

pharmacist 6 years ago from Whitinsville, MA Author

Dr. Jonasson,

Thank you for contributing your link to that helpful article. It substantiates what I mention in my article about the numerous deaths from misuse. Of course, I'm not sure about your statement that "no drug" has caused more fatalities than this one. I have seen data that puts hydrocodone much higher. Nevertheless, your opinion is appreciated. Very much appreciate your comments!

Best wishes!


Jeri 6 years ago

So now what? My family has always had a hyper-sensitivity to medications, which promote strong allergic symptoms/reactions. The list of substitutes includes everything that causes severe reactions in me, Except for tylenol. Even worse, I have just undergone surgery, and this recall/withdrawal of something that is safe and effective for my history has caused more distress. What about those of us that don't or can't asbuse this drug? Any thoughts?


pharmacist profile image

pharmacist 6 years ago from Whitinsville, MA Author

Hi Jeri,

You aren't alone, and I am sorry for what this has done for patients like you. Your situation is precisely why I supported the FDA delaying so long in this withdrawal. Taking it off the market only because some people abuse it would be like cancelling our right to speech because someone else is screaming filth and lies.

As for you...the only real option is to begin the process of finding something else to use. I wish there was an easier answer. I have written several other articles on pain medications, so maybe that would be a place to start your research. I hope you find something and that you recover quickly.

Best wishes!


OpinionDuck profile image

OpinionDuck 6 years ago

Thanks but I was interested in your opinion, I already know what my opinion was.


pharmacist profile image

pharmacist 6 years ago from Whitinsville, MA Author

OpinionDuck,

Happy to share my opinions. :)

Thanks again.


jennyjenny profile image

jennyjenny 6 years ago from Somewhere in Michigan

Thank you for an informative and thoughtful explanation. I have been taking Darvocet for a while now, on and off, since I have allergic reactions to many drugs containing codine. I also have to be careful because of complications with my heart (triple by-pass). I am a little luckier than most because now I work in a pharmacy as a tech, so I have others who watch out for drug interactions for me as well. Anyway, thanks you for your help and for sharing!


pharmacist profile image

pharmacist 6 years ago from Whitinsville, MA Author

Jennyjenny,

You are very welcome! Glad to help a fellow pharmacy professional.

Thanks for reading!


L.L. Woodard profile image

L.L. Woodard 6 years ago from Oklahoma City

Even knowing that Canada and some European countries had banned propoxyphene before the voluntary withdrawal from U.S. markets, I am not convinced the withdrawal was in the best interests of the majority of people. I suspect the FDA has wanted to act sooner because of pressure from well-meaning groups. It wasn't until the heart rhythm study results that the FDA could point to a truly valid reason--and that was in a very small number of users.

Thanks for an interesting article.


pharmacist profile image

pharmacist 6 years ago from Whitinsville, MA Author

L.L. Woodard,

Well stated. I agree with that perspective. Thanks for reading and the kind words!


Austinstar profile image

Austinstar 6 years ago from Somewhere in the universe

My husband and I both take propoxyphene and we have found it very helpful. I will miss this medication as I will now have to resort to the much stronger Vicodin which causes more side effects.

Tramadol is good for daytime use, but to ease the pain at night, Darvocet was top notch.


pharmacist profile image

pharmacist 6 years ago from Whitinsville, MA Author

Austinstar,

Sorry about the situation this removal has created for you and your husband. Thanks for sharing, as others will at least benefit from knowing they are not alone in this predicament. Take care!


robind 6 years ago

Thank you FDA for another bonehead move, don't they realize that there are thousands of people out there that manage chronic pain with Darvocet. I just went to fill my new scrip for Tramadol and it was 103.00 my Darvocet was 25.00. I don't abuse this medicene i control pain with it, i am so angry, once again the government needs to pull their head out. (please understand this was written while i was in pain)


gailbarton 6 years ago

Great...........not. I have been on Darvon for 6-7 years for chronic pain management. My doctor decided Tramadol was too risky??? Who knew?? Now what? I'd give my pain away anyday to someone who thinks Tylenol or Ibrofen works just as well....and I've tried most if not all alternatives to pain management. Not happy.


connie 5 years ago

used darvocet for severe arthritis and spurs can not take anything with codone this limits what i can take. i have had no side effects. all meds react differently to people so do we just pull everything


harriet 5 years ago

Darvocet is a good mild pain med..Just because some people abuse it the rest of us have to suffer.All meds have side affects. Now we have to go back to our chronic pain with nothing to help us except strong drugs..Thanks alot FDA


katie 4 years ago

I miss darvocet. I fractured my spine in a fall, a spine already damaged by polio, and it was my "last resort" medication. I had previously been prescribed Ultram, but an allergic reaction ruled that out. I'm eighty four years of age, and I've never abused a drug. Maybe I should consider taking up drinking!


pharmacist profile image

pharmacist 4 years ago from Whitinsville, MA Author

Katie,

I hope they can find a suitable alternative to manage your discomfort. Very sorry about the Darvocet issue.


Zharoo 4 years ago

I am really angry they pulled this off the market. I have been taking Darvocet since the 60's! Never one side effect whatsoever. Whatever the pain was, it was gone in one hour after taking Darvocet N-100. Best pain killer on earth, yet once again, our government is playing (more like screwing with...) our rights. Tramadol (sp) is a waste of money and gives me horrible hives and does NOTHING for the pain. Even mild pain. I wish I knew where they dumped the Darvocet, I'd go there with a bucket and get a bunch of it!! Any form of Codeine makes me dizzy and does not stop even a toothache! For the few it made sick: STOP TAKING IT! Why does the majority have to suffer...AGAIN???

Another angry citizen...it's time for a revolution, folks!!


Desert Billy 4 years ago

I FULLY agree with Zharoo !!! I am a physician..broke my back 1985..using Darvocet 1985-2010...NO PROBLEM !! Codeine like meds-itch/goggy/DIDN'T WORK like the propoxyphene !!! Tramadol-doesn't make it !! 25 years of doing well..as an adult..I am willing to accept ALL responsibility for using the med !! I prescribed the med for 33 years..NO PROBLEM !


Desert Billy 4 years ago

I still agree with myself !!! Signed, Desert Billy

P.S. Is there ANY chance of propoxyphene coming back to the US market ? I have looked and apparently I can get a "90 Day" supply from Canada ..asked about it when I was in Australia last year.."Nope !! We followed the FDA's lead and took it off the market!!" I am WILLING to sign anything to show I ACCEPT the risks !!25 YEARS of use..NO PROBLEM !!!


Kelly from NC 4 years ago

I was also pissed to see darvocet taken off the market. I've had chronic neck pain and recurrent migraines since aug 2006 and the darvocet worked wonders!!! No side effects, no addiction to it, nothing. Just finally relief from horindius pain I will have to deal with prob for the rest of my life. I have been switched to tramadol which doesn't work unless u take at least 3, which isn't healthy!!! Hydrocodone is way too addictive; speaking from experience. If they won't return darvocet, are they working on anything similar? If it had bad side effects for u personally, don't take it! Simple as that! Don't ruin it for the rest of us!! Looking for better pain options ASAP!

Contact me if u have any info @ kgfreeze@netzero.com


pharmacist profile image

pharmacist 4 years ago from Whitinsville, MA Author

Kelly,

I'm afraid I am not aware of any studies being done to bring it back to the market. Sorry about that. As you can see from the comments, you are not alone. I hope you find something that helps.


Danny Twilley class of 65 4 years ago

hey......treat the cause not the symptom........there is no end to symptom if you do not address the cause............most chronic pain syndromes are unknowingly caused by the patient!


TigerLily 3 years ago

The reason they took it off the market is in robind 's post, "I just went to fill my new scrip for Tramadol and it was 103.00 my Darvocet was 25.00. "

This was about forcing patients onto the latest and greatest drugs that are probably more addictive and for sure have way more side effects. That would be true for tramadol. And it doesn't work for tooth pain. Makes me sick, and woozy but I still have the pain. Darvocet, no wooziness, no sickness and no pain.


Marcolady 2 years ago

I, too, have taken Darvoset off and on for 30 years for intermittant back pain, and it not only totally took away the pain, but there were no side effects. I could work and function normally. Since the FDA took it off the market, I have tried Tramidol which didn't touch the pain and made me woozy, Oxycodone which really made me dizzy, and codene which made me sick. None of those touched the pain. I read somewhere recently that some people tried Methadone and experienced similar results as with Darvoset--pain gone and no dizziness. Is this an alternative?


pharmacist profile image

pharmacist 2 years ago from Whitinsville, MA Author

Marcolady,

Good question. Moving from Darvocet to Methadone would be a huge move upwards in pain management and potential for addiction. That would not typically be a recommended step. Celebrex recently became available generically. Might ask your MD about that.

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