Is Exalgo™ “Safe” for Chronic Pain Management?
In 1995 we were introduced to a new chronic pain management medication that was marketed inappropriately and eventually became a national problem. The medication was OxyContin. Now fifteen years later we have a new medication much more potent than OxyContin, and unlike OxyContin’s once every twelve hour formula this new medication is once every twenty-four hours.
This new medication is named Exalgo™ and is time-release hydromorphone. It was approved by the US Food and Drug Administration (FDA) on March 1, 2010. Exalgo™ is the only extended release (ER) formulation of hydromorphone available in the United States.
Presenting at the American Pain Society’s 29th Annual Scientific Meeting, Perry G. Fine, MD, of the Pain Research Center at the University of Utah’s School of Medicine, Salt Lake City, provided an update on the management of moderate to severe pain, with the goal of achieving around-the-clock relief. He focused specifically on Exalgo™, a once-daily novel treatment for chronic pain that delivers hydromorphone via the OROS delivery system, which uses osmosis to provide a steady rate of drug release. Exalgo™ is available is 8, 12, and 16 mg tablets.
I am very concerned as this medication is meant for someone who has been on strong opioid management for a long period of time. As a matter of fact the manufacturer—Covidien—posts the following warning for their product.
The indication for EXALGO is once daily administration for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. EXALGO is contraindicated in opioid non-tolerant patients, in management of mild pain or pain not expected to persist, in patients with compromised respiratory function or in patients with narrowed or obstructed gastrointestinal tract or with known hypersensitivity to any components including hydromorphone hydrochloride and sulfites. Concurrent use of EXALGO with CNS depressants, including alcohol, increases risk of respiratory depression, hypotension, and profound sedation, potentially resulting in coma or death. Not recommended in patients who have received MAO inhibitors within 14 days of starting EXALGO.
A major reason for my concern is that opiate-naïve patients would be at serious risk for an overdose and could die. In addition, there is an even greater possibility for people to divert this drug for illegal sale; which could also lead to many more overdose cases and deaths.
However having shared my concerns, I also want to share my hope. My belief is that no medications are “bad” but how they’re used and who they are used with can either help or harm. We need to be vigilant and use a multidisciplinary team in collaboration with the patients and their family members to monitor any potentially risky medication like OxyContin or Exalgo. We also need to make sure the medication is not being abused or used to cope with psychological, emotional or lifestyle problems. We need to teach everyone on the team how to recognize red flags for medication abuse or addiction.
To learn more about potential medication problems in chronic pain management please check out my article Addressing the Problem of Perscription Drug Abuse/Addiction in Chronic Pain Management that you can download for free on our Article page.
If you’d like to receive training for helping people with chronic pain and coexisting disorders, including addiction, I’m very excited to announce we are presenting my Addiction-Free Pain Management® Certification Training in Sacramento on August 5-7, 2010. To learn more about this and my other upcoming trainings you can check out our Calendar page.
You can learn more about the Addiction-Free Pain Management® System at our website www.addiction-free.com. If you or a loved one is undergoing chronic pain management, especially if you’re in recovery or believe you may have a medication or other mental health problem and you want to learn more effective chronic pain management tools, please go to our Publications page and check out my books; especially the Addiction-Free Pain Management® Recovery Guide: Managing Pain and Medication in Recovery. To purchase this book please Click Here.
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July 4th, 2010 at 2:21 pm
Just started this med after using methodone for several years for extreme low back pain. It does not work as well and am not hoes not work as well as methodoneppy with it.
July 4th, 2010 at 3:17 pm
NOT HAPPY WITH THIS MEDICATION.
July 15th, 2010 at 10:12 am
These concerns could be applied to a number of medications, such as duragesic patches, which I’ve used for about 9 months for chronic back pain. Patients must be opioid-tolerant to take any of these type of drugs. Can it be abused? Of course, but this doesn’t mean we don’t need these type of drugs.
“A major reason for my concern is that opiate-naïve patients would be at serious risk for an overdose and could die.” Duh. No doctor should prescribe these medications to patients who are not opioid-tolerant. If someone takes this drug who did not get it through their doctor, and they have severe side-effects, is there any way to prevent that? We can’t determine what drugs are made available to people with common sense and real health issues based on idiots who decide to take drugs not prescribed to them. I hope that’s not what you’re saying.
July 24th, 2010 at 1:48 am
…I just started Exalgo 8 mgm just over a week ago and have started to feel some positive benefits…after having been through the gamut: MS Contin for years, regular hydromorphone, years and years of Vicodin HP, and recently having been on Opana for a few months I apparently am finding some relief…I realise that I am only a week or so into this new therapy but for the first time in years I am actually hopeful after my cervical reconstruction post MVA….I wish to return to work and become productive to society once again….
July 27th, 2010 at 3:28 am
I started on Exalgo, 16mg once a day approximately 6 days ago. I had been on the fentanyl duragesic patch 150mcg every 2 days with MSIR 30mg 4 times a day for breakthrough, then when I couldn’t deal with the unreliability of the patches I was switched to just MScontin 60mg x 3 times a day and it wasn’t helping my pain at all, all that it did was keep me from getting sick from withdrawal. I am very opiod tolerant, and have been on opiates for almost 3 years. I had a severely herniated disc at C6-C7 which was taken out and replaced with an artificial disc last monday 7-19-2010. I gotta say, that now with the Exalgo 16mg daily coupled with oxycodone 15mg 6 times a day I am actually getting real relief from my pain. Instead of being a 7 or an 8 on the pain scale, I am finally having days in the 4-5 range. I am so grateful for this medication. It really works well for me.
September 3rd, 2010 at 11:23 am
I just started this medication it does not work for me! I have had 2 back surgeries and the last was a spinal fusion at the L-4 and L-5 I have been on oxycotin for 3 years 40mg twice a day and 5mg every 6hrs for break thru pain. I was feeling ok with this and could fuction. My doctor decides to change what was already working to this drug which is not working at all even with me taking my 5mg of oxycodone for break thru. I can understand trying something new and trying to limit the doses but I have a damaged siactica nerve and the pain is horrible I am so frustrated that im worse now than before!!!!!! Im on 8mg daily maybe my dose isnt strong enough but I cant live like this unless u have been thru it u have no idea!!!!!!!!!!!! I will see my doctor in 2 weeks to let him know if this helps I may be contacting him sooner if this doesnt improve.
September 7th, 2010 at 1:46 pm
I am very opiate tolerant and have been receiving treatment for my severe back pain resulting from four severely herniated disks in my back which are in my thoracic and lumbar spine; Which I think is the result of complications from my cervical spine breaks three years ago from a roll-over accident going 70mph on the freeway. I shattered C6 and cracked C7 and now my herniated disks are much lower in my back and I have pinched nerves and severely herniated disks however no neurosurgeon will operate on due to the fact that I am only 22 years old and they don’t want to risk me not being able to walk anymore. However the pain I experience on a daily basis as I’m sure some of you know is crippling in itself, I have good days and bad days but on bad days the pain is so severe that getting out of bed is not an option the pain from my disks are much more severe than my spinal break even (I assume because the herniated disks are lower in my spine). However with this new medication I have begun taking EXALGO 16mg once daily along with Hydromorphone 4mg IR 5-6 times daily I have finally found some relief and my is never gone but has been greatly reduced with this medication from a 9 or 10 on the pain scale down to about a 5 which makes everyday tasks manageable and will allow me to go back to work and continue my life and rejoin society without living every second in such severe pain so I say thank you to the EXALGO and I have found great relief in it and its long acting formula. I found that this medicine is good but only with additional breakthrough pain treatment as well.
October 18th, 2010 at 6:53 am
I have tried everything under the sun and exalgo seems to be working well for me. Recently I have tried embeda 100mg twice a day, opana er 40 mg 2x a day and mscontin 40 mg 2x a day and nothing worked good enough to where I didnt need my breakthrough oxycodone 10/325 4-6 a day. I started the exalgo last week and I feel it is working good. After the 3rd day of being on it I started to feel real relief without the drug feeling which I hate! Thats why I didnt like the mscontin! I have pain and need pain mgmt I dont like to get high on my meds! I want them to work and thats it! Nothing more! For those of you who dont think its working make sure you give it time to fully get into your system. It takes 48-72 hours to fully work. Good luck to everyone in pain looking for relief. Ive had chronic pain for 2 years and I am so thankful for doctors and medicines like this. The more medicines that work and dont mess with your head the better! Thank you exalgo!!
October 29th, 2010 at 9:48 am
I had my L5-S1 fused in 2004 and been dealing with killing pain in lower left and right side back. Dr. think it is SI Joint related but nothing is helping it is getting harder and harder to work a full 8 hour day and most of it is thinking how bad your back hurts and you just want to lay down. Nothing is working I have been on diffrent meds since 04 latest is 24mg Exgalgo, 2 Percocet 10 for break through and still in 7 or 8 pain level. I am 42 and not seeing any rainbows in my future.
November 20th, 2010 at 5:09 am
I had 3 L4/L5 back surgeries 11 yrs ago and have been on Oxycontin for 10 of the 11 yrs. (240mg/day) Yesterday my pain dr switched me to Exalgo 16 mg 2x/day; 30mg Oxycodone for breakthrough pain. I haven’t gotten the new rx yet, but, I main concern is drug withdrawal while my receptors are adjusting to the switch. I was wondering if anyone experienced this problem. 8 yrs ago my Oxy’s were stolen out of my house..I didn’t realize it was desirable back then and didn’t lock up my meds. One of my kids friends stole my entire script and my dr wouldn’t replace them immediately. I layed in bed for 10 days with absolutely horrible withdrawal. So, this has stuck with me since it happened and I can honestly say that this is a concern for me. I know it’s time released but I just wondered if I’m going to have any problems with that. If anyone has any experience or knowledge..please let me know. Thanks
November 27th, 2010 at 5:06 pm
I am 62 and I have been on various meds for the past 4 years for cronic pain in the upper and lower back, both arms and left leg. I currently use Lidoderm patch 3 a day, hydrocodone 7.5/325, 6 a day and now have started Exalgo about 4 weeks ago and have noticed a great improvment, I am currently taking 56mg of Exalgo along with hydrocodone for breakthrough pain. Because of Exalgo I can now do small tasks, in time I hope things will keep improving.
December 14th, 2010 at 9:15 am
I started taking Exalgo one week ago,16mg 6 x day, and have had some relief. I find it better than some past meds I have been on, Oxycontin 80mg 2x daily with oxycodone 30mg 4x day, Actiq lolipops 1200mcg 7x day and various other combinations of other meds the last 8 years. I still hurt but right now I see some hope.
January 20th, 2011 at 5:53 am
This medication Steve Harrison is not given 6X a day the max dose is 64mg a day. not only that its 24 hr medication with break threw pain reliever for lull moments when exalgo relaxes in the body, the Dr can not give and will not give it as you describe maximum dose is maximum dose. I ve been on this since Feb 2010 and just titrated to 64mg 1 time daily this medication is not PRN if this is given to you somehow as your dose by your Dr He is a quack trust me.
February 7th, 2011 at 6:03 pm
Bo, please accept my humble apology for saying 6x daily. It is 6 16mg tablets once daily and 30 mg oxycodone 4x daily if needed. And do not call this man a quack because he performs procedures on my back with the skill that is unmatched by any of the other surgeons who attempted to hit the right spots in my back and neck. And the pharmacist told me that there are people on higher doses than 96mg daily and were written by other doctors from other practices. Thank you for your time Dr. Bo and once again please forgive me for my faux pas.
February 14th, 2011 at 12:36 pm
hi i was put on exalgo 12 mg 1-2 tablets a day i have lower back problems from a fall about a year and a half ago i had been on perkasets 10-325 every 4 hours. exalgo made me light headed but didnt take any of the realy bad pain away i called my pain doctor and told him and he told me 2 take them back 2 the pharmacy before i write you anything else if i had breakthrough pain medician i might b ok exalgo bottle f 30 cost over 400 dollors
March 22nd, 2011 at 6:09 am
Exalgo is very exspensive! A bottle of 100 pills 16mg is 2000$! Thank god for insurance! I have been on 80mg Oxys 3x day with 30mg oxycodone 4x. I just started 2x day 16mg exalgo with breakthrough meds still and i have RSD which is a chronic nerve disorder due to surgeries (5) on my R knee. I also have low back pain due to a nuerostimulator implant that doesn’t work now. I haven’t had a day under a 6 since 2003 and I am actually feeling like a 3 right now! I would also say to those of you thinking about taking this med.
LET IT GET INTO YOUR SYSTEM! I had an awful transition day of a 10 almost all day but the next morning I felt really good! So give it a chance to work but yes another fast acting pain reliever will be needed most likely. Your doctor can also transition you slowly with this medication!
July 2nd, 2011 at 3:51 am
Hello, I was diagnosed with SyringaMyelia, it only hits about 1 in 2 million people a year, but it really hurts when you have it, I was on methadone for over 21yrs. guess I am an addict, do not care, methadone worked for me without any opiate problems at all. Now methadone will not work at all, so the dr. prescribed exalgo, she is not going to prescribe, breakthrough drugs at all, which is a problem for me, exalgo only works about 12hrs. not 24 as told me. If you know of any other pain centers that will work with me, let me know, I am in Spokane, WA. thank you, Jack, still in pain, burns
May 10th, 2012 at 10:38 am
My heart goes out to all who are taking opiates for chronic pain. I used to be on massive quantities for years and finally got sick and tired of being sick and tired. Instead of pain relief, my pain was worse. Instead of being a productive member of society I became more withdrawn and unable to function. I decided enough was enough and quit taking them about 5 years ago. The withdrawals were insanely horrendous. I will never take another opiate again. I broke my knee about 4 months after quitting the pill cycle and refused any opiates. I survived just fine. I’ll take pain over being a slave to opiates any day, thanks.
By the way, I changed my lifestyle, lost 65 pounds and exercise regularly. My pain is manageable now. I take the occasional aspirin. My injuries are still present and the pain does come around, but I can manage it without opiates. Diet, meditation and exercise are my medication. I feel free and clear and normal. You can, too.
July 13th, 2012 at 12:11 am
You guys who are saying “it’s not working anymore” about the methadone - or any other opioids for that matter - means YOUR TOLERANCE is too high! It’s not the drug that has changed…
If you want that feeling again, and let’s be honest here, you know what I’m referring to - then you have to lower your dose and lower your tolerance, and then go back up. You’ll never get the full feeling back, anyway. Welcome to being dependent on a drug! Now, addiction and dependence are two totally different things - and I’m not going to say anyone here is an addict…That’s for you to figure out on your own in your own time… But reading all these responses, it is pretty clear to see the dependency on opiates.
Really sad. I know how it is. My doc started me on prescriptions when I was just 19 and I didn’t even know what I was taking other than I knew it made me feel normal. And now, a decade down the line, I am clean from illicit drugs but none the happier…Getting clean isn’t all it’s cracked up to be, but you can’t go back to using. So