FDA warning on Tramadol.

Discussion in 'Fibromyalgia Main Forum' started by gapsych, Aug 21, 2010.

  1. gapsych

    gapsych New Member

    I found the following information on http://guideline.gov/content.aspx?f=rss&id=15525

    My doctor was already aware of this since Tramadol works with seretonin and if a patient does not or is unable to disclose all the medications taken, may be at risk for seretonin sickness as well as suicidal ideation, but the FDA has now made it official.

    I've been taking Tramadol for five years, not having any reactions, so will continue to take it but knowledge is power!!!!

    Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change
    Audience: Pain management healthcare professionals

    [Posted 05/25/2010] Ortho-McNeil-Janssen and FDA notified healthcare professionals of changes to the Warnings section of the prescribing information for tramadol, a centrally acting synthetic opioid analgesic indicated for the management of moderate to moderately severe chronic pain. The strengthened Warnings information emphasizes the risk of suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs and also warns of the risk of overdosage. Tramadol-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts, as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Tramadol may be expected to have additive effects when used in conjunction with alcohol, other opioids or illicit drugs that cause central nervous system depression. Serious potential consequences of overdosage with tramadol are central nervous system depression, respiratory depression and death. Tramadol has mu-opioid agonist activity, can be abused and may be subject to criminal diversion.

    [April 2010 - Dear Healthcare Professional Letter: Ultram - Ortho-McNeil-Janssen]
    [April 2010 - Dear Healthcare Professional Letter: Ultracet - Ortho-McNeil-Janssen]
  2. Sacajawea2

    Sacajawea2 Member

    Yes, that happened to me...

    I was on ultram for a few years (started on it in 1999) and then ultracet (worked better for me). In 2003 I started taking Zoloft (25 mg). I continued to take the ultracet, anywhere from 1-6 tablets a day, usually 2 or 4. I had no problems. Then one doctor wanted to up the Zoloft (around 2005), so he did. I actually could hear "frying" sounds in my brain!!! I found it difficult to breathe or move. So I stopped the Zoloft increase and stayed at the 25 mg despite the doctor telling me not to worry about it.

    Then I got a script for Imitrex (for migraines). I called the pharmacy after reading the warnings about too much seratonin. Well, I got really sick. I didn't make the connection because I didn't take Imitrex too often and made sure I didn't mix it with the other meds when I did need it. I was on other meds as well.

    So fast forward another year or so and a doctor insisted that 25 mgs of Zoloft was not enough and upped it again to 50 and then 75. By then I was not taking Imitrex and taking less Ultracet (had stronger meds for break-thru pain). However, the increase in Zoloft gave me the frying sensations in my brain again, so loud it sounded like I could hear it. I also started having muscle twitches and difficulty breathing and I felt like I forgot how to speak. I thought I was having a stroke and just stayed in my bed, unable to help myself or call for help for more than a day. I found a new doctor after that. He took me off all three of the meds.

    So for many years Ultracet worked fine for me. After that happened, I couldn't take it without extreme side effects. So last year my doctor gave me a small script for tramadol. ONE 50 mg pill and I felt like I couldn't talk in a normal tone, I didn't make sense and I felt extra dizzy. I felt "high"...so I set them aside and didn't touch them again until about two months ago. I was out of my regular meds (I take vicodin and Mobic for pain right now). Again, crazy symptoms. So my new doctor (since December) said the reaction I had some years ago will probably never go away. So no more meds in the seritonin family for me.

    What angered me was that I DID see the warnings and called the pharmacy and my doctor and was dismissed, that it wasn't enough. Later when I went through a battery of tests and was diagnosed with a rare genetic movement disorder on top of this other stuff, my neurologist said he believes that I probably had a seizure, possibly from the drug, definitely not related to the genetic disease.

    At one point I had fainted at Target, ambulance called and I refused treatment (oh I forgot to add, the difficulty breathing was labled as asthma) once I came to. Next day I nearly passed out at a friends, ambulance called and this time I was taken to emergency. I was also on Klonopin at the time. Doctors said my situation was from dehydration and heat, never said a word about the other meds. I wasn't dehydrated, and it's possible I did have a seizure but we'll never know.

    The sad thing is, the Zoloft and Ultracet were both working well for me...now I'm not on any antidepressant. I am afraid to try anything else, yet I struggle with the blues a lot lately. It's been a rough few years. Vicodin helps, thankfully but I can only handle half a pill at a time.

    Right now I'm on Vicodin, Mobic, Lidoderm patches (they do help somewhat and you can use up to three at a time but I'm not comfortable with them on me). I also have a script for Volterin (sp?) gel, an NSAID. I usually take mobic for three days on, three days off or for no more than two weeks at a time. I also use some alternative gel that works well on my muscles but not on the lower back or neck.

    Sorry to go off topic a bit, but yes, check your labels and call a second pharmacy or get a second opinion if needed.


    [This Message was Edited on 08/21/2010]
  3. gapsych

    gapsych New Member

    SJ, sorry you went through this. When I started on Trammed and let my psychiatrist know, the first thing he did was to look at all my meds., which he always does, to make sure I was on the right amount and this was five years ago.

    Not sure if what you had was seratonin sickness or not as I am not a doctor. I am somewhat confused about the dosage you said you take of Zoloft. I take 100 mgs. during the summer and 150 during the winter.

    Jam, I can take up to two 50 mg. three times a day. It has been the only thing effective for my pain. When I am in a bad flare I have had to add Tylenol as long as I do not go over the amount of each and not take them at the same time. Narcotics such as Darvacet do not help me. However since I am now on CPAP and sleep is tied in with pain, I only average about 100 mgs. a day.


    ETA I am surprised that the pharmacist did not know about this effect since they know how medications work. Bummer. Is Ultraset the timed released form of Ultram?

    [This Message was Edited on 08/21/2010]

    ETAA Ultraset has Tylenol in it. I was not aware of its existence.[This Message was Edited on 08/21/2010]
  4. rosemarie

    rosemarie Member

    My Mom was given this meds she had severe recation as a result of taking Ultram. She acted so strange that she worried her doctor and family. At the time of this she was 80-81 yrs of age. It caused her to hallucinate severaly. Once she was taken off this med she returned to normal.

    I took Ultram once in my life and It caused me to have the worst panic attack, I will never take it again. This also happened to my oldest daughter when seh was in her teens and took it for tooth pain. No one ever belived me that thhis med could affect me in a strange way.

  5. keke466

    keke466 New Member

    I've had a prescription for 50mg for a few yrs now and I haven't had any reactions. I also take 50mg of zoloft and lately I've been 100mg of it. Maybe I haven't had any reactions to the ultram because I don't take it on a regular basis. I only take it when I can't take the pain anymore. I don't like to take pain meds or anything unless I absolutely have to. I am in pain but I try to just deal with it. My feet and legs hurt more than anything.
  6. ellikers

    ellikers New Member

    I'm glad it's helped some people because my reaction was also crappy.

    A NP put me on this med in June after I had a bad pain flare and requested something to help because vicodin was only taking the edge off.

    I had fitful insomnia on it (doesn't help my body at all clearly) where I had half awake/half asleep dreams/hallucinations, and was teary and felt like my head was floaty and it was challenging to think and maintain normal speech (I thought I wasn't making any sense to people but they said I was). Ugh! And it really didn't help pain ANY better.

    I took myself off of it after the only advice I got from that NP (not going back to that one again) was "Just don't take it at night or close to bed."

    Uh, really? If I can't take a pain med within6 hours of THINKING about going to bed, that doesn't sound like a helpful pain med. IN the SLIGHTEST.
  7. gapsych

    gapsych New Member

    Did you gradually get off the Vicodan? Could you have been experiencing withdrawal?

  8. ellikers

    ellikers New Member

    Nope, it wasn't vicodin withdrawal as I only take it as needed and not every day.

    If I have a really bad flare of pain (a bunch of trigger points going off at the same time) then I might be on it for a couple of days but when the flare eases up I don't take it anymore. I was using the tramadol as needed too ... but clearly it wasn't working well at all.
    [This Message was Edited on 08/27/2010]
  9. positiveone

    positiveone New Member

    Between taking tamadol in the day and taking 1.5 mg klonipin at night...i can lead a fairly normal life.

    Without the tramadol I have too much pain. I was taking one 50mg in the morning and one 50 mg at noon. I am now taking three a day since I fell at Fred Meyer. My back is in horrible pain but without it I cannot function.

    This helps better than the oxycodone she prescribed after my fall, which does not touch the pain so I just take extra tramadol. The oxy was horrible on my digestion and that made it all the worse.

    I have been taking Tramadol about 3 years and it has been a savior for me. I also take 5 mg lexapro. I went off it for a month too see if I needed it but I felt so much anxiety. I had no idea it helped so much with that.

    I was taking 10 mg but have been on the 5 mg about 2 months now and it helps the anxiety and that is where I have my problem because it is enough.

    I wish you luck.