FDA: Warning for Tramadol and similar drugs

[brs0660]

Tramadol (Ultram and Ultracet) Linked to Risk for Serotonin Syndrome
On September 9, the FDA approved safety labeling revisions for tramadol HCl (marketed alone and with acetaminophen as Ultram and Ultracet tablets by Ortho McNeil Pharmaceuticals) to warn of the potential risk for potentially life-threatening serotonin syndrome.
Serotonin syndrome may occur with use of tramadol alone but particularly in combination with use of serotonergic drugs such as selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), and triptans; drugs that inhibit serotonin metabolism, including MAOIs; and drugs that impair the metabolism of tramadol, such as cytochrome P 450 isoenzyme 2D6 (CYP 2D6) and CYP 3A4 inhibitors. Adverse events may occur at the recommended tramadol dose, the FDA said.
Symptoms of serotonin syndrome may include mental status changes (eg, agitation, hallucinations, and coma), autonomic instability (eg, tachycardia, labile blood pressure, and hyperthermia), neuromuscular aberrations (eg, hyperreflexia and incoordination), and/or gastrointestinal tract symptoms (eg, nausea, vomiting, and diarrhea).
Tramadol is indicated for the management of moderate to moderately severe pain in adults. Administered as a combination tablet with acetaminophen, tramadol is indicated for the short-term (≤ 5 days) management of acute pain.

Information taken from Medscape CME website

 

[Pat29627]

I always check drugs and supplements with something like
https://www.medscape.com/druginfo/druginterchecker or
https://www.drugs.com/drug_interactions.php

 

[Josephine]

I can't find it right now, but the incidence of those reactions was remarkably low. Tramadol is considered a popular and very safe medication - actually safer than morphine.

 

[Texas]

Is tramadol like morphine . sorry I just dont know never had it but alot of people seem to take it .....seems to work

 

[Josephine]

Tramadol (or Ultram) is a synthetic morphine.

 

[kimberlyann]

Well, I went out reading about Tramadol online. As I stated before, and as others have said, it really interferes with my sleep, and has caused terrible nightmares for me. I have woken up more tired than when I went to bed after taking this. But , I found a very interesting statement while reading on Wikipedia.

Through a confluence of pharmacodynamics, large doses of instant release tramadol is likely to cause tachycardia and extreme panic, as the acute SNRI effects predominate. The more desirable opioid effects (which are due mainly to the M1 metabolite, after 1st pass hepatic), are more pronounced with the ER, as tramadol is not dumped into the system all at once. Thus, the acute (undesirable) SNRI effects are largely avoided, while the longer term, more desirable opioid effects, are enhanced. Another way to get a similar overall effect, would be to take a small dose of tramadol every half hour, being very careful to watch total intake (tramadol can be a very dangerous drug).

It makes perfect sense to me, after stating that the 50mg immediate release really bothered me, but the 200mg, longer release did not.
Very interesting.

It also stated that Tramadol is most similar in chemical structure to Venlafexine, or Effexor, which is an anti-depressant.

So, in my humble opinion, it makes perfect sense that like with most anti-depressants, it could be the perfect choice for pain relief for some, while it can definitely cause major CNS disturbances in others.

very cool!

 

[beth1954]

Kimberly Ann--that scares me half to death. By the way, I love that drug.com site. Very helpful. I put in all the different drugs that I'm on and each one had a warning on it. I'm afraid to take any of it at this point!

 

[Jamie]

Beth, please...please don't let yourself get too worked up over warnings you are reading about on the internet regarding drugs that are currently on the market and approved by the FDA. All side effects must be listed by law but in reality they occur in such small numbers that the risk is very slight. Information read on the internet can be VERY helpful at times, but it can also be dangerous to your mental state if you are not able to read it in the proper context.

Drugs in the USA are tested extensively and approved. You have doctors and pharmacists that study the trials and keep up to date on how the drugs work. You need to put your trust in them when they prescribe a certain medication for you. Ask questions, for sure....but in the end, you should trust that they are strong medical professionals with your best interest at heart unless something happens in your relationship with them to indicate otherwise.

And as for getting a warning on every drug you type into that web site, it's true. Frankly, you'd probably get a warning if you typed in tap water! Everything has a benefit and a risk. Fortunately most of the time the risk is much, much less than the benefit.

One thing that IS important on these web sites and with the warnings, is to heed the drug interactions and warnings about activity to avoid while taking the drug. It is good as a patient to be aware of potential interactions with certain drugs and between drugs and some foods. That is real. And when a drug warns of drowsiness, it means you shouldn't drive or drink alcohol when taking it. These are the type of warnings you should be paying attention to.

So if you find yourself being scared....stay off those sites and discuss any questions you have here on the forum or with your doctor or pharmacist. I don't want you to worry needlessly.

 

[Lakesideview]

Well I just heard that Sweden has placed Tramadol on the "narcotic" list. I personally took it for 4 years with my Doctors consent and have recently weaned myself off of it. For 3 years now I have had unexplained nerve pain in both arms and hands. After numerous tests and even one shoulder surgery (doc came right out...nothing wrong in there) it still could not be explained. Well folks, after being off Trams now for only 2 weeks the nasty nerve pain is GONE! So is the restless leg that I suffered from almost nightly. My advise: Use it only for short term or occasional use for pain.

 

[Josephine]

I'll say it again - side effects such as you have posted there are pretty rare - note that those drug sites hardly ever cite any incidence values. All narcotics can be dangerous and Tramadol, being a synthetic morphine, is a narcotic. These things have to viewed in perspective.

 

[BigRed]

My OS gave me Tramadol when I was released from the rehab hospital. I found it to be completely ineffective in relieving pain for me and got my primary physician to prescribe oxycodone which is what I had been using in the hospital. That did the trick for when I needed it. i no longer take anything but Celebrex.

I agree with others, though, that the warnings that are given for side effects are telling you the worst that can happen but they are very rare. Work with your doctor letting him/her know of your concerns and make an informed decision as to what meds to take.

 

[Josephine]

No drug works for everybody. But most work for most people.

What's that saying?

You can please some of the people some of the time, all of the people some of the time, some of the people all of the time but you can never please all of the people all of the time?

 

[TBONE]

On the other hand, Tramadol worked great for me. Not as overpowering as Vicodin or Percacet, with fewer side-effects, in my opinion.

 

[Janey]

Hi Debbie. I have read yr posts re use of Tramadol as have bn on it for 2 years, taking 2x50mg 4x per day. Am 3 wks out of partial at present and wd like to wean myself off in a few wks, not ready yet. Did miss a days pills when I ran out before op, and didnt feel great, sweats, heart racing and quite agitated. Will take note of yr gradual approach and will maybe ask for alternative when time comes. Hope all good with you now.

Janey

 

[Josephine]

You will need to make a plan for weaning yourself off them and stick to it like glue! It will probably take about 4-6 months.

 

[Lakesideview]

Hi Janey. Just as Josephine says you need a good plan. I could not just cold turkey that one and I think it would be dangerous to do so. I found some suggestions from an opium withdrawel website that worked well for me. They suggested 100mg of vit. B daily, Sam-e(2 to 4 pills a day) and 2 pills of 5HTP a day. The Sam-e is for mood swings and the 5Htp is a seratonin regulator which is the area of your brain which the Tramadol affects. I tapered very slowly, even cutting my pills in half towards the end. I stayed at the dose for a week and then cut back again. I still had a few nasty nights of restless legs and wakefulness but it was not to bad. The above products are all supplements and can be easily purchased at drugstores or online. Goggle for info on all of them. I have been off the meds now for over a month and feel better. Tramadol is a wonderful pain med but I was on it far to long. Good Luck!:thmb:

 

[HopAlong]

I was given tramadol before my THR, but refused to take it when i found out it was made by Pfizer, and that it works in the brain the same manor that Chantix (another Pfizer drug) does. Chantix demyelinated my nerves, and i was in severe nerve pain for 2 years. It also caused muscle and bone pain too.
When talking to Dr. Betty Martini, who was an FDA doctor for 17 years, now retired, she told me that she personally wouldn't trust any drug that Pfizer made. You can look her up online, she is now an advocate against the FDA.

Hop

 

[Josephine]

What's the issue with Pfizer then?

 

[HopAlong]

I don't know how much of U.S. issues you follow, but last January, as soon as Obama took office, he received a letter from 21 FDA scientists asking him to look into the corruption. Weeks later the FDA laid them all off, and I don't know if they ever got their jobs back. It became a big "whistle blowers" case after.

Betty Martini is was an FDA doctor for 17 years, and now is a whistleblower as well.
Here is her contact info.....she usually sends very thorough replies to questions. Her main concern now is getting aspartame off the market, because it has been proven to cause M.S., ALS, and other deadly diseases, but she is very knowledgeable on Pfizer drugs as well.

Dr. Betty Martini, D.Hum.
Founder, Mission Possible World Health International
9270 River Club Parkway
Duluth, Georgia 30097
770-242-2599
E-Mail: [email protected]
broken link removed: https://www.wpwhi.com
https://www.whno.net
broken link removed: https://www.dorway.com

Aspartame Toxicity Center: https://www.holisticmed.com/aspartame

 

[Janey]

Hi Debbie thanks for details on how you weaned yourself off Tramadol. I hope to be able to show my GP this thread and come up with a plan. I will let you know what I get up to!! I have to say, whatever the pros and cons it has certainly helped me thro the past couple years of decreasing mobility and increasing pain and provided I can come off them w/out too many side effects I will be satisfied.