Tramadol to become Schedule IV controlled substance

Addendum 7/3/2014: Updated to include information on prescribing and recordkeeping requirements.*

Today the Drug Enforcement Administration (DEA) published its decision to schedule tramadol as a Schedule IV controlled substance. The rule becomes effective August 18 of this year. The DEA’s action was fairly swift, having published its proposal to schedule tramadol just eight months ago (see blog post from November 2013). Upon conducting its eight-step analysis, the DEA found that relative to Schedule III drugs, tramadol has a low potential for abuse and limited physical dependence, and coupled with tramadol’s medical legitimacy, DEA determined Schedule IV to be the most fitting for tramadol.

In its final rule, DEA recognized the use of tramadol and other tramadol-containing products for management of moderate to moderately severe pain. It also defines tramadol as an ‘‘opiate’’ which means DEA believes tramadol is capable of triggering addictions similar to morphine. In veterinary medicine, tramadol has been used in pain control protocols, especially in dogs and cats.

So what does this mean for veterinarians who regularly utilize tramadol in their practices? In some cases, drug-label mandates could cause disruptions in commercial availability. Conversely for tramadol, its scheduling is expected to be helpful from a distribution standpoint, as current differences across state rules have reportedly been logistically challenging for veterinary distributors. In fact, in January of this year, the American Veterinary Distributors Association indicated its support for DEA’s consideration to schedule tramadol, in part, because distributors will be able to operate more efficiently and consistently nationwide.The DEA provided for a slightly extended 45-day window of time for drug sponsors to incorporate a “C-IV” on the label, and for distributors to deplete their current stocks of non-controlled tramadol. As of August 18, containers of tramadol will be labeled with a “C-IV” and all applicable DEA requirements will apply. Remember also to follow state rules, which might be more stringent.

*Tramadol’s scheduling also means that veterinarians who do not have a DEA registration number will not be able to prescribe tramadol nationwide, effective August 18. (Administration and dispensing from the clinic can still be done by non-DEA registrant veterinarians if acting as authorized agents.) Recall that for veterinarians who do have a DEA registration number, Schedule IV substances can be prescribed via written prescription, fax, or call, if acceptable within state rules. Limited refills are acceptable for Schedule IV substances. Biennial inventory and recordkeeping requirements for Schedules III-V also will apply for tramadol. Check DEA’s rules for full details.

For more information on how to comply with DEA rules, see AVMA’s Veterinary Compliance with the Controlled Substances Act and the DEA (member login required) for more detailed information about DEA registration, and and recordkeeping requirements.

39 thoughts on “Tramadol to become Schedule IV controlled substance

  1. While this drug is not a classic opioid, it does work on the opioid receptors and has a low affinity for opioid receptors, and the M1 metabolite of tramadol, produced by liver O-demethylation, shows a higher affinity for opioid receptors than the parent drug. I worked for a vet who was taking this stuff like candy. He was going through a large bottle of it every few weeks, 300 milligrams a hit, 6 tablets at a time, 3 times a day as he told me. I’d bet it was even more than what he admitted to. He was on a number of other medications for fibromyalgia and depression as well. Unfortunately, he took his own life about 5 years ago.

    My own experience with it has been good, but I also experienced the antidepressant properties which made me wary. Thus, I limit myself to only one 50-mg. tablet per day for a chronic knee injury, and couple it with ibuprofen, which extends the effective benefit. Thus, my pain is well-managed and I don’t need a lot of either drug because they synergistic effects are so good and long-lasting in my case.

    However, I should not be taking ANY NSAID because of an aspirin allergy. I do so knowing the risk, and use only the smallest dose along with the tramadol in order to minimize adverse effects from either drug. But I hate traditional opiates and refuse to take them. Tylenol does not work for me with pain at all, never has, and the risk to the liver is not acceptable. My liver is compromised from another medication in my past, so I try to avoid anything that requires heavy liver processing. The line between effective and toxic with Tylenol is so fine that I don’t consider it safe in my case, and the damage in my knee is so severe that even my own doctor has said that Tylenol would be almost useless. He was correct. I’ve already had too many cortisone shots, so those are out. I’m in physical therapy of sorts and doing everything else that is recommended to deal with this knee, but there is and always will be pain until the joint is totally replaced, and I’m too young for that. So now, my last safety net is all but gone. The only viable option now for long-term relief is surgery, or medical cannabis which is not legal on the federal level or on the state level in my state. Therefore, I’m pretty bummed that tramadol is now a scheduled drug. I’m out of options.

    • You bring up an excellent point. I am a pharmacologist and I know that tamadol when combined with acetaminophen (Tylenol) makes it exponentially more effective at controlling pain. However, not being able to take NSAIDs makes your condition a special case that cannot be generalized to the general population. While is does partially bind to mu-opiod receptors, when taken as prescribed, (generally 50 mg tid), your withdrawal symptoms from the drug are not due to classical opiate withdrawals. It simply does not sufficiently bind to mu-opiod receptors enough to cause opiate withdrawal symptoms such as those you would experience when suddenly discontinuing oxycodone or hydrocodone containing drugs. Tramadol’s primary analgesic effects are due to the COMBINATION of its partial mu-opiod recptor binding AND its significant serotonin and norepinephrin reuptake inhibiting (SNRI) effects. Drugs such as cymbalta and effexor are SNRIs. The withdrawal symptoms people experience when suddenly discontinuing tramadol (assuming you take it as prescribed) are due to SNRI withdrawl, similar to what you would experience with cymbalta or effexor when taking it as prescribed and discontinuing it abruptly.. Therefore, my question is, why is tramadol now controlled (which according to the DEA is for our own good due to its potential for dependence and withdrawal), why are antidepressants not controlled as well? Furthermore, alcohol and tobacco are uncontrolled despite fitting the schedule 1 criteria (high potential for abuse and dependence, no legitimate medical use, and There is a lack of accepted safety for use of the drug or other substance under medical supervision), and marijuana is a schedule 1 drug despite NOT fitting the criteria for that schedule.. Problems like this will continue to arise unless the United State’s incredibly outdated controlled substances act (which is 44 years old) is completely revamped and the DEA does its job by enforcing drug-related laws: NOT making decisions about which drugs should be controlled substances when pharmacologists, medical research experts, and psychiatrists are the ones with the intricate knowledge of the effects of psychoactive . Thoughts?

  2. Do dogs experience withdrawal after being given Tramadol for a while? I came to read this article because recently one of my elderly dogs was prescribed Tramadol, which he had had before as had a couple other dogs. I was asked by my vets’ staff to sign a form and was surprised, as I never had been before. So it’s now a controlled substance. What I find most interesting is the number of comments here regarding human use, particularly withdrawal. Does anyone know if dogs get withdrawal symptoms, too?

  3. I agree with the last couple comments. Tramadol does help with pain, but when you run out, the withdraws are crazy. I’ve been on vicodin, percocets, pain shots. Never experienced any withdrawal symptoms like tramadol. I have flu like symptoms, and get cpold chills, hot flashes. Not to mention I become very sad and irritated. I’ve always considered myself a very strong person. If I was able to get off all those other pain meds I can get off tramadol as well. The problem is; I don’t need to get off tramadol. I have RA in my right arm neck and back tramadol really helps with the pain especially when I’m at work. The problem is the withdraws. I haven’t told my Dr yet. I will be letting him know at my next appointment.

  4. My husband has been taking Tramadol for 15 years and when he tried to refill it today the pharmacy said it was a controlled substance and the doctor would not allow the refill. I thought that after that many years that you would have to be walked off a drug like this slowly. I have read on the withdraw symptoms and from what I see it looks like a lawsuit may be in the near future. He did not even issue him a new pain medication for his back.He is completely disabled because of his back.

  5. I am 9 years clean of any opiates, I can tell you when you are constantly living in pain, You’ll understand a Little bit more as to why people are prescribed Tramadol. First Tramadol has saved my life I have flattening of the spinal cord, Encroachment of discs along with many issues, I’m just 35 years old living in CHRONIC PAIN. I am a Paralegal love my job and wouldn’t quit for the world. Anotherwords I will not lay down and die.

    I dont want Percocet, Vicodin, Oxycotin, SO WHAT ELSE CAN WE TAKE.

    DEA stop hurting people like myself who don’t abuse Thank You.

  6. This is another example of the feds pretending to be relavent. I was moved to tramadol presisely to avoid these issues the DEA over reporting. They can’t win the illegal drug war so the created a new fame of name the bad drug. Tramadol is not only nearly impossible to become addicted too but sucks at pain control compared to its natural opiate cousins which btw are rarely addictive when prescribed by a doctor and the patient sticks to the instructions. One more moment of Obama’s failed regime trying to run one more aspect of my life.

  7. I’ve had my share of opiates. While tramadol is not an opiate if you take enough it will get you high and can be addicting when you run out of it after taking it for a period of time. You’ll just want to lie in bed all day and not move and deal with restless leg system because your muscles are twitching. Also tramadol has a negative interaction with a TON of other medications out there when they are mixed together. I agree it should be a scheduled substance and should be monitored closely. No more picking it up 2 weeks early like i used to be able to :(

    • Dosent mean because you just to pick them up two weeks early everyone is the same. I use them for neurophaty now my PCP went down on my dose that the neurology had game me and im the one suffering. If you dont know was neurophaty look it up i dont even wich that to my worse enemy.

  8. I was recently speaking to a compound pharmacy in New Hampshire. The state of New Hampshire is limiting the dispense of tramadol 50 mg to a 1 week supply. for veterinary hospitals and a 1 month supply for compounding pharmacies. Trying to find regulations of dispensing Tramadol in veterinary hospitals in Massachusetts. Anyone?

  9. If we still have unmarked/uncontrolled bottles of Tramadol after August 18th, we don’t have to start reporting until we start using the re-labled product, correct?

    • Kerry, in its final rule, the DEA indicates that as of August 18, registrants handling tramadol must follow all the DEA requirements in place for Schedule IV substances, including inventories, prescriptions, security, and recordkeeping. The DEA gave 45 days’ notice to help dwindle the currently available supply (e.g., pre-scheduling, non-controlled label supply) down while manufacturers re-label the products reflecting tramadol’s new controlled substance status. The DEA’s expectations are that distributors will only be selling tramadol labeled “C-IV” on and after August 18, 2014. Also check with your state on its specific requirements for reporting tramadol and other controlled substances. Some states require veterinarians to report to the state prescription monitoring program while others exempt veterinarians or have different requirements. Since prescription drug monitoring varies by state, the National Association of State Controlled Substance Authorities (http://www.nascsa.org/statecontacts.htm) also might be a helpful resource for you regarding reporting of controlled substances.

  10. Does anyone know of a safe way to come off of this drug? I have been taking for 2 yrs. and when I try to come off I become highly irritated, restless and anxiety levels are extremely high! I take responsibility for my part in my taking this when I was fresh out of treatment, however I was completely honest with my doctor about my addiction and she still prescribe it. I want off

    • Brenda, It depends on how much you are taking. The safest way to come off Tramadol is to reduce your intake gradually until you are down to two pills per day, assuming you are taking 50mg per dose. Once you are down to the two doses, take one dose and only one dose each morning for three days. Do not give in to that voice in your head that tells you to take more. After 3 or 4 days reduce your intake to zero. The withdrawal is brutal. You will want to take more, but you have to be strong and ignore those urges. Once you stop taking the drug altogether, you will feel quite ill for about a week. The nausea will lessen over time and within 10 days or so you will start to feel like your old self before you got hooked on this drug. Remember to drink plenty of fluids. Force yourself to eat. Room temperature ginger ale will help with the queasy stomach. Good luck and remember, be strong.

    • The best way to get off the drug is to have your doctor wean you off of it.
      I think that first take 3 a day for 8 days, then drop down to 2 a day and then
      to 1 a day for 7 days and STOP. That should safely get you off. Good luck.
      MG

  11. Pingback: Tramadol - now a controlled substance - YorkieTalk.com Forums - Yorkshire Terrier Community

  12. Every hospital I have worked at within the last 5 years has treated this drug as a controlled substance. It gets abused, bottom line. This has been needed for a while. The transition was not that difficult and actually uncovered a couple employees who were abusing these drugs.

    • Mark Really? Do you suffer from Chronic Pain and refuse Methadone, Percocet, Oxycontin, Vicodin?
      If not I think you should be a little more compassionate to those like myself, I will be an Attorney someday most likely would be in a wheelchair if it weren’t for Tramadol.

      Incompassionate is all I can Say.

      • Incompassionate? I am a disabled Army veteran as well as a CVT. Tramadol is dangerous and this has long been needed. I was on Tramadol for 6 straight years to cope with my injuries, and it is VERY easy to abuse. Tolerance goes up extremely fast and it severely screws with your serotonin levels and psychological state. The withdrawals coming off Tramadol are more brutal than even heroin — this I know from the dozens of other Tramadol addicts I’ve come to know, some of whom had heroin addictions prior to enlisting. Heroin withdrawal is over within 7-10 days. Tramadol withdrawal lasts MONTHS. Vomiting, diarrhea, chills, sweats, joint pain, muscle pain, your original pain amplified 100x, restless legs unlike anything you’ve ever felt in your life, and severe anxiety/depression. I tried going cold-turkey many times, and could never last a week because withdrawals are so bad. I finally had to get into a drug treatment program and get on SubOxone (buprenorphine), and that is the only thing that saved me. A year and a half later, I STILL require 2mg of SubOxone daily because I STILL have Tramadol withdrawal effects. Undoing 6 years on that drug is gonna take 2-2.5 years. You couldn’t pay me to get back on it, nor anyone else I know that has gotten off it. We’d rather live with missing limbs, missing eyes, crushed vertebra, fractured pelvises, etc. than take Tramadol again. Makes you wonder what our non-human patients go through when taken off Tramadol?

        Tonya, if you have a legitimate licensed physician that monitors your case, and a legitimate need for Tramadol to control your pain, then you will have no problem getting your medication prescribed from your doctor. No different than before. This new classification only affects those abusing the non-controlled nature and ordering it from online pharmacies 180 pills at a time, or getting it prescribed by their doctor without the MD giving it a second thought, or easily making up excuses to get it OTC from their DVM. This creates awareness of the serious abuse potential, tolerance, and withdrawals so that physicians can better monitor and better help their patients.

      • I have taken EVERY single opiate known to man and for many years due to chronic pain in back and neck but for the past 10 years taken Tramadol only…..I have NEVER had ANY issues not taking it once my script has run out or I missed an appointment due to being on the road!!! This move by the DEA is about as absurd as their war on drugs has been!?! NON narcotic means EXACTLY that….no matter what anyone says or how it works!! No way this should be called a controlled substance, period!! More signs that the idiots in charge have NO clue whatsoever!?! I have NEVER experienced any high from this med like I did SO many times while on ACTUAL narcotics!!!

  13. This will not change our ability to treat pets with Tramadol. The only thing it changes is that the drug will have to be locked up like other controlled substances, you have to log the drug inventory, and you need a DEA registration to purchase or prescribe the drug. As veterinarians, we need to be responsible keepers of drugs and prevent diversion. There are multiple instances I have heard of Tramadol seekers coming to veterinarians offices.

    I know many veterinarians, myself included, that have treated this drug as controlled for quite some time in anticipation of this move as well as to prevent diversion/abuse. We keep it locked up and keep a log of inventory and clients who are dispensed. Many states already have classified this as a controlled substance.

    Fred

  14. I wanted to take a moment to share the Final Rule published by the DEA (http://www.gpo.gov/fdsys/pkg/FR-2014-07-02/pdf/2014-15548.pdf), where you can find many more details. For example, DEA responds to questions about the impact of the scheduling in areas of human medicine. Likewise, DEA discusses its definition of “opiate” and why/how it arrived at its scheduling determination for tramadol (especially page 37626). Hopefully this is helpful context to those interested in reading more about DEA’s analysis.

    Thanks to all for the feedback on this issue. As Dr. Gingrich pointed out, some veterinarians are already treating tramadol as a CS (either voluntarily, or mandated by state rules). For those who aren’t, we want to do our best to spread the word about DEA’s action so veterinarians are informed and prepared.

  15. This article is about reclassifyingbit for veterinary usage only. It has already been a Schedule IV for a while now for human consumption/usage.

    http://en.m.wikipedia.org/wiki/Tramadol Scroll down slowly and check the “legal status” for US. Schedule 4’s are allowed refills, and all the perks of normal scripts, they just have to keep an eye on them a bit closer. (Been there, done that).

    • You couldn’t possibly be more wrong. This drug damn near ruined my life, and the withdraw from this drug was much worse than any other pain pill I had ever taken. Thankfully that is all in my past. But this drug is dangerous.

        • On this drug for 2 yrs. 5x50mg tablets a day was told because of my alcohol add. it would be safe and no worry of cross add. with opiates! Sometimes I think they should make Drs. take the same pills they prescribe to us, then they will know what the hell their talking about! Coming off Tramadol withdrawal was hell I felt sicker more than any other time I had the flu! Would not wish this on anybody! Checked myself into treatment and 4 other individuals said the same thing. Two of them were former Heroin add. and they said the same thing as well!

    • tramadol is very addictive! i have had five surgeries on both knees, and was given tramadol. i was fighting a bit of depression from being unemployed because i can no longer function at my job after having my fifth surgery, i was put back on tramadol. amazingly my depression went away. it turns out that tramadol has a snri in it which is a drug given for depression. i told my doc about how well it helped my depression, so he wrote me a script for it for my depression. i went through hell after stopping it. it seems the added snri makes withdrawal harder in some cases than plain opiates. so be careful

      • All I can say is bull**** ,it was the only thing I could have that gave me a fighting chance for any kind of life. Getting off it was as easy as any other narcotic. 3 to 4 days of hell, then right back to the acute and chronic pain. I am 55 years old and have been on pain control since 1982, my first surgery,as it stands pain has taken every thing that makes life worth living.

    • Pinky, I agree with you, this is the Fed’s new way of playing stupid head games. Lets focus on the troops that die everyday because we help other countries. Cmon People THIS IS NOT DOPE.

      Thanks,

    • Oh yes it is!!! I ran out early and felt like I was in hell from the withdrawals, and it last five days until I got a new prescription. The worse I’ve ever been thru. It’s a demon drug! I feel like suing someone as I had asked from something non narcotic.

  16. So, does this mean I can’t work in the vet tech field if I’m taking it myself for my own health needs? This is pure nonsense. It isn’t even MADE using the same ingredients!

  17. This is so wrong. It is not an opiate. It is not a
    contrOiled substance for humans. Get real

  18. Absurd. I have old arthritic dogs who are still able to walk thanks to Tramadol.

    The FDA is in collusion with the pharmaceutical companies and insurance companies, and is not working for the American people. Time to change that or stop funding them.

  19. Although this will require more record keeping on the part of the veterinarian, I am supportive of scheduling this drug. Our practice has been treating tramadol as a CS for a couple years to demonstrate to staff that this is a drug we need to closely monitor and log as well as having good records similar to what is required for CS. It will also be easier to have all states have the same regulations on this drug.

    Fred