Impact of Approved Drug Labeling on Chronic Opioid Therapy; Public Hearing; Request for Comments
cder cder2012179 labeling  opioid public hearing drugs chronic pain extended-release  long-acting  ER/LA opioid  REMS abuse
2013-04-09 2013-04-01 2013-03-29 2013-03-29 2013-04-01 2013-04-01 2013-03-22 2013-03-25 2013-03-25
FDA-2012-N-1172-0248 FDA-2012-N-1172-0210 FDA-2012-N-1172-0189 FDA-2012-N-1172-0195 FDA-2012-N-1172-0207 FDA-2012-N-1172-0202 FDA-2012-N-1172-0091 FDA-2012-N-1172-0130 FDA-2012-N-1172-0145
04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0248 https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0210 https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0189 https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0195 https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0207 https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0202 https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0091 https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0130 https://api.regulations.gov/v4/comments/FDA-2012-N-1172-0145
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Created in 2009, the Chronic Pain Research Alliance (CPRA)  led by the National Vulvodynia Association, Chronic Fatigue and Immune Deficiency Syndrome Association of America, Endometriosis Association and The TMJ Association  has served as the first and only collaborative advocacy effort dedicated to advancing both disorder-specific and collective federal research efforts on eight prevalent, but longtime neglected disorders that frequently co-occur and disproportionately affect women. They include: vulvodynia, temporomandibular disorders (TMD), fibromyalgia, endometriosis, chronic fatigue syndrome (CFS), chronic headache, interstitial cystitis/painful bladder syndrome and irritable bowel syndrome. As highlighted in the landmark 2011 Institute of Medicine Report, Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education and Research, millions of Americans suffer from one or more of these disorders at an enormous cost to both the U.S. economy and to the individual sufferer. Only a handful of treatments have been approved by the FDA for the treatment of five of these disorders, and despite their widespread prevalence, cost and life-altering impact, no FDA-approved therapies exist for vulvodynia, TMD and CFS. In addition, the federal governments investment in researching these disorders is poor  averaging just a couple of dollars per affected individual, and only a handful of clinical trials are currently studying the effectiveness of treatments to manage these conditions. The result is that sufferers are routinely misdiagnosed and shuffled from office-to-office in search of a diagnosis and effective treatment; when a diagnosis is made, very little scientific evidence exists to inform treatment recommendations, and the afflicted are left to try to gain some semblance of quality of life by stumbling upon an effective treatment(s) through the only option available to them  many months (and often times years) of trial-and-error. An expanded I have RSD. the only thing that allows me to live as normal a life, raise the last 2 of the 4 children I have, coach their teams, go to PTA, Hold down a full time critical Gov job and get thru the day without crying too much is because I have NORCO. would i choose to take this? NO. I would much prefer to live a normal life. Some days I take what is prescribed, some days i take 1 or none. It depends, but let me ask you something. If someone you loved, God forbid as I wouldnt wish RSD on The worst people in the world, your Mom, Dad, Wife, sister, brother or child had RSD and it felt, on a daily bases and even while sleeping, that their bones were being stabbed from the inside with a hot poker, their muscles were being eaten by fire ants while getting the worst indian burn ever, to the point their skin felt as if it would tear, would you want them to have relief from that? That is what I go through daily and some have it worse. But Im guessing as Doctors or FDA employees, no one in your family would have to suffer needlesly that way. Please, Please dont let the A-Hole celebrities and recreational drug users put us back into dispare. There is a reason they call RSD the suicide disease. thank you for your time.....mary The NFMCPA understands reasonable and necessary safety measures, but we believe the recommendations for severely restricting opioids (hydrocodone  oxycodone): 1) to a maximum daily dose equivalent to 100 mg for non- cancer pain ans 2) a maximum durations of 90 days for continuous daily use are EXTREME MEASURES! I have been living with chronic, unrelenting pain for the past 20 years and will suffer severe  consequences from such restrictions. No alternative treatments are being offered. I object to the FDA changes for more stricter hydrocodone product prescribing by changing them from Schedule III to Schedule II classification of drugs. My doctor    prescribes medications to treat my chronic pain. He is the one who should decide what his patient needs, and not the government. Thank you. I am a sufferer of Chronic severe pain due to Fibromyalgia. I have pain that on the 1-10 pain scale is a 25.I have been on the narcotic Oxycontin 80 mg twice a day for about 15 years.I take it as prescribed only.Even with this strong pain med.I still have to take Nucenta for breakthrough pain and I take Ibuprofen 600mg three times a day.I certainly did not ask for this horrid pain which is frequently worse than some cancers.I do work a part time job and have a small home business but if my dose is lowered or my pain med.taken away I will be non-functional and then need to be on government disability.Also,the pain would be so severe that either I would die from the pain or I would have to take my life.This I am sure goes for many pain sufferers that legitimately need pain control.We are not addicts.We need our legitimate pain controlled.I am sure you want me and other pain suffered to be productive members of society.Thank You for reading this. Jodi M. I have RSD for 10 years now. 8 months ago my husband and I moved to Spokane WA. We moved from Nevada were I finally was starting to able to things like walking my dog. It took 2 long years changing my meds. I have RSD in my left shoulder all the way into my hand also have it is my left foot. Now I am worse than I first got it. I have been to 12 damn different doctors in Spokane. They just take me off all meds.It people like you that can live a normal life and dont care that people do have chronic pain. You will never go to bed at night crying yourself and people around get anger cause they cant help. Just because some parents are keep there an eye on their own kids. You will be leaving people like me no way out but suicide!!!!!! We are people that abuse these type of meds!!!!!YOU PEOPLE SHOULD START THINKING ABOUT OTHER PEOPLE THAT DONT KNOW IFTHEY CAN GO ON DAY WITH FOR THE REST THEIR LIVES WITH PAIN!!!!!!!!!!!!!! I am writing to comment on the FDA regulating use of opioid drugs.  For people, including myself, who are in chronic pain, the use of opioid drugs is not an option.  There are days when it might not be necessary but most days and especially a flare-up of the conditions I have the only way to function is with these drugs.  If I had a choice, I would not take them or be in pain everyday of my life.  I would not miss family gatherings, work, getting together with friends, lose friends who no longer can understand why I cant go anywhere.  For some of us there is no option and whether or not we like it this is our reality.  Opioid drugs make us feel somewhat normal and somewhat able to function.  It does not make things go away just manageable for a while.  If you or someone in your family suffered from a chronic, life-long pain condition, I wonder if this would be an issue.  Please consider the millions of people this would affect.  We are not drug addicts, we are drug users that go through our doctors to get the help we need.  Thank you for your consideration.   Impact of Approved Drug Labeling on Chronic Opioid Therapy.  I would like to comment on this because I do have Fibromyalgia and if it were not for the Hydrocodone that I take, I would be in terrible, excruciating pain. My doctor has already told me that I am the worse case of Fibromyalgia that he has seen. The Hydrocodone doesnt even take away all of the pain, but it does take off the edge so it isnt so intense. This is why I do not believe in this new drug labeling. No, I am not an addict, I can go without the Hydrocodone, but it would be quite painful to do so. Please do not approve this new drug labeling. Im sure I am not the only one out here dealing with this problem.  Pain medications can be and in most cases is necessary for a person to have a nomal life.  Every persons pain level and tolorence is different and WHO has the right to say what you should and should not take.  If there is a medication that helps you control and frees you of pain (which if one has never had a cronic condition requiring this) then it should be allow for ANYONE to be able to get the medication when prescribed by a Physcian or Nurse.Not all medications work the same way for everyone I was on a medication for years that helped me lead a normal life under controlled pain medication and now because of someone or a group of someones I am in constant pain and have been since my Doctor can no longer prescribe the medication I need to live a semi normal life.  My pain will never be totally gone but the difference between being completely bed ridden and living a semi normal life that allows a person to function should be a choice that my Doctor and myself make, Not a group of people who have never been in a situation where pain is a everyday problem to having a life that most people live.  Contast pain causes severe depression and in my case not moving my body helps prevent the pain to a small degree compared to being on the pain medication which helped me and allowed me to move about more freely and enjoy life as much as possible.  Until you are in a situation yourself where you experience this I dont believe that anyone should have the right to say whether a medication of any kind should be limited or not be allowed.  Spend a day in the shoes of someone in chronic pain for just one day and experience the suffering and depression that it causes then think again about whether medication should be allowed to help make a major change in a persons life.Thank you for the chance to express my opinion in hope of concideration and a chance to once again have a major life change, to start living again and to love again.SincerelyMary Beams The PROPs recommendation of a maximum duration for continuous opioid treatment is a serious concern to those who legitimately suffer from chronic pain. I am a young adult living with Trigeminal Neuralgia (TN), also referred to as the Suicide Disease. Living the past 17 years with TN has stripped away my dreams and ruined my quality of life. I have been prescribed over 45 non-narcotic meds in attempt to manage my pain. These meds have resulted in the most awful side-effects.I have found on-going treatment with narcotic pain meds to be a life-saver for me. I have been taking narcotic pain meds for 10 years with mild side effects and little negative impact on my life. I have never taken them at a different dose or method than my doctor has instructed. I only take them to treat my constant and debilitating nerve pain in order to achieve more out of life  including maintaining my career, my independence, some quality of life, and basic survival. TN is a disease that becomes progressively worse over time. The last time my treatment did not include pain medication, I was so disabled that I could not work, care for myself independently, or perform basic ADLs. I could not eat, talk, brush my teeth, smile, or withstand a summer breeze without excruciating pain. I fully believe that I would NOT BE ALIVE TODAY if it hadnt been for the narcotic pain management treatment my doctor began a decade ago. What is 90 days of pain relief out of a lifetime of constant, debilitating pain? How can the PROP be allowed to decide who must suffer to death and who can be relieved of their pain? Why make the chronic pain patient who has a chance to live, succeed, and participate in life again, suffer needlessly when there are reliable treatments that work? Setting a maximum duration for opioid treatment will prevent chronic pain sufferers from receiving the medical care they need to survive.   