Request that the FDA immediately seek removal of oral and transmucosal UHDU opioid analgesics from the market
Citizen Petition Changes in Opioid Prescribing in the US American College of Medical Toxicology National Safety Council Assoc of State and Territorial Health Officals Centers for Disease Control and Prevention American Academy of Pain Medicine American Pain Society UHDU Opioid Analgesics OxyContin 80 milligram tablet oxycodone UHDU opioids CDC Guideline fatal overdose 50–100MME 20 MME opioid use disorder
2017-10-18 2017-09-07 2017-11-17 2017-11-17 2017-11-24 2018-09-12 2018-01-02 2018-09-12 2018-09-12 2018-09-12
FDA-2017-P-5396-0138 FDA-2017-P-5396-0006 FDA-2017-P-5396-0326 FDA-2017-P-5396-0341 FDA-2017-P-5396-0405 FDA-2017-P-5396-1631 FDA-2017-P-5396-0569 FDA-2017-P-5396-1636 FDA-2017-P-5396-1633 FDA-2017-P-5396-1627
04:00:00 04:00:00 05:00:00 05:00:00 05:00:00 04:00:00 05:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2017-P-5396-0138 https://api.regulations.gov/v4/comments/FDA-2017-P-5396-0006 https://api.regulations.gov/v4/comments/FDA-2017-P-5396-0326 https://api.regulations.gov/v4/comments/FDA-2017-P-5396-0341 https://api.regulations.gov/v4/comments/FDA-2017-P-5396-0405 https://api.regulations.gov/v4/comments/FDA-2017-P-5396-1631 https://api.regulations.gov/v4/comments/FDA-2017-P-5396-0569 https://api.regulations.gov/v4/comments/FDA-2017-P-5396-1636 https://api.regulations.gov/v4/comments/FDA-2017-P-5396-1633 https://api.regulations.gov/v4/comments/FDA-2017-P-5396-1627
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous Anonymous
I am writing for my husband who is in too much pain to form sentences. He has been removed from his pain medication after 8 years with the same doctor. It is inhumane for the government to decide who is in pain and how much medication they need. Pain patients are committing suicide because they see no way out of the pain they have from failed surgeries AS, cancer,other diseases, end of life pain.Please think, if this was your family member, how would you feel if they were in excruciating intractable pain every day. The pain medication was working, they had a life, now they dont. They cant work any more or participate in life. Not only are they in pain but they are going through severe withdrawals.  Is this what the govt intended when it began to blame long term pain patients for the opioid crises? What about the fake fentanyl being manufactured in China? In Nebraska this week enough of this manufactured or fake fentanyl was found to kill 5M people. Is this the goal  Please, have compassion for those who are dying, in agony and cant take a pill.I have seen that prescriptions for narcotics are down by 70% while death from fentanyl has risen 110% Cant anyone see what is happening? This chart is from MD but I have read other states are the same. I do understand the misuse of opiates but I have been on IR Oxycodone as a Chronic Pain Patient there are risk of over takingmedication but as your report says this has been in the ages of 13 to 25 mainly and those ages are very low and the over doses very high. I could understand not wanting anyone in hose age groups not being on that many MME but the Older people that have had Chronic Pain for many years knows the risk to look for and when not to take the medication during those times. Our Government has going why to far trying to stop a street drug problem that has been going on for years in one year and forgetting about Chronic Pain that can not be fixed with surgery or therapy. Some of use had surgery and came out worse than when we had it from no fault of our own and now have no one who will take s own as patients because of the damage done from our first surgery where does that leave us? i even understand wanting to stop the 30 mg oxycodone but this is going to cause more pills to be dispensed at 20 mg. I feel 120 mme would be more realistic than 90 mme at the lower dose per 4 to 6 hours. Studies are showing that under treating pain is already contributing to the increase of over dose on heroin and fentanyl. The CDC ignored warnings that this would happen. Further restriction will have dire consequences for millions and society as a whole Too many rare disorders we know so little about because of limited research funding. Many cause chronic pain which leads to total disability if not properly treated.  Keep chronic pain people working  thriving in life instead of in bed on heating pad unable to concentrate. Pain causes accidents: i ran a red light because while driving, i couldnt concentrate  almost hit a car with kids in it. I did what dr told me - i got up  started moving, but pain will cause more deaths than drug addictions anyday of the week. Untreated pain kills in more ways than acknowledged by anyone. It is irresponsible and cruel to leave those in chronic pain without opioid medication. They are the most effective medications for chronic pain. Vote no on HR 6 so it will protect the chronic pain patients People suffer from multitude of diseases which can cause intractable pain/ chronic pain and their doctors do tests to arrive at a diagnosis so they can treat them. Its unconscionable that an organization whose name reveals their bias which was arrived at sadly because one of their children had addiction disease and died from overdose would repeatedly attempt to interfere in doctor patient relationship. Furthermore its absolutely incomprehensible that an org armed with the power of federal government would rather see disabled people suffer pain than admit their efforts are harming thousands if not millions of people. If you have a rodent in your yard are you going to blame your house cat? Statistics are proving the overdose increases are due to illegal street drugs, not prescriptions. This org would beat the house cat because the rodents in the yard are multiplying. If you do not identify the problem correctly all efforts to solve it will fail. Ive seen multiple accounts of surgeries, including hip replacements, being done but patients are not receiving pain rx. Has this county lost its mind? There is an old saying you can lead a horse to water but you cant make him drink. You can talk to an addict til youre blue in the face but if they. are not willing, you cant make them stop unless you lock them up. It took years for me to get a diagnosis of my autoimmune disease. It has affected all my bones and now my organs. My pain never ends and at times is comparable to child birth. If I was unable to have pain rx I would not be able to participate in daily activities. I cant even hold a phone because of pan and numbness in my hands, and this is the least of my challenges. Dont discount my life because someone else decided to try drugs and misuse them due to addiction receptor disease. I may be disabled but should not be discounted. Dont ban these meds and please stop harassing doctors who are trying to help people have some semblance of a normal life. You Really Need to stop reducing opioid meds because you Know as well as Anyone with Internet that its NOT prescribed opioid meds causing this! Its the Street Drugs including illicit and illegal drugs period! Ive dealt with degenerative disc disease, CRPS, fibromyalgia, raynauds disease and tachycardia. Because if all my health issues Ive had to search for medication and treatments that worked best for me. These health issues will never go away completely so I search for the best quality of life. Ive found the best combination for me is watch my diet, physical therapy, chiropractic care, stretching, pain medication and other treatments like stem cell injections. This combination is what works. Pain medication is essential in this combination so that I can get up daily and be productive running my internet talk show. Ive advocated for the chronic pain committed for over 2 years. What PROP is suggesting will not change the overdose numbers in the way you would think. It will cause overdose rates to go up, more suicides and people will develop other major health issues due to the effects one has in high levels of pain. Im an example of this. My doctor tapered me below the 90mme for over a year and I developed tachycardia due to thigher blood pressure and constant out of control pain. FDA please let doctors make the decision as to what each patient should have for medications and treatments.  As a pain patient I see more  more of the medications used to treat our disease, and yes chronic pain is a disease, being taken from us in the name of saving addicts. I come from a family of addicts and I have deep compassion for this horrendous disease but I do not think its treat should be done at the detriment of millions of others who suffer needlessly now that you have taken our pain medications away. I have tried to reach out to Mr. Kolodny only to be blocked by him on Twitter. We speak at hearings but it falls on deaf ears. The CDC openly admits to using improper data when coming up with PROP guidelines yet none of this matters to you. I have to ask myself why? Why are you slowly removing the tools that very capable intelligent doctors use to help people with legitimate pain. I can guarantee I tried every alternative treatment available. My bank records are proof of this. I am now broke from paying for these treatments. Neither me nor my friends want to be on pain medication but until our illnesses have a better safer treatment, you cannot deny opioids work, they are noninvasive, and are inexpensive. Have none if considered that you are only one accident, one fall away from being in our shoes? We are educated people who have a lot to give to society if only we could get out of bed. Are you aware that people are now canceling much needed surgeries because they fear not having pain control after their procedure. Mastectomies done without pain control. Open heart surgery; no pain control. I am sure you are well aware of the toll pain takes on the body in the form of increased heart rate, blood pressure, anxiety, adrenal stress. The list goes on. The worst of which is the decision that life is not worth living anymore when you must live each and every moment in pain. Yes, I am talking about choosing suicide over a daily struggle of missing out on being with your children, grandchildren, working, cleaning your home, loving your spouse, going to school, even just being able to walk to the bathroom. Why? Why must I see each day another regulation that denies help to those in pain? Are we worthless to society? I am beginning to believe the answer is yes.