Xartemis XR

I recently saw an advertisement for Xartemis XR. The new opioid is overpriced, completely unnecessary, and dangerous. Xartemis XR is essentially OxyContin with acetaminophen (INN: paracetamol), aka Tylenol, added. Tylenol alone kills or hospitalizes more people than all legal opioids combined. The US government has a campaign against the unnecessary use of acetaminophen because of the hepatotoxicity of acetaminophen, even when used within guidelines.

Daily intake of acetaminophen (APAP) should not exceed 2600-3000mg (THREE GRAMS) per day and it should NEVER be taken on a regular basis because even normal doses of acetaminophen can be toxic after two weeks.

Tylenol is added to Percocet & Vicodin for ONE REASON, as an abuse deterrent. Unfortunately, that doesn't work, people just get acetaminophen poisoning.


Extended release opioids are primarily intended for long term use by chronic pain patients, so who is this stupid product intended for?


Xartemis XR (oxycodone/APAP extended release) is a SCAM to extort more money from insurance companies and cash in on the current climate of opiophobic hysteria. If your doctor tries to prescribe this for you, ask them why they are giving you an expensive name brand drug that is inferior to the generic alternatives and push for something better.

Fear Of Addiction Means Chronic Pain Goes Untreated | Health News Florida [Transcript]

Fear Of Addiction Means Chronic Pain Goes Untreated | Health News Florida [Transcript]
http://bit.ly/1iJH9Vs

Dear Stupid (doctors)

Pills for Breakfast: Dear Stupid - National Pain Report
http://bit.ly/1ji4mN4

Doctors are stupid, especially the ones at Mayo, UPenn, Hopkins, Cleveland Clinic, and all of the other "must go" hospitals. I was never treated worse than when I went to Johns Hopkins (Baltimore, MD), UPenn (Philadelphia, PA), and Milton S Hershey Medical Center (Hershey, PA). They give up on us the second we get complicated.

FDA: Naloxone Injector Not Just for Drug Abusers - National Pain Report

FDA: Naloxone Injector Not Just for Drug Abusers - National Pain Report

http://bit.ly/1kEtGLQ

This is SCARY! This device would be scary enough, but to advocate its use on pain patients is somewhere between malpractice & medical terrorism. Instead of reposting my thoughts here, I've included the comments that say it all.

Even if unconscious, it is illegal to administer naloxone unless you are a doctor or an EMT being actively advised by a physician. I doubt that these laypeople will bother along for consent. Without significantly training (like the REMS programs for Accutane & Xyrem), this is scary.

Why was this rushed through approval?

~~~~~
Kurt says:
April 4, 2014 at 7:14 pm
I guess I need a new Medic Alert tab for my necklace in case I faint the next time I am in Safeways shopping for dinner, and succumb to shock over the high prices they’re charging these days for a pound of hamburger.

I am a chronic pain patient maintained on opiates.

DO NOT INJECT WITH NALOXONE. I am opiate tolerant and not likely to overdose on opiates. Naloxone could put me into immediate opiate withdrawal causing a health crisis.

Lord keep us safe from do-gooders.

~~~~~~~~~~~~~~~
Steve says:
April 7, 2014 at 6:36 pm

Exactly, Kurt! Thank you!...

[trimmed]

...I’m considering a permanent tattoo claiming allergy to naloxone. I already have a DNR refusing naloxone, but where I live DNRs are ignored in the prehospital setting (ambulance, etcetera), which is why I’m thinking about the allergy tattoo, I’d love your thoughts.

~~~~~~~~~~~~~~~
Steve says:

April 7, 2014 at 6:29 pm
Naloxone only reverses opioids, but the vast majority of overdose deaths are not opioid only, they usually involve alcohol and/or benzodiazepines (Valium/diazepam, Xanax/alprazolam, Ativan/lorazepam, etcetera)

This is deeply rooted in opiophobia.

Also, of they really wanted to help people, it would be OTC or OTC worth log book (like pseudoephedrine/Sudafed), but then they wouldn’t benefit from Rx insurance reimbursement. This should be “Pharmacy Only Medicine”, like Imitrex in the UK, where you don’t need a doctor’s prescription, just counseling with the pharmacist (slightly more restricted than Sudafed because training should be required).

This product is used to COMPLETELY reverse opioids, which is fine for an opioid-naive overdose, but would kill an opioid tolerant IP patients like myself. Without dose control, it could kill. Without dose control, I’d imagine most Heroin addicts will refuse a dose because every documentary that I’ve seen involves a human going around with naloxone and they always have trouble convincing these people to take the naloxone. They frequently convince them to take half of a dose.

Pain patients rarely overdose. Family members who can’t mind their own business and don’t know ANYTHING about opioids will abuse this and/or abuse their pain patient family members.

This is all about money, generic naloxone is ~$0.50/dose

Steve

ACLU Sues over Mandatory Drug Tests - National Pain Report

ACLU Sues over Mandatory Drug Tests - National Pain Report

http://bit.ly/1eWLOjN

FDA Approves First Device to Prevent Migraines - National Pain Report

FDA Approves First Device to Prevent Migraines - National Pain Report
http://bit.ly/1eWKqO2

Feds Investigate Walgreens Over Privacy Concerns - National Pain Report

Feds Investigate Walgreens Over Privacy Concerns - National Pain Report
http://bit.ly/1pefSuh

Anything to different from the discrimination of CP/IP patients.

Drug Maker Blames ‘Misinformation’ for Zohydro Controversy - National Pain Report

Drug Maker Blames ‘Misinformation’ for Zohydro Controversy - National Pain Report
http://bit.ly/1peed85

FDA Hears From Fibromyalgia Patients - National Pain Report

FDA Hears From Fibromyalgia Patients - National Pain Report

http://bit.ly/1pec1gP

Don't forget to read the comments.

FDA approved Fibromyalgia drugs cause side effects more often than relief

Drugs for Fibromyalgia: How Good Are They?- National Pain Report
http://bit.ly/O4OAth

Lyrica provides relief for 10% of patients, Cymbalta 6%, and Savella 8-10%.

Technically, 1 in 10 patients reporting significant relief from Lyrica/pregabalin is better than placebo, which is all that the FDA requires for approval (the major flaw in the FDA approval process).

"In the case of Lyrica, randomized controlled trials have shown that doses of 600 mg daily produce drowsiness in 15-20% and dizziness in 27% to 46%.

Other side effects include dry mouth, weight gain, peripheral oedema (swelling). In another important review, it was found that treatment was discontinued due to adverse events in one out of 4 patients."

Fibromyalgia patients deserve pain medication, not placebos that cause massive weight gain and fatigue.

For those that get relief from them, opioids (as well as Xyrem/sodium oxybate) should be made available to them. Enough of these useless antidepressants. Enough of making Fibromyalgia patients feel bad because they don't respond to these useless drugs. Enough of shaming Fibromyalgia victims for requiring opioids.

Chronic & Intractable pain victims are not addicts and we are not criminals. We shouldn't be treated any different from a diabetic refilling his insulin, metformin, Actos, or Byetta.

It's bad enough that opioids are withheld from most chronic pain patients, especially Fibromyalgia patients, but to give them drugs that are useless for their pain condition (they might help for depression), all while telling them that the drugs are specifically approved for their condition, is inhumane and cruel.

-Steve

"In summary, a minority of patients will report substantial benefit with Lyrica, and more will have moderate . Many will have no or trivial benefit, or will discontinue the drug because of adverse events."

“Doctors are men who prescribe medicines of which they know little, to cure diseases of which they know less, in human beings of whom they know nothing.”

"Those who have been awarded a diagnosis of fibromyalgia find themselves in a “double bind.”

On the one hand, the very diagnosis can arouse disbelief at all levels of society and, on the other hand, the available drugs afford most of them little, if any, relief of pain."

Article: Fibromyalgia Mystery Finally Solved! Researchers Find Main Source of Pain in Blood Vessels

Fibromyalgia Mystery Finally Solved!
Researchers Find Main Source of Pain in Blood Vessels

http://bit.ly/1c4Q0yu

This is a more laymen-friendly version of an article from several months ago that explains that Fibromyalgia isn't Psychiatric, but neuropathic. The pain is the result of abnormal nerve fibers, which improperly manage the blood vessels. This article focuses on the fact that Fibromyalgia is not Psychiatric, but I'll repost the more in depth article later.

The worst part is that, thanks to the War on Drugs, War on Doctors, and the newest war, the War on Patients, Fibromyalgia patients will still be given useless SSRIs (Prozac/fluoxetine, Paxil/paroxetine, Zoloft/sertraline, etcetera), SSNRIs (Cymbalta/duloxetine, Effexor/venlafaxine, Pristiq/desvenlafaxine,  tramadol/Ultram/Ryzolt, Nucynta/tapentadol, Savella/milnacipran, etcetera), and mood stabilizers (antipsychotics & anti-epileptics; gabapentin/Neurontin/Gralise, Lyrica/pregabalin, Lamictal, Abilify/aripiprazole, Seroquel, etcetera). Unfortunately, antiopioid propaganda and the DEA are preventing most physicians from prescribing pain medications for pain. Opioids are the safest (especially in the longterm), most efficacious (with adequate dosing) solution for any chronic pain condition.

Remember, acetaminophen/paracetamol/Tylenol alone kills more people than all opioids combined. NSAIDs aren't as deadly as acetaminophen/paracetamol, but they're still more deadly than opioids. Actually, even diacetylmorphine/diamorphine/Heroin rarely kills on its own, drug abusers die from mixed drug toxicity (combining alcohol and/or sedatives with opioids). Of course, opioid related deaths are almost all drug abusers. The statistics are never deaths caused by opioids, they're "opioid related deaths" or "drug related deaths", meaning any death that occurs with a drug peripherally involved, even if it is completely unrelated to the actual cause of death.

Steve

I'm pissed...

I'm pissed! In an effort to minimize the use of controlled substances, especially in children, doctors like to prescribe powerful more stabilizers (Lamictal, risperidone/Risperdal, Seroquel, etcetera) for pain and sleep. I myself was a victim of this kind of inappropriate prescribing.

Now, I'm bombarded with reports that THESE MEDICATIONS (Risperdal/risperidone, Seroquel, Lyrica/pregabalin, and gabapentin/Neurontin/Gralise/Horizant) ACTUALLY CAUSE PAIN!!!

I've known for years that Risperdal/risperidone is responsible for the painful facial tics, but the idea that these medications are actually causing or exasperating the conditions that they treat. That's like prescribing high dose acetaminophen/paracetamol/Tylenol for the pain of liver failure!

Do I believe that Risperdal is responsible for 100% of my pain? No, but my doctors are constantly telling me that my tumor on it's own should not be causing the severe, crippling pain that I'm experiencing on a daily basis and there isn't a doubt in my mind that this illegally marketed drug is responsible.

Risperdal could have been replaced with the following safer, cheaper alternatives:
1) melatonin (OTC supplement)
2) Z-drugs- zolpidem/Ambien/Intermezzo, Sonata/zaleplon,eszopiclone/Lunesta, zopiclone/Imovane/Zimovane/Imrest (Rx, controlled substances)
3) benzodiazepines, like lorazepam/Ativan (Rx, C4)- ideal for stress induced insomnia where you can't quiet your brain (exactly what I experienced)

Rozerem (Rx, non-controlled substance) was not approved at the time, but is currently very useful.

So why was I given an antipsychotic? Because the manufacturer illegal advertised off-label use and bribed doctors into prescribing it.

That is why the anti-controlled substances environment that we are living in is so dangerous.

Steve

OT- Banned4Life Project

The Banned4Life Project
www.banned4life.org

Even the Red Cross doesn't believe that a lifetime ban on blood donation for gay men is warranted, but the FDA refuses to look at the facts.

My best friend from middle school is gay and HIV+. He obviously should be banned from giving blood until we find a cure, but not every gay man is at high risk of HIV+, it's all about behavior and a more complex and accurate set of questions should determine deferral length or ban. Monogamous homosexual men are considered by the FDA to be a higher risk than heterosexual men who regularly engages in unprotected sex with multiple prostitutes.

The risks you take and the threat that you pose should determine your ability to donate DESPERATELY needed blood.

As someone who might need blood one day, it scares me that stereotypes will determine the quality of blood that I get, instead of the actual risk.

The petition:
Banned for Life- Causes
https://www.causes.com/posts/833577
http://bit.ly/B4Lpetition

Paying for it

I spent a few hours volunteering at the local animal shelter yesterday. I WAY over did it yesterday, and now the nerves in my legs are on fire. I can practically trace the nerves because they're so inflamed. I missed our weekly outing with our daughter (museums, historical society, hikes, parks, carnival, Army war college, etcetera) this morning. This afternoon, I didn't get to go to the animal shelter (my wife still went and helped for two hours). And now, I'm missing out on going out with some of the people at the shelter (my wife got both of us invited while  I slept and she volunteered).

I'm not sure which is more frustrating
1) constant, unrelenting pain
2) inconceivable BTP (breakthrough pain) flares
3) missing out on everything (family stuff, social stuff)
4) NO ONE gets it

I think the worst part of this is that none of this is necessary! I'm in pain for no legitimate reason. My pain was under control (bad, but under control) with low dose methadone, Actiq, Duragesic, and oxymorphone. My pain was virtually eliminated with 3mg/day intrathecal morphine. I feel like the one sane person in a world of crazy. I feel like I'm screaming and no one is listening. I'm in excruciating pain, there's medication that can fix it, I'm insured, my insurance will cover Duragesic, Actiq, methadone, oxymorphone, AND an intrathecal pump, I have NO risk factors (including NO family history) for abuse, I don't smoke, I don't drink, I've never abused my medication, I've never been high, I have cancer, I'm dying, I've never run out of meds or needed an early refill, I've tried EVERY non-drug treatment recommended, I've tried every non-opioid, I've tried every single weaker opioid, I'm beyond compliant, I keep myself informed (as instructed, although it's being used against me now)... and, STILL, I'm treated like shit and get inadequate treatment.

How does this make any sense to anyone?

Steve

Update

My wife and I had our quarterly checkup with our PCP Wednesday night. As some of you know, my wife and I are under-medicated because of a number of factors, including Opiophobia, the semi-recent increase in the War on Drugs, and the fact that our PCP also does Suboxone (treats addicts).

Our PCP still refuses to increase our Duragesic. My wife was switched from OxyIR to oxymorphone, after months of requiring that multiple doses of OxyIR 30mg. He wasn't as stingy as when he put me on oxymorphone, but her pain is finally diagnosed (EDS, type 1 & 2), but he still a bit stingy.

After 7-9 months of begging for an increase, he finally increased my oxymorphone again. It's still nothing collapsedl compared to the Actiq that he refuses to prescribe since he's started doing buprenorphine/naloxone treatments (generic Suboxone and Suboxone film, mainly the film according top the literature the drug reps litter the office with). That is also why he refuses to use methadone for pain management.

Wow, off-topic, sorry. Still waiting on insurance approval, fingers crossed that we get approved and that these help.

Wisdom

"You know that old saying... Those who can, do. Those who can't, sign our paychecks. Change that last part to make the laws."

Courtesy of Cabot