FDA Ratchets Up Heat On Opioid Prescriptions

FDA Ratchets Up Heat On Opioid Prescriptions

By Ed Coghlan

The U.S. Food and Drug Administration continues to increase the pressure on the prescription of opioids. It said Tuesday that all fast-acting opioid pain medicines will be required to carry its strongest warning about risks, including the risks for abuse, addiction, overdose and death.

“This epidemic touches all corners of our nation and is devastating individual lives, communities and our nation,” said FDA Commissioner Robert Califf during a briefing for reporters. He called the epidemic the “most urgent and devastating public health crisis facing our nation.”

More than 200 fast-acting versions of opioids, such as oxycodone, hydrocodone and morphine, have been targeted.  Ninety percent of all opioid prescriptions are for these fast-acting, or immediate-release, formulations.

The so-called “Black-box” warnings are the toughest the agency can require. Prescribing physicians tend to pay attention to these warnings.

The FDA wants to warn doctors and patients about the dangers of the drugs while ensuring they remain available for patients who need them to alleviate pain. However, Califf stressed the drugs should be reserved for severe pain for which no alternatives are available.

When taken with antidepressants and migraine medications, opioids can also cause a potentially life-threatening central nervous system condition known as serotonin syndrome, which occurs when the body is overloaded with the brain chemical serotonin.

Earlier this month, The  Centers for Disease Control and Prevention (CDC) announced new voluntary guidelines for medical professionals about when and how much opioid medication is appropriate to prescribe for chronic pain. Here’s a National Pain Report story on the CDC guideline.

While acknowledging that opioids are often prescribed to combat chronic pain, the agency said the risks far outweigh the benefits for most patients with long-term pain, except for those receiving cancer treatment or end-of-life care.

“More than 40 Americans die each day from prescription opioid overdoses, we must act now,” said CDC Director Tom Frieden, M.D., M.P.H. “Overprescribing opioids - largely for chronic pain - is a key driver of America’s drug-overdose epidemic. The guideline will give physicians and patients the information they need to make more informed decisions about treatment.”

The FDA announcement today tells chronic pain patients that the government’s emphasis is on addiction, not on chronic pain treatment.

It reads: “Today’s actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.”

Here’s the FDA press release.

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Authored by: Ed Coghlan

There are 17 comments for this article
  1. Tim Mason at 6:57 pm

    Also note that the CDC receives grant money to do studies and publish articles. This is money that keeps them employed. This money comes from many sources including drug companies. I recently attended a talk held by a CDC researcher about antibiotics and such. He mentioned grants the work being done and questions were taken from the audience.
    This may be considered off topic but not quite. Recent research by CDC shows that Statins are being misused. They were not intended to be used for moderate cholesterol levels but they are. In fact people are falling ill every day but you will not see this information published because the drug companies that make, promote and sell statins have a great deal of money to lose. I presume that dollars going to fund PR by CDC are driving the anti-opioid craze. Just think of the medical manufactures promoting the medical devices like spinal stimulators and such. The drug companies and drug device manufactures are in bed together. (so to speak)

  2. Cerys at 11:29 am

    We need a black-box warning on bureaucratic interference with healthCARE. The same people who dismiss debilitating pain syndromes elevate the erroneous definition of addiction as a disease state. It is not. Let individualized treatment prevail.

  3. Monica Demers at 10:48 am

    1 small points…. that’s all the energy I have, and the people that need to will not listen anyway.

    1: When will the FDA and the GOV. UNDERSTAND the DIFFERENCE between ADDICTED and DEPENDANT ??? Is it that hard to wrap your mind around, do you not all have substantial collegiate degrees. ? ( If any of you need help with this I would be happy to explain )

  4. Dave at 7:28 am

    Its the great costs associated with pain care- and especially opioids that the Federal government is targeting. Their equation is less access to opioids= less diversion= less costs. What’s missing in the equation is cost of pain care without opioids, the cost of disability without opioids, the costs of suicide without opioids, the human costs in terms of suffering without opioids.
    But its people in pain, who for too long have allowed medicine and government to be too free to do as they please with regard to their well- being-that have been made into serfs.Now government shows its true colors about how much they don’t care about the costs in terms of suffering to people in pain.
    Unfortunately people in pain will continue to suffer, curse the darkness, allow medicine and government to treat them- or should I say mistreat them- and do too little to change their fate. And people in pain will wear their suffering like a thorny crown long after medicine and government have planted their victory flag on pain care in America.

  5. Kerry McKelvey at 8:42 pm

    Why isn’t alcohol taken out of grocery stores or carefully handed out to people who will never have a medical need for its part in these overdoses? I don’t know where they could have possibly gotten any studies about the adrenal insufficiency or hormone imbalances because those are also caused by untreated and under treated pain also! I have no pituitary yet I’ve had doctors try to argue these facts with me. Everybody with ongoing severe chronic pain needs to be assessed for these endocrine responses to their stress response system but we have only a few Pain Management Specialists left in this country because they all became pill counters the minute they chose to loose their common sense and compassion by not sticking together to fight for their patients and slough off their hardest hit patients to the ones who bravely stood their ground and risked everything they worked hard for by treating us. These aren’t even facts in their “report”. I don’t know how they sleep at night!

  6. Lisa Davis Budzinski at 6:13 pm

    But where is the teaching teens and 20yr + who are ODing from street bought opioids? These make up the true stats for opioid deaths per day. I’ve seen it for over 20 years working at the State Attorney’s Office.

    Lisa Davis Budzinski
    VP of CPSFoundation
    Ambassador for US Pain
    Delegate for Power of Pain
    Stroke survivor
    Cancer survivor

  7. Angie Heavner at 5:47 pm

    I have tried to stay quiet about this and keep a close watch on which way this was heading. Now I can no longer stand back. Its been 5 yrs since I have lost the use of my right hand and arm. This was due to a hospital screw up that has cost me my life. I now live with whats known as the worst chronic pain condition on record Complex Regional Pain Syndrome. Funny thing is its been around since the civil war and I have never heard of it til I got it, and I was in nursing. I went from not being able to take benadryl without sleeping for 8 hrs to nothing helps me sleep. The meds I am on now are down to the few I haven’t had allergic reactions to, yet now I am being told those I can’t have because I don’t have cancer. You guys all need to reevaluate what you are doing and thinking. Drug addiction is HERION not prescriptions. Its meth, coke, crack and what ever else they can get their hands on. The government started the herion problem and that is where it needs to stay.
    Live a week in an Honest Chronic Pain Patient and there is a huge difference. I wish I could live without meds, and sleep, go outside and enjoy the weather no matter what it is. I can’t. My life was taken from me because of a screw up and my medications allow me to function from day to day. Some days I don’t even do that.

  8. Andrew Sikorski Psychiatric RN Ret. at 1:48 pm

    Now before some get all excited let us take a look at one of many many other studies by the CDC which is not quite up to date but will be shortly. I always look at what is trying to ne put across to me and why these or those that want to lobby for me to have me side with them for one thing or another in their favor we, you and me are the ones that in the end are getting screwed… that is the short of it and yes, the pun was intended. Put your egos back into you pants and look at what the other evidence is first before you get groggy and jumpy cause you just might lose… again… Then again there is this article that states… FDA announces enhanced warnings for immediate-release opioid pain medications related to risks of misuse, abuse, addiction, overdose and death and t hi article… https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm491739.htm as far as I am concerned there are time and places that immediate released opioid meds are a life saver… when nothing else works they are the first line of defense that any patient has so a small degree of comfort. For those of you who have never suffered for years at a time with this debilitating pain do not say a word because you have not one idea of what we who do have to endure and that is just to stay alive and that is on a daily basis and has not one thing to do with any drug but has everything to do with the hypocrisy of those that govern and act like the lords of the universe of which they are not and one day when all that cr*p comes tumbling down around their ankles will soon realize..!

  9. susan bowie at 12:44 pm

    I have multiple sclerosis. Sarcodsis and a back fusion. I am disabled. Need (unfortunately pain meds)

  10. Jeremy Goodwin, MS, MD at 10:50 am

    I have prescribed opioids very carefully abd with monitoring and risk assessment for over two decades to countless patients in a pain medicine practice both in an academic and a private setting. I do not recall a single patient accidently overdosing. Furthermore many have been on antidepressants without even a hint of serotonin syndrome. Cannabis alone or with opioids has worked at tomes and not others but never have I seen a worrisome interaction between the two.

    These are all being trumped up to shore up a political move that was ignored when those hooked on opioids were mostly black. Suddenly tgere is huge concern giving thise who do not wish to manage pain at all a great excuse to bow out when alternatives to opioids fail. And yes, there has long been a need for better education of medical students and clinicians in interdusciplinary care ( not to mention a need for better insurance coverage of it) and prescription practices, but not one such as this draconian patient harming overreaction. It is mostly political.

    About 35 die every day from guns in the USA. What is being done about that?

  11. Jane at 9:41 am

    As a 3 year patient of CRPS, NOBODY could possibly understand the degree of pain that is associated with this chronic pain or other types of chronic pain that is not associated with cancer! With my medication, I get to live a somewhat normal life. I get to keep my job, I get to take care of my elderly mother, I get to go to church and still can do limited physical activities to a little degree. Gone…is my ability to play, hike, jog, or anything that requires alot of movement and agility and to sleep a full night without waking in horrible stabbing pain. But, with my VERY MANAGED medications, I can still live a life that is worth living. I’m not an abuser, I am a survivor, it is not US that you should worry about, let Doctors do their jobs. Without my medication, my life would be UNBEARABLE, I could not tolerate participating in any normal form of life. Please, LISTEN to US!! Don’t sit on your throne and dictate things that you are CLUELESS to!!! Please listen to real people with REAL PAIN, PLEASE!

  12. mike at 9:05 am

    “The FDA announcement today tells chronic pain patients that the government’s emphasis is on addiction, not on chronic pain treatment.”

    What does this sentence even mean? By their definition, we’re all addicts.

  13. BL at 8:24 am

    “It reads: “Today’s actions are among a number of steps the agency recently outlined in a plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.”” Many will think that this statement says that opioids will still be readily available for those with chronic non cancer or terminal related pain. But, you have read between the lines and looked at what is not said and shared that with your readers.

    “While acknowledging that opioids are often prescribed to combat chronic pain, the agency said the risks far outweigh the benefits for most patients with long-term pain, except for those receiving cancer treatment or end-of-life care.”

    “The FDA announcement today tells chronic pain patients that the government’s emphasis is on addiction, not on chronic pain treatment.”

  14. Elton L. at 6:54 am

    Opioid medications to chronic passion patients such as myself, depend on their pain medications to at least have a better quality of life. And really, nothing on earth deserve to suffer from chronic pain. To those who really don’t understand patients like myself and the many of us that can’t even take their kids to the park or carry their youngest little girl on their back, and that’s something that a proud father loves to do but I can’t and barely can get out of bed everyday. My pain is relentless and is 24 hours a day ,7 days a week and 365 daddy’s of the year. So as I was saying before I started rambling on that it’s not the doctor’s fault, the company the medicate comes from nor the billions of us that suffers everyday with pain. It’s the person that goes and take way more than prescribed. I understand that I will never be pain-free but just as long as I can continue with my pain meds ,I’ll just keep moving right along.

  15. TIm Mason at 4:16 am

    “Overprescribing opioids – largely for chronic pain – is a key driver of America’s drug-overdose epidemic”.
    I have read several articles written by people that have researched addiction. The largest risk to addiction and overdose is youth. Very few chronic pain patients show up at Emergency rooms for overdose. Seventy five percent of recreational opioid users in 2013-14 got pills from sources other than doctors, mainly friends and relatives. either stole the medication or bought it from someone that stole it. Many of these users among this group, moving on to heroin is quite rare: 0.2 % of US adults are heroin users.
    The proportion of patients who become newly addicted to opioid medication during pain treatment is also low. The Cochrane review (the gold standard for basing medical practice on evidence found an addiction rate of less than 1%)
    source: Washington Post, “Five Myths about Heroin”, Maria Szalavitz, March 4, 2016

  16. Doc Anonymous at 3:11 am

    I have no problem putting this warning on ALL opioids. I am surprised that it has not been there in the past, but that probably reflects the FDAs lackadaisical approach to pain patients. The fact is that these medicines CAN cause death and that should be clearly noted. But it should be up to the doctor and the patient to make the decisions about initiation and continuation of treatment. Unfortunately the FDA to date has participated in a hysteria driven effort to restrict the treatment of one class of patients (those with chronic incurable pain) rather than manage the optimal use of the medication itself.

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