Ultram, Ultracet Suicide And Overdose Warnings Added to Label After Deaths

feature photo

By: Staff Writers | Published: May 26th, 2010

The FDA is warning doctors not to prescribe the painkillers Ultram and Ultracet to patients who have shone themselves to be suicidal or vulnerable to addiction. 

The FDA announced on Tuesday that it is contraindicating the tramadol-based opioid painkillers Ultram and Ultracet for these users after reports of deaths and overdoses, and due to its ability to cause central nervous system depression.

A “Dear Healthcare Professional” letter has been sent for Ultram and Ultracet in conjunction with Ortho-McNeil-Janssen, the manufacturer, alerting doctors to the new labeling changes and contraindications. The letters did not say how many deaths had been attributed to the painkillers.

Ultram (tramadol hydrochloride) and Ultracet (tramadol hydrochloride/acetaminophen) are synthetic opioid analgesic painkillers approved for the treatment of moderate to moderately severe chronic pain. However, FDA drug safety reviewers say that the drugs have been related to deaths that have occurred in patients with a history of emotional disturbances, suicide attempts, as well as drug and alcohol addictions.

The FDA says Ultram and Ultracet overdoses can result in central nervous system depression, respiratory depression and death. They are also prone to abuse and illegal use.

The new label changes contraindicate the use of the Ultram and Ultracet for patients who are suicidal or addiction-prone. The warnings also suggest doctors use caution in prescribing the drugs to patients who are taking trauquilizers or antidepressants, as well as to patients who drink alcohol to excess and who suffer from emotional disturbance or depression.

The labels will carry extensive information on Ultram and Ultracet misuse and abuse potential, the possibility of patients seeking the drug for criminal intent, and warnings on the possibilities and effects of Ultracet and Ultram overdoses.

Tags: , , ,

There Are 14 Comments So Far • (Add Your Comments)

  1. I went to the ER a few nights ago with severe back amd neck pain and tightness. I told the nurse that I was stressed and I had a miscarriage this year and just found out the day before I went to the ER that I now have to have surgery on my uterus because of fibroids and that might affect my future in having children. Since I don’t have any children yet, that made me a little sad. At the ER I feel they didn’t listen to a word I said. They gave me a perscription for methocarbomal 500mg, voltaren 75mg and ultram 50mg. I am extremely depressed and have been since I was a child. I have been on plenty of different so called antidepresants like paxil, lorazepam, prozac and couple more I can’t remember. None worked at all. I also spent 3 days in a psyc ward in CO in 2008. They never asked any of that at the ER.

    After getting back from the ER that night, alone of course, I was extremely depressed. Me and the man I was dating were fighting, so that made things worse. I took the recomended dose then went to sleep. I woke up a few hours later feeling more sad and I swear my back hurt worse. Since one didn’t work, I then tried 2 muscle relaxers. The first day of drug taking didn’t get me anywhere so the next day I took 4 of each of the pills and laid down. I felt a little sick like I had the flu, but that’s about it. Nothin happened and I ended up at mcdonalds on the internet till I got bored. Last night I took 10 muscle relaxers and 4 atenolol cause I read online somewhere that they reacted with each other maybe. I slept for a few hours then was right back up depressed and with a tight back.

    Earlier this year I took 37 armour thyroid 60mg and about that many hours and nothing happened. I even went to work hoping I would pass out when I got there. I went to a walk in clinic after that to have my thyroid levels checked. I didn’t tell them I took 37, just that I needed it checked. The next day they said my levels were a little high and my sugar was off…..that’s it.

    Wish I would just die already….really tired of trying. I have hoshimoto’s thyroiditis…..maybe that’s why these damn drugs aren’t working!

    I was looking online for how many ultram to take since I took all the methocarbomal and it didn’t work.

  2. I WAS INJURED IN AUGUST 2007 HAVE TWO BULGING DISK IN MY LOWER BACK AND WAS PRESCIBED ULTRAM , I TAKE TWO 50MG TABLETS TWICE DAILY 200MG TOTAL A DAY I ASK FOR A LESS ADICTIVE PAIN KILLER BECAUSE OF PAST ADICTION PROBLEMS , I THINK THESE ARE JUST AS BAD OR WOURSE THAN THE OPIANT BASED PAIN KILLERS THEY MAKE ME DEPRESSED TO THEPOINT OF JUST WANTING TO SLEEP ALL DAY AND NOT WANT TO FUNCTION AT ALL IT`S LIKE MY BRAIN IS TURNED OFF IT`S HARD TO KEEP MY MIND ONE TRACK WHILE TRYING TO PREFORM MY DAILY TASK OR WORK. IT HAS ALSO LEFTME AN ED PROBLEM . I TALK TWO TWO DIFFERANT DOCTORS ABOUT HTE ED PROBLEM AND NEITHER SAY THEY HAVE EVER HEARD OF THIS MEDICATION CAUSEING THIS SIDE EFFECT , BUT I`M SAYING YES IT DOES .I RECENTLY CONTACKED MY LOCALE PHARMICY TO TRY TO GET SOME INFO ON WEANING MYSELF OFF ULTRAM AND SLOWLY REDUCING MY INTAKE I`M DOWN TWO 100MG A DAY AND WOW WHAT A DIFFERANCE HOPEFULY SOON I WILL BE RID OF THIS NIGHTMARE CALLED ULTRAM. I WOULD RATHER LIVE WITH THE CRONICK PAIN THAN LIVE THE WAY I HAVE BEEN LIVEING FOR THE PAST FOUR YEARS. I`M SLOWLY STARTING TO FEEL LIKE MY OLD SELF AGAIN , OH AND BY THE WAY MY WIFE IS A HOLE LOT HAPPIER TO AND THAT IS VERY VERY IMPORTANT TO ME BECAUSE IF MOMA`S NOT HAPPY NO ONE IS HAPPY

  3. I have been taking ultram since i was 22 for six years for back surgeries, and now at 28 if i discontinue the use of these meds, like i have tried over and over and over even when i was pregnant with my son, i go through these awful nerve “zaps” that cause my vision, hearing, and feeling in my whole body to paralyze for a split second, i go through severe with drawls compared to heroine with drawls and I go through it for weeks, i dont see them ever going away no matter how long it has been since I have taken the last dose. My life is so disrupted because i cannot do anything without having this medication, and now doctors still dont see what i have going on as a relation to the medication. i know my body someone tell me im not alone. help me, i am so miserable i do not want to live my life and have my son see that mommy isnt happy unless she takes her meds…. not my baby boy.

  4. I took ultram for 8 yrs and it caused many different problems such as tremors, shaking, nausea, vomiting, losing touch with reality, not being able to focus or function, convulsions, violent episodes(uncontrollable rage), addiction, loss of appetite and finally seizures. My life has been turned upside down not only from the ultram but from the chronic pain I go through everyday. U c I have fibromyalgia, degenerative disc disease, bulging disc @ my L4-L5 vertabrae, arthritis, and nerve damage n my right knee. I was first put on the ultram 1 3-4 times a day then eventually 2 3-4 times a day. After years of taking it I became addicted to it and was taking up to 18 a day. In the beginning I asked the doctors to put me on something non narcotic and nonaddictive which in the beginning until recently the pharmaceutical company was stating that to be true. My doctor was giving me new scripts early and I had started getting other meds off the street. I ended up having a seizure in front of my oldest child at the time and had he been at my moms where he was staying cause things were so bad at home, I would have died that day buy myself. My husband had become mentally and physically abusive towards me making peace nearly impossible. My youngest was having to be around thje vioplence all the time and it was hurting my kids so much. I finally hit rock bottom when I was taking 20 percocet a day and buying meds off the street such as oxycoton. I ended up putting myself in rehab after the meds tore my family apart and thankfully the doctor I saw put me on the medicine called suboxone. It has helped me tremendously but u have top b careful of certaoin meds u mix with it for example certain narcotic pain meds can make u very ill if u mix it with this med and certain anxiety med can kill u if u mix it with the suboxone so b sure to tell ur doctor of all the meds u take prescribed or gotten without a script off the street.

  5. I have been on Ultram for 5 months. I have a herniated L4-5. I was put on it after I told my doc that I did NOT WANT narcs or other addictive meds. Figure that one out.
    Last Thursday I had two grand mal seizures that the ER is blaming on Ultram.
    I am now suffering from extreme short term memory loss, the physical damage from the seizures themselves and I cannot work (my sister is here taking care of my job and family).
    I am terrified that I won’t recover, I am in a huge amount of pain and I am super upset that these docs are prescribing this garbage to people.
    If you are on tramadol, get help to get off it now. I have no personal or family history of seizure and it was an AWFUL experience. My life is potentially ruined at the ripe old age of 34.

  6. MY HUSBAND DIED JUNE 7 2009 FROM THIS BUT THE FDA WAS TO LATE FOR SAVING HIS LIFE. AND I CANT EVEN FIND A LAWYER TO TAKE MY CASE. SO THEY KILLED A GREAT MAN AND GOT AWAY WITH IT. I WOULD NEVER EVER SUE ANYONE BUT THIS CASE IF DIFFERENT THEY NOT ONLY TOOK HIS LIFE BUT MINE TOO. BECAUSE THEY DINT PUT A WARNING LABEL ON TO MAKE $

  7. I sympathize and empathize with all who have written on this site. We have all suffered in different ways but we have all been jerked by the current medical system. I was prescribed Tramadol around 2007 after having a hard time getting any pain medicine because I was a Katrina evacuee and the docs held it against me because I moved. I was in a tremendous amount of pain from a car accident and an underlying pain condition which was diagnosed more recently. It didn’t take long before my wife and I began to have concerns about it. It helped in the beginning but I started having more intense pain and I tried several times to get off of it. Then things got really weird. I started to have episodes where my blood pressure would rise dramatically and I would fall down and loose my balance. I also couldn’t sleep at night. I began to lose weight and could not eat as much. I started talking really fast. I did not know that I was in the hypo-manic stage of Serotonin Poisoning. Then the episodes of BP and loss of balance increased and I went to the ER several times. Then I slipped over the edge into full blown Serotonin Poisoning. My case lasted for a long time and I would have traded top have my worst pain day to not feel that way. Restless Legs from Hell: Screaming, kicking restless legs that lasted for hours at a time. Intense Fear, night sweats, diarhea, medicinal smell, oozing from every pore and oraface in my body. Yes Serotonin Syndrome can be caused by small doses of Tramadol w/o interaction with other meds. Why? Because it is an SSRI. They usually don’t tell you that because they think you don’t need to concern yourself with that. They almost killed me. I was blessed my wife figured out what was wrong with me and talked me through it- I think of people who don’t have the right people in their lives- what do they do?

  8. One dose of Ultram 50mg. put me in a very bad way. I was on clonazepam at the time and the doc assured me that was ok. Let me tell you, it was not. I had what I believe to be some sort of seizure. All I know for sure is that I lost control of my mind and body in a most unpleasant fashion. Rapid, confused speech, writhing on the floor for no apparant reason. I’ve never experienced anything like this before. It was frightining and horrific and I know it was triggered by Ultram. I then became very nauseus and couldn’t sleep for a couple days. I’m very upset with the doc who perscribed this without mentioning it’s an SSRI. I had been taking occasional Vicodin for pain following bi-laterall hernia surgery with no problems. Ultram is the worst drug I have ever taken. Don’t understand why Docs are willing to perscribe this over traditional narcotics when it is clearly a dangerous drug.

  9. Tamara, I wish there was a way for me to contact you to hear your story. I lost my husband to this drug, too. A physician prescribed this medication to him knowing he was on another CNS depressant and within 48 hours, my husband was dead. This happened AFTER the FDA issued that letter to physicians, too. So sorry for your loss. I truly, truly am.

  10. I lost my husband too due to tramadol. He was on so much other medication, and the drs kept upping his dosage. It’s been terrible since he passed.

  11. In 2007 I was prescribed Ultram for back pain. I was told by my doctors that it was “non habit forming”. I thought it was basically a glorified Tylenol. I took the drug having been told I would not get addicted. Well, I became addicted. Somehow websites selling Ultram started sending me emails, since Ultram was not a controlled substance. I found it easier to buy it online, so I did. After 4 years it was taken off the internet and I discovered I had a problem. But not after basically running my business into the ground being somewhat oblivious to what was going on around me. I have read that Ultram has a mind altering effect on people. I was not myself and didn’t proceed with caution as I normally would. In anything I did.
    I have been working with doctors to get me off of Ultram for the past year. I am getting close to being off of it.
    Terrible withdrawal symptoms and depression is now my life. Not to mention I now realize that I was not thinking with a straight mind during the 5 years I was on it.
    I am now seeking a law firm to represent me, as I was told the medication was non addictive and only a pain killer. Not a mind altering drug.
    I feel that once the drug had control of me, I had no real control over my brain and decision making.

  12. Tamara , Jaxsterly and Kathy… I too wish I could contact you to hear your stories. I lost my husband last year to suicide after being placed on tramadol. This is a horrible medicine and should be taken off the market.

  13. I’ve been addicted to ultras since 95.I take 30 pills in 1 dose.In 2011 over the Christmas holiday they made a mistakes and had given me 710 pills.They were gone in 5 says.I am sick all the time now.I am making an attempt to stop.please contact me of you want this medicine taken off themselves.I was addicted to bikes and the
    Withdraw is not the same but worse.I hav wasted a big part of my life on this.15 years.I can’t hold on to a job,I lay in bed Cus IM soon add.Img have a great pysce doc and he is helping me.But am afraid I won’t Walt up

  14. Most attorneys advertising to help tramadol ultram users are simply statistic takers for big pharmacy. They will not sue the company but will pass your information on to the manufacturer. This is how all mega corporations operate now under the master mason, drug cartel goverment we now have.

Post Your Comments

  • Have Your Comments Reviewed by a Lawyer

    Provide additional contact information if you want an attorney to review your comments and contact you about a potential case. This information will not be published and will be confidential.
  • NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

  • This field is for validation purposes and should be left unchanged.