Propoxyphene aka Darvocet "Voluntary" Withdrawal

[Koolau]

Was just ordering meds (no, the real ones) from our pharmacy. When I got to Darvocet, they indicated that they could no longer get it. Apparently, their source has withdrawn it from the market. FDA has supposedly put pressure on the major manufacturer of propoxyphene and they have "voluntarily" complied. It's not "illegal", but it's not going to be available because of FDA's influence.

Xanodyne agrees to withdraw propoxyphene from the U.S. market

Don't know if anyone else here uses propox. drugs (Darvon, Darvocet, etc.) but DW and I have both found it to be safe and effective (yeah, I know, it sounds like a commercial). Anything "weaker" doesn't do much for pain and anything stronger is dangerous for addiction - yes, I know there is some addiction potential for propox., but that's why it's high on the FDA schedule - well, that's actually a whole other story. But, the point is, FDA can't protect us from e. coli, but they don't mind taking away our only good pain medication on what seems like more of whim than any real evidence. The stuff has been on the market for 53 years. Don't you think they would have found heart problems before now? This is (I think) the most prescribed pain med on the market. You'd think they were finding bodies in the street or something.

In case you think maybe I'm a little p*$$ed, I guess you are right.

DW and I both have arthritis (hers is the crippling kind). We take NSAIDS which help with the chronic part of the diseases, but acute pain is often an issue. Anyone know of another pain reliever which will allow DW to get out of bed in the AM and let me sleep through the back pain at night?

 

[grumpy]

Koolau,

I can't take NSAIDS due to stomach issues. I now use the time release version of Ultram (ER). It is a synthetic narcotic and does a pretty good job of keeping my pain tolerable.

I can understand your frustration. I did VERY well on VIOXX until it was taken off the market. I think the FDA should leave such decisions to patients in consultation with their doctors so long as the risks are clearly identified.

 

[Koolau]

Thanks, grumpy. DW already takes the occasional Ultram for another issue. It does seem to work, but gives more of a buzz than propox. So, we've been concerned about addiction and 1 + 1 + 1 (NSAIDS, propox., Ultram) = 7?

I'll have her ask her Doc (and I'll ask mine) about Ultram as a replacement.

Thanks again!!! That's why I hang around here. We've got the smartest and most experienced folks (with time on their hands, heh, heh).

Would be interested in folks take on the FDA as well. To remove such a product because it seems "stylish" to do so seems unconscionable. Hope that's not too political (as it's neutral WRT party). Or maybe I'm just in a bad mood.

 

[W2R]

Good idea for you and your wife to talk to your respective doctors about what pain medication would be effective and safe for you.

 

[GregLee]

Would be interested in folks take on the FDA as well. To remove such a product because it seems "stylish" to do so seems unconscionable.

I don't understand your beef with the FDA. According to the link you gave us, “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 heart,” which sounds like a substantive concern, rather than a stylistic one.

 

[Koolau]

I don't understand your beef with the FDA. According to the link you gave us, “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 heart,” which sounds like a substantive concern, rather than a stylistic one.

If we assume that FDA has "legitimate" data showing potential harm to the heart, that's still only half the question. As you know, all drugs are harmful (e.g., side effects) or else they have no effect. But what is the benefit to the organism? (i.e. pain management). Throw in the fact that other (substitute) pain meds are (or may be) MORE injurious to the the heart and other organs and you may not be able to make the case FDA has made. I'd like to see the data. I'd like to see them make the actual CASE against propox. Simply saying it is "harmful" would condemn every drug. If they could even say "We don't need propoxyphene because methyl ethyl chickenwire is just as effective - but safer." then we could have a discussion. Propoxyphene is a rather unique drug in that it is very effective for long periods of time with limited (and mostly known after several billion doses have been taken) side effects. I'm guessing that only a.s.a, acetaminophen and ibuprofen have been used more than propox. in the past 50 years for pain. I don't have the figures so I'll say "I'm guessing" that a.s.a has killed many more people than propoxyphene. Yet, you can buy pounds of a.s.a without any restriction.

Again, if this were a new drug, I might be concerned about this new "data". But since propox. has been around for 50 years, i think we would have seen evidence of significant heart-related issues by now.

My "beef" with FDA is that I'm willing to take my chances with propox., my Doc is willing to take my chances with it, my insurance company is willing to take my chances with propox. and NOW we have even more DATA (well, maybe) to make the decision about taking my chances. But FDA says "no", you, your doc, your ins. co. can no longer decide what is in your best interest. "We have spoken."

 

[Nords]

DW and I both have arthritis (hers is the crippling kind). We take NSAIDS which help with the chronic part of the diseases, but acute pain is often an issue. Anyone know of another pain reliever which will allow DW to get out of bed in the AM and let me sleep through the back pain at night?

Dr. Terry Vernoy was getting a little grumpy last time I saw him about my ACLs (3-4 years ago?), but back then he said that he had a list of over two dozen painkillers. He started with OTC (ibuprofen) and moved up from there. (I believe next up was Naproxen.) He said that sometimes it took almost 18 months to work through all the choices, but that every patient eventually found their niche.

If your doc doesn't use the same system then you might want to give Vernoy or Dr. Kahn (Queens) a call. They do a lot of reconstructive and arthritis work.

 

[Koolau]

Dr. Terry Vernoy was getting a little grumpy last time I saw him about my ACLs (3-4 years ago?), but back then he said that he had a list of over two dozen painkillers. He started with OTC (ibuprofen) and moved up from there. (I believe next up was Naproxen.) He said that sometimes it took almost 18 months to work through all the choices, but that every patient eventually found their niche.

If your doc doesn't use the same system then you might want to give Vernoy or Dr. Kahn (Queens) a call. They do a lot of reconstructive and arthritis work.

Thanks, Nords. I realize there are some newer meds on the market now, but both DW and I (especially DW) went through this exercise, starting about 25 years ago. Oddly enough, the best NSAID for DW was Benoxiprofen. It worked amazingly well for her. Unfortunately, it was badly prescribed (some Docs said "take as needed for pain") and it was eventually removed from the market because it was literally killing people with liver toxicity. Turns out that it required especially close monitoring as the difference between efficacy and toxicity was only about a factor of 2. That doesn't mean it was a "bad" drug. It just meant that Docs really had to earn their money when prescribing it. Because they didn't, the world lost an excellent weapon in the "war on pain".

Anyway, DW went through a total of 6 or 8 NSAIDS since then. For acute pain, she started with ASA, then went to acetaminophen, then naproxin (IIRC) then I honestly forget, but she pretty much tried them all. When they all failed, she tried Darvocet. It worked so well it was a minor miracle which is still working almost 25 years later. That's why it's so disheartening to hear this news. Those who have never experienced chronic pain with unpredictable bouts of acute, unrelenting pain probably can't relate to being willing to take a drug which might kill you (not very likely, actually, but possible) to get some relief. Darvocet has allowed DW to have a life - in combination with NSAIDS.

Our Docs are with Queens, so if we need to, I'll ask them to get Drs. Venroy or Kahn involved. Thanks again!

 

[obgyn65]

+1

Good idea for you and your wife to talk to your respective doctors about what pain medication would be effective and safe for you.

 

[Nodak]

I'd bet dollars to donuts that whatever replaces Darvocet will be MUCH more expensive.

 

[Moemg]

If you don't already I would recommend trying a pain clinic .They just focus on chronic pain . There are several procedures they can do to help plus regulate your medications .

 

[DblDoc]

Would be interested in folks take on the FDA as well. To remove such a product because it seems "stylish" to do so seems unconscionable. Hope that's not too political (as it's neutral WRT party). Or maybe I'm just in a bad mood.

My take. It took too d%$n long. Propoxyphene is very addictive, has a poor side effect profile, including causing dangerous arythmias, and was removed from the European market years ago Propoxyphene (Darvon, Darvocet) Withdrawl Was Long Over Due Per Reports.

Talk to your doctor about alternatives such as hydrocodone and non-narcotic pain relief.

FWIW you are going to see an increasing shift away from the prescribing of narcotics. They have become the fastest growing category of abused drugs, last year they were responsible for more deaths than any other drug (except alcohol). The US consumption of prescription narcotics far and away exceeds any other country. We, and many other ER's, will no longer prescribe Schedule II medications (These include oxycodone and benzodiazipines such as valium). In addition our prescriptions will be for a very limited amount, will not be for chronic pain issues and no refills for any reason.

DD

 

[Koolau]

My take. It took too d%$n long. Propoxyphene is very addictive, has a poor side effect profile, including causing dangerous arythmias, and was removed from the European market years ago Propoxyphene (Darvon, Darvocet) Withdrawl Was Long Over Due Per Reports.

Talk to your doctor about alternatives such as hydrocodone and non-narcotic pain relief.

FWIW you are going to see an increasing shift away from the prescribing of narcotics. They have become the fastest growing category of abused drugs, last year they were responsible for more deaths than any other drug (except alcohol). The US consumption of prescription narcotics far and away exceeds any other country. We, and many other ER's, will no longer prescribe Schedule II medications (These include oxycodone and benzodiazipines such as valium). In addition our prescriptions will be for a very limited amount, will not be for chronic pain issues and no refills for any reason.

DD

You're the (double)doc, but I was under the impression that hydrocodone was more of an addiction/abuse potential than Darvocet. I know when DW took it after her knee replacement it made her suicidal. Switching to Darvocet worked very well for her with no "buzz" or other unpleasant side effects present with hydrocodone. I realize everyone's body works differently, but neither of us have developed a dependency and only take it for "episodes" of pain - not on a daily basis.

DW has tried several of the non-narcotic options and none seem to give much relief (arthritis EVERYWHERE). She does use an NSAID (mentioned earlier) which gives some relief for the chronic effects of the disease(s) but doesn't do anything for the flair ups she's prone to. She has seen at least half a dozen docs and they all say she's doing everything she can at this point.

I understand that the feds are after you docs for prescribing pain killers, but I think it's time for y'all to stand up to them if you think a patient needs something to make life worth living. If you think "abuse" (as in "street selling/buying") is a problem, just wait until folks who are in real pain can no longer get help from their docs. At least you as a doc are monitoring your pain patients for abuse (e.g., blood tests, physical exams, "talking to them" - or maybe not anymore). When pain patients have to buy their meds on Broadway, you will be getting calls from the ER about your patients. With all the issues of pain management, it sure would be a better situation to thave the docs dealing with it than "Lefty" on the corner.

Not suggesting you feel this way, but more than one doc has suggested to my wife that she "just deal with it". Good thing I wasn't in the exam room with the doc at that time or he would have needed some meds. So, if you don't know chronic and acute pain, then walk (hobble) a mile in DW's shoes.

Because we've recently moved and have entered an entirely new network of docs, I'm hopeful that maybe they will take her seriously and perhaps send her to a pain specialist as you have suggested (she suggested this to at least two of her docs over the years and got the "just deal with it" answer.)

Just my opinion as a patient and one who watches his wife "just deal with it".

Anyway, thanks for the advice (ooops, I mean suggestion). We'll try to take it.

 

[Nords]

Just my opinion as a patient and one who watches his wife "just deal with it".

Maybe you've already tried this, and I'm trained as a scientist and engineer, but if you're approaching the end of the rope then I have a serious suggestion:
Try a Chinatown acupuncturist. I don't have a particular name (spouse did this in Bangkok) but you undoubtedly know someone who knows someone who knows every square block of Chinatown. You want the guy who's about 300 years old, with lots of long sharp shiny needles and heat lamps, who maybe doesn't even speak English and has a family member translating for him. No teas or potions or salves, just hardware.

I don't know or care whether it's the placebo effect or simple thermodynamics or an ancient Oriental channeling through qi points. Months later spouse is still talking about how effective the pain relief was.

 

[grumpy]

I agree with Nords - I also had good pain relief from a Chinese acupuncturist when I lived in Maryland. Unfortunately it is a 100 mile drive from where I live now in Virginia. The one acupuncturist I tried in Va. wasn't nearly as effective. Give it a try.

 

[oldtrig]

Would I ever trust someone sticking needles in me?? Could you trust these people to be clean and use clean needles?? I have been taking Lortabs for over 20 years and never got addicted to them. I can go months at a time and never take one. If they are used for pain and not fun then they are safe in my opinion.

I also tried the celebrex, Vioxx and Bextra. I felt like a young person again until my stomach starting bleeding, not good. So I am like one of the other posters, I cannot take this type of pain meds. The Ultram (ER) constipated me . I also took the 50m tramadol and thought they were safe to take when needed. I decided to stop taking them after using them for two years and talk about something hard to do. These so called safe pills are not candy and for me it was as hard as when I stopped smoking.

Go to some of the forums and read about people that stop taking ultram and tramadol. I had most of the problems these people had. I have not took one in three months and never again will I use them. I envy anyone who has never had pain. I have a friend who is 66 and never had a headache. Some are lucky. oldtrig

 

[Nords]

Would I ever trust someone sticking needles in me?? Could you trust these people to be clean and use clean needles??

I guess we'd have to compare the patient-infection rates of acupuncturists to the rates of clinics & hospitals...

 

[Koolau]

Maybe you've already tried this, and I'm trained as a scientist and engineer, but if you're approaching the end of the rope then I have a serious suggestion:
Try a Chinatown acupuncturist. I don't have a particular name (spouse did this in Bangkok) but you undoubtedly know someone who knows someone who knows every square block of Chinatown. You want the guy who's about 300 years old, with lots of long sharp shiny needles and heat lamps, who maybe doesn't even speak English and has a family member translating for him. No teas or potions or salves, just hardware.

I don't know or care whether it's the placebo effect or simple thermodynamics or an ancient Oriental channeling through qi points. Months later spouse is still talking about how effective the pain relief was.

Thanks, Nords. We'll look into that. We now have several friends who have had acupuncture and swear by it. In the much more Asian culture we have here, acupuncture is simply accepted as another treatment option by many. It always seemed a bit like voodoo or witchcraft to me, but you are right - when you get to the end of the rope, you'll try anything. I'd prefer a pill like Darvocet (with whatever side effects). One other issue with AP, of course, is the cost. Have no idea what that is, but I know of folks who go "regularly" for AP treatments. It can't be as cheap as $10 for 200 Darvocet. Still, if AP can give DW relief, it would be worth the cost, I'm sure. I'll try to get her to mention it to her new doc who is of Asian extraction. She may not have the prejudices against AP that our docs on the mainland had.

Thanks again.

 

[Koolau]

I also tried the celebrex, Vioxx and Bextra. I felt like a young person again until my stomach starting bleeding, not good. So I am like one of the other posters, I cannot take this type of pain meds. The Ultram (ER) constipated me . I also took the 50m tramadol and thought they were safe to take when needed. I decided to stop taking them after using them for two years and talk about something hard to do. These so called safe pills are not candy and for me it was as hard as when I stopped smoking.

Go to some of the forums and read about people that stop taking ultram and tramadol. I had most of the problems these people had. I have not took one in three months and never again will I use them. I envy anyone who has never had pain. I have a friend who is 66 and never had a headache. Some are lucky. oldtrig

FDA seems to think that "other" "just as good" "just as efficacious" meds are just "out there". If they find out Darvocet is bad, folks can take one of the other, pain relievers. I am SO glad there are a lot of them to choose from. But as your experience shows, none of them are without side effects and none of them are risk free. Further, not all of them give the same relief to EVERY patient. We all react differently which is why some folks die on operating tables from the anesthetic alone - no other cause. But we've decided that it's worth it to have 1/20,000 never wake up from an operation than to ban GAs.

I guess this is where I part ways with DblDoc. I'm sure he is correct about the side effects of Darvocet. But, if you read any of the literature on the NSAIDS (and believed them) you'd never take them. Still DW and I both have taken NSAIDS for years. They could cause either of us virtually instant death due to heart attack or even massive stomach bleeding (both have happened to other NSAID patients). Yet, with our doc's watchful eye, blood tests, checking for bleeding, etc., we've decided to take the risk for the benefit - in DW case, they have slowed the progression of joint loss. In my case, they have allowed me to live a much less painful existence. Is that worth the risk of death? Each of us has to make that decision with our doc. When FDA takes another "arrow" out of the doc's quiver, it hurts patients. Why not give all the facts to the doc, let the doc 'splain those risks to the patients and let them decide if the risks outweigh the benefits.

One more time and then I promise to shut up on THIS point. Darvocet isn't new. It's been around a very long time and has been given to (wild a$$ guess here) hundreds of millions of people. If we were talking thalidomide (or even Celebrex) here, the side effects would have created grave yards if Darvocet were as bad as FDA seems to think. Is Propoxyphene more "dangerous" than was thought in 1957, yeah, probably it is. In those days (in doze daze) clinical trial sizes were a few hundred people instead of the 10,000 or so that some current trials use (which STILL MISSES side effects, like, oh, I don't know, how about DEATH?) Sorry, I was waxing sarcastic again. Gotta stop that.

Thinking about changing my tag-line to "God protect us from those who wish to protect us." Has the same sentiment, but maybe just a bit edgier, doncha think?

 

[toofrugalformycat]

Koolau - I'm sorry you and your wife are in pain. I just found this thread while searching for another subject.
I've been in both acute, and chronic pain from arthritis over the years, so I know what you are talking about. I'm glad you are engaging with your doctor, and I hope you will continue to try new things. I am not a medical professional. But I have gone from crippling arthritis pain (difficulty even walking, unable to sleep) to 99% pain free, and drug free, by dint of physical therapy and bracing. It took several physical therapists over the years, and new technology (knee bracing has gone from not recommended, to very effective externally worn carbon fiber!). I spend 1.5 hours at the gym most days. It is a huge time commitment. It won't work for everybody. But pain reduction and increased functionality is well worth it for me.
I've got the "good" kind of arthritis (osteo) but ask your doctor if keeping moving is recommended for you. They have learned so much over the last 30 years, especially about physical therapy. Drugs are not a cure, as you know, and in my experience, they were only useful to get me over the hump of pain to where I became fit enough to exercise enough to get the muscles strong enough to support the joints.
End of infomercial.
About the Darvocet - I read up on this earlier because an elderly relative was on it when the FDA recalled it. The good news is that it is not very effective as a painkiller, so if it was working for you, I'm hoping you can find something else not very strong that might work for you.
FDA: Darvocet must warn of overdose risks - Health - Health care - More health news - msnbc.com
"At FDA's January meeting on the drug, officials cited studies showing most of the pain relief from Darvocet came from the acetaminophen component."
I hope things work out well for you and yours.

 

[GregLee]

I spend 1.5 hours at the gym most days.

I told my wife about this (she has osteoarthritis in her knees), and she wanted me to ask whether the exercises you do would have to be done at a gym.

 

[Koolau]

Thanks, toofrugalformycat. You give some very good advice. DW has had some success w/both PT and bracing. Unfortunately, our insurance is very stingy w/PT and the bracing has been figured out on our own. DW definitely has OA (within the last 10 or 15 years) but her original form of arthritis appears to be RA. Unfortunately, the tests used to diagnose RA are not always definitive, so after 35 years, there is only an assumption of RA from the symptoms.

I am going to get aggressive with the new Doc and insist that she treat DW aggressively. If that fails, we'll keep looking for a new Doc.

The issue of Darvocet working primarily by the "acet" portion doesn't seem to hold up for DW. She's tried straight acetaminophen without much relief. I know that's not a controlled study. I know FDA (and its minions of helpers who seem to have come out of the wood work for the past 40 years) have often tried to say that propoxyphene "doesn't work", then they switched to "it's a drug of abuse" and got it put on the schedule (funny that it doesn't work, but you can abuse it) and now "it'll kill you" though we can't show you the grave yards. It's taken 53 years, but they've finally done what they've never been able to do in the past (and not for lack of trying.)

We'll keep looking and working with Docs, etc. on this. It's frustrating and disheartening but it has to be done. Thanks to all for the suggestions. We'll follow up on them. This is a good forum of folks with good minds and better hearts!

Much Aloha

 

[Nords]

I told my wife about this (she has osteoarthritis in her knees), and she wanted me to ask whether the exercises you do would have to be done at a gym.

Thanks, toofrugalformycat. You give some very good advice. DW has had some success w/both PT and bracing. Unfortunately, our insurance is very stingy w/PT and the bracing has been figured out on our own.

I tore both ACLs about nine years ago and kept re-injuring my knees. After my second round of physical therapy I still had stability problems from sloppy ligaments and atrophied quads/hamstrings. I had to be careful how I walked and turned, I could barely jump rope, and I certainly wasn't willing to try to do a full squat. Every time I'd try to build up the muscles I'd re-injure something.

A taekwondo instructor suggested custom-fitted rigid-frame carbon-fiber orthopedic knee braces. (He wore them for his knee injuries from a car accident.) They've been around for a while, and some college/professional football teams even fit their linemen for them as part of their safety gear. They're incredibly light yet strong, and they can be adjusted (by the owner) to limit excess knee flexion while stabilizing the joint. They can even be designed to "unload" a meniscus. I got carbon-fiber ones because they're very nearly metal-free and thus could be approved for taekwondo sparring.

Over four years ago I spent $1700 for a pair from Honolulu Orthopedic Supply. (Orthopedic Shoes, Back & Neck Supports | Honolulu, HI) It wasn't clear whether Tricare would pay for them so I paid the full retail. They've life-changers for stability and exercise. They don & doff with velcro straps in about 30 seconds, and they're not even hot or sweaty. I wore them for about two years as I built up my muscles through squats & lunges (and taekwondo). I still keep them around for heavy yardwork (lifting & hauling 70-100 pounds) but otherwise my knees are back to full strength. I get all the knee exercise I need from jumping rope, squats, and lunges-- no gym required.

I'd highly recommend visiting their business for show & tell. The technology is far & away better than anything you usually encounter in orthopedics, along with versions specifically designed for professional athletes (slalom skiing, volleyball, and basketball) and women.

 

[toofrugalformycat]

I told my wife about this (she has osteoarthritis in her knees), and she wanted me to ask whether the exercises you do would have to be done at a gym.

No, I think you could manage without. I do use a leg press but it seems like you could figure some way to fake that or buy a machine for home. You can also do leg extensions with a weight strapped to your ankle, sitting on a table (in fact that's how I do it). I go from one kind of low-to-no-impact cardio machine to another (a couple variations on elliptical and various bicycles) but that is mostly to avoid boredom. A stairstepper is better but my new cheapo gym doesn't have one and I'm doing ok without it. I could probably manage with just our exercise bike at home, especially if we sprung for cable tv or netflix or something to relieve boredom.

The thing is to get a good physical therapist who is new, or keeps up with the new stuff, and will work with you, and takes you seriously.

 

[toofrugalformycat]

I am going to get aggressive with the new Doc and insist that she treat DW aggressively. If that fails, we'll keep looking for a new Doc.

Much Aloha

You are welcome, and I wish you success on your journey.
If you want PT you may have to request PT, rather than wait for your doctor to suggest it.
My orthopedist (who is a surgeon) thinks "aggressive treatment" means knee replacement. The last two times my knee acted up - 2 years ago and about 8 years ago (a piece of scar tissue breaks off with a crunch and floats around - ouch) I go to him, he x-rays it, tells me I need a replacement but I'll know when I'm ready, I demand a prescription for physical therapy and a new brace, and within six months, I'm better than before the crunch because I have been given better exercises and a better brace (and maybe because I listen better to the PT, too, and request/demand diagrams).

I know PT can be really expensive, though, so I feel your pain about that, too! I only had to go a few times, then I continued on my own.