Subsys Fentanyl Under Federal, State Investigation

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Santa Clara, CA: Insys Therapuetics, the makers of Subsys Fentanyl, a powerful and addictive painkiller delivered as an oral spray, is now the subject of investigations by both federal and state attorneys general offices in California, Massachusetts, Connecticut, Arizona and Illinois, according to a report by

Fentanyl products are considered among the most potent and dangerous opioids on the market, at about 80-100 times stronger than morphine. The oral product made by Subsys gets into the bloodstream faster than with traditional methods of delivery because it is sprayed under the tongue.

Among the concerns intended to be addressed by the investigations is that Subsys Fentanyl is being prescribed off-label, which while legal if physicians deem it appropriate, is illegal for pharmaceutical companies to market a drug for off-label use.

According to the report by CNBC, Insys allegedly not only marketed Subsys off-label but also paid medical professionals in the hopes they would write more prescriptions of the drug.

Fentanyl is used to treat chronic pain. Dr. Larry Epstein, a New-York based anesthesiologist who specializes in chronic pain management, told CNBC that doctors are now taking "hundreds and hundreds of patients off of these medications."

"We made a lot of addicted people," Epstein told CNBC. "But it's not so straightforward. And sometimes we don't know the answers until we make the mistakes."

The dangers of fentanyl use first became public knowledge with reports of serious side effects and deaths associated with the Duragesic pain patch (known generically as Fentanyl patches). They are linked to a risk of fentanyl overdose, which could result in respiratory failure, permanent coma and death. Due to problems with manufacturing of the Duragesic pain patch, the patch has been the subject of multiple recalls, although Duragesic patches are still available on the market.

In June 2005 the Duragesic product label was given a black-box warning label explaining the risk of accidental fatal overdose and respiratory depression or hypoventilation.

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Reader Comments

Posted by

Being a chronic pain patient with over 30 surgeries from losing spleen, which caused abdominal hernias, cut breast to naval and having mesh put in, stapled back with 38 staples, then mesh tears out and repeat, this is a ongoing thing. After about 7 or 8x its said allergic to mesh, replaced with gortex, couple tearouts then snaps on one side wraps around intestines cuts off bowels, and again breast to naval, reinstall different mesh *originally Marlex not sure what is there today. Then gall bladder open surgery, mrsa, lets not forget Necrotizing Fasciitus with 2 hrs to live it cost 57 days 9 surgeries later I am still having issues a year in a half later, contracted c-diff in hospital and now lost almost 85 lbs with no trying. I have been in and out of er with utis and pneumonia and chronic pain with being diabetic also peripheral neuropathy to the point I begged to have my feet cut off. I can truthfully say I had a good 4 mos of being normal when I was given 60mg OxyContin 3x a day with 30mg oxycodone ir 2x a day, plus I was prescribed 12 diludads for serious need. All that and still neurpathy ate me for lunch..Lyrica is the ONLY thing that works to help that type of pain. I am shocked that people are asking for opioids for it. Its known fact opioids do not work for is a nerve issue it needs a med that acts upon nerve damage. I have nothing but pain when I do not have lyricia and that is when my meds helped all but that nasty chewing and electrical nerve damage.In march of 2016 there were new laws imposed on pain meds and prescribing drs. Now Insurance is taking over orders drs have written, and people who have no irons in fire or no pain are making the rules about how much one can have. They are more interested in making money on boxes that are supposed to electrically help pain and tells your brain you don't hurt. My brain knows I hurt, and there will be no one or nothing that changes that.

Posted by

I have suffered with pain most of my life. I was born with a birth defect that caused me to be hospitalized the first few years of my life. When I was 22 I lost my breast to a rare disease. And during this time was diagnosed with degenerative back disease. After all of this, in 2010 I was diagnosed with cancer and underwent chemo and radiation only to be followed by surgery which has left me with a permanent ostomy.
I was lucky enough, at the time I went through treatment, to have a pain management doctor who prescribed me SUBSYS, after none of the traditional medications worked. After about a year the government stepped in, or so I understand, and started threatening her with the loss of her license.So, of course, I agreed to have my pain medicine reduced, which meant the loss of the SUBSYS, and actually switched pain management care to a research facility in hopes that I could receive some help in getting my life back in order.
(Considering my days and nights now consist of laying on the couch, looking out the window, asking God if I can die now.)
The doctor I have now, in his own words, * I am 1 in 1 million people that end up with neuropathy as bad as I have it now due to cancer treatment.
I guess my point is, how can the government be allowed to judge my level of pain? And then get away with regulating the amount of pain medicine people get by threatening the doctors?
I believe I could just about speak for everyone with chronic pain. We much rather not hurt than to have the medication.

Posted by

I recently was taken to the hospital with chronic pain, and in the ambulance I was given fentanyl orally, I was a little disoriented when I got to the hospital, but pain stopped, then the doctor put me on a 100 mg of fentanyl patch, and sent me home, bye the evening I was about to faint could not breath, I could not hold up my head are lift my body, vomiting and nausea, could not remember nothing, just sic, emergency room told me I had been overdose bye the fentanyl patch, and I should not of been given such a strong dose, are not at all. a second day I was taken back to the emergency room vomiting, and dizzy it took me two weeks to focus on anything. could not think. I was told they give that patch to people who are dieing, and it is the strongest medicine there is for pain, why is it that they give it to anyone, I almost died, heart rate and blood pressure was high. I was given meds to get fentanyl out of my system, I had very dry month, so was difficult to talk for days.

Posted by

I have suffered with very painful peripheral neuropathy, which is a degeneration of the nerves in the extremities, for over 16 years now. The only reason I am alive today is because I found a very kind pain management doctor who was willing to prescribe opiates at a dose sufficient to make my pain bearable, otherwise I would have committed suicide by now (which I came close to doing before my pain was brought under control). Fentanyl has been used as a part of my pain management regimen for breakthrough pain. It has allowed me to have a little bit more normalcy in a life than consists of mainly lying in bed watching TV because it is very painful to put pressure on my feet. It is true that opioid users develop a tolerance and require increasing doses, and that there are some who become dependent on the medications, but what other option is there? Allow patients to suffer with severe pain because insurance companies find Fentanyl medications too expensive to pay for, and doctors are afraid to prescribe them for fear of legal action? Those who have not suffered severe, chronic pain do not understand how difficult it is. Don't let legislators, lawyers and insurance companies determine what medications are ok for patients to use for pain management. Allow trained physician to make that decision!

Posted by

Let me draw a picture of how (legitimate) chronic pain patients have to work to overcome the challenges of chilling legislation, myths about opiate meds, and ambulance chasing lawyers who make physicians think twice about treating those so afflicted. First the heavy hand of the law makes most physicians either dismissive of pain (no matter how well documented) or just refuse to treat those requiring opiates. It is very difficult. Also, narcotic pain meds are now rationed. Pharmacies have a fixed amount they can order which is based on averages they filled years ago. Do you see a problem with that since we have an aging population that lives longer? Doctors have too much invested in becoming a MD. The vast majority, if forced to choose b/t treating a legit patient or risking litigation or loss of respect or association of peers, they will almost always tell the patient to take a hike. All respected research shows opiates, taken by legitimate pain patients, as prescribed, and supervised by a MD are safe long term. To the man above who said that fentanyl is like "crack cocaine" (I can only assume you actually meant smoking meth, idiot), there is no research to show fentanyl products can cause dental problems. The only thing that fentanyl has to do with tooth loss is causing dry mouth (xerostomia). You sir, failed to take care of your teeth (or smoked meth) and are responsible for the inevitable outcome. Do not seek some scummy attorney to take your fraudulent case before a jury. People that suffer on a daily basis do so not because they have to, they suffer because it is near impossible to overcome the problems they face getting access to care. Shady lawyers and politicians who have yet to experience the horror of daily chronic pain are the enemy. Those who put these barriers in place, I hope you experience unmitigated pain for an extended period of time (maybe at the end of your insensitive life) and see what it is like to be in that kind of pain and no physician willing to treat you due to the inconveniences you helped put in place. If you find yourself in this position, I hope, for your sake, guns have not yet been banned.

Posted by

I had been using the patch for about three years and the dose was being increased about every 6 months up to 150mgh. I never got great results from it but it did take the pain edge softer. It was a very empty life being on the patch really had no desire to do anything anytime. Ended up with major depression and on a host of meds for that. I finally changed doctors and my new doctor eventually took me off the patch. But the damage was done. After using the page for several years I found a tooth in the back of my mouth just disintegrated. So I went to the dentist and he told under the gums all my teeth had rotted out. I ended up with upper and lower dentures. It was explained to me that fentynal works in a similar way as "crack Cocaine" which rots you teeth out.
It cost a small fortune to get the dentures make and all my teeth removed.
Do you think this has the potential to file a law suit?
Thank You

Posted by

I was taking the spray and using patches after I had a major back surgery. I had a lot start going on with my body and also became addicted to the medication. a couple times I had to go to the hospital after using some of the products.

Posted by

My father was never prescribed this medication. But he passed away in 2006, I was told by my uncle that he gave my dad a pain patch.

During the time of my dads death, my grandmother didn't want me to order my dads death certificate. Well me not knowing why my dad died, I ordered his autopsy report.

After 4 long months of my dads dead, being labeled as undertermined. I finally get the report and fentanyl is one of the drugs in his system.

Now my dad has never been a drug user, he just drank his red wine. Along with this med was a few others that can only be prescribed by a health doctor.

My dad only went to the Veterans Hospital for care and this med has not been prescribed for him. Who is held accountable my uncle for giving it to my dad or the drug manufacturer?????

Posted by

I was on up to 100 mgs of fentynal patches and other narcotics for years to manage pain and now nothing works and I'm left not only in pain and very difficult working but may also loose my social security as they see it as if I'm not on it I'm ok to wk. Full time. Couldnt be farther from the truth as nothing manages my pain now except steroid and lidodetm injections that by the time the surgeey is recovered from monthly only a few weeks pass and i need more.

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