Dear Brian,

 

Thank you for writing to Sarah Peddicord in the FDA's Office of Media Affairs. Your comments were forwarded to the Division of Drug Information in the FDA's Center for Drug Evaluation and Research for a response.

 

Your original email in March expressed concern over a possible boxed warning issued for tramadol use in gastric bypass surgery patients. There do not appear to be any new boxed warnings added to tramadol products since September of 2015.

 

However, a new boxed warning is likely be added soon because tramadol is an opioid and all opioids products are required to add a new boxed warning about the serious risks of misuse, abuse, addiction, overdose, and death. This warning is not limited to or targeted at gastric bypass patients.

 

The most complete source of information on tramadol products may be found in the labeling for Ultram (tramadol), available online in our drug information database, Drugs@FDA. There do not appear to be any boxed warnings for tramadol.

 

Other FDA actions taken for opioid pain medications in late March of 2016 included class-wide safety labeling changes for immediate-release opioid pain medications. Tramadol is included in the list of opioid medications and is therefore included in these labeling changes.

 

The required labeling changes were issued in a Drug Safety Communication on March 22, 2016. The labeling changes include a new statement to be added in the Warnings and Precautions section about serotonin syndrome and adrenal insufficiency, and the addition of decreased sex hormone levels to the Adverse Reactions section of all opioid labels.

 

None of the actions taken in March of this year appear to be specifically related to gastric bypass patients. If you are having difficulty obtaining your medication, please speak with your pharmacist. If you have concerns about taking tramadol, please speak with your prescriber or other health care professional.

 

Best regards,

 

LE | Pharmacist

Drug Information Specialist

Division of Drug Information | Center for Drug Evaluation and Research

Food and Drug Administration

 

For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter @FDA_Drug_Info

This communication is consistent with 21 CFR 10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.

That is interesting, but honestly I don't understand why you are so concerned about a warning label.  I mean, it's just a label and won't actually affect you, really.  Is it that your doctor doesn't realize that this drug is an opiod and that it could become addicting and you don't want him to find out?  

What is your worry all about?  If it's just a warning label letting people know that it could be addicting, isn't that a good thing? Regardless of if you are a WLS patient or not, knowing something has addictive properties IS a good thing.  ESPECIALLY being a WLS patient it's a good thing, since transfer addiction is a very serious problem.

Yes, I know it is and can be addicting.  The problem is it requires much more documentation with the PCP and visits.  And it must be with a physician not a NP or PA.  Also PCP's (doctors) are harder to get an appointments now a days.  NO, I am not addicted to Tramadol.  But when my bad back flairs up I really can use it.  It can be the best choice for RNY patients with certain issues.

There is just so many more hoops to jump through to get black box meds.  Many who use this drug will see this when their doctor goes on vacation or retires.  Other doctors will have to go back 10-15 years in our notes to see what the problem was/is before they can prescribe.

Can you see a doctor saying "I need a new MRI for your back...To cover my backside"!!  A bit costly and time consuming.  So while you wait and if you don't have any tramadol your choices are; go with Ibuprofen (God forbid) or try and find tramadol or hydrocodone on the black market.  I don't want to or need to go the oxycontin route...Never would go there unless I'm dying and have about 1 month to live.  So those are the issues.  Many of you will see what I mean when you have major pain and must go this route.  It may even change some peoples choice to go with the sleeve rather than RNY...Depending on if they have current pain issues pre op.  Brian

But do you believe that the black box warning is unwarranted overall?  Do you disagree with the fact that this is an drug that can be dangerous for many?  Sometimes all we can see is our interest.

Example:  I am not an alcoholic, so I don't think that there should be warning labels or special restrictions on alcohol because it will inconvenience me.  To hell with others who may not know the dangers of using alcohol or the problems it can cause someone who abuses it.  

Opioid derivatives and other pain medication should only be prescribed by one prescriber for most patients, otherwise there is a danger of overprescription, so the argument of another provider going back '10-15 years' is not germane here.

Too, if I were taking a medication for '10-15' years for say, back pain, I would hope for some diagnostic imaging.

I don't understand why you are so upset over this. 

 

So my doctor (PCP) is about my age 60...And is almost ready to retire.  He has dropped down to 4 days a week.  He said in a few months or weeks he'll drop down to 3 days, then 2 days...Then retire.  I hope to stay with his office (Family Practitioner)...But it has become 2 1/2 doctors and 4 NP/PAs.  It could take months to get in to see a real doctor...There is becoming a national shortage of PCPs.  In the public sector (in California) it is even worse...Medicare type programs.  You will only be able to see a NP/PA or a resident physician...Who needs to get all OKs from their physician supervisor.  So yes, I will change doctors...And they (if they can find my charts) will probably require an MRI and Xray to tell me I have arthritis in my back with a pinched nerve...Which is in my chart from many years back.  Your insurance premium will help pay for it.  They may require it once a year!!  Nothing has or will change with my body in that area.

Also when you go to most hospitals you will be seen by a hospitalist.  Because of cutbacks, most hospitalist are NP/PA who work under an ER specialist doctor.  See the post below...This is what is coming down the line.  Good luck when you get into a nursing home/physical rehab facility.  This will matter to RNYer years down the road.  Brian 

Thank you for explaining your conncern. I do think you are borrowing trouble. For example, if you anticipate needing office visits at regular intervals, schedule them as far in advance as allowed, say every three months for a year.

You say you won't have any changes to your condition, but that is unlikely. Your condition will likely change. However, at this point, there is nothing to say you would have to have a yearly MRI; that is supposition. 

I know from my professional experience that insurances require medical necessity for diagnostics; 'because doctor said' does not fly. 

Also, not all states have hospitalists who are NPs or PAs. In my state, many of them are MDs. It makes sense to me to see a hospitalist while hospitalized, since ER doctors can be quite busy. 

Lastly, I am not concerned overly that my premium may pay for your care. That is how insurance functions, and I did vote for the current president and like the Affordable Care Act.

"Other doctors will have to go back 10-15 years in our notes to see what the problem was/is before they can prescribe."

-You think Docs that have 10-15 minutes with a patient are going to go through 10-15 years worth of notes.

I have already had an emergency room doctor argue with me when I asked for Tramadol.   He told me NSAIDS would be sufficient and that I was just being stubborn by not taking them.  He did finally write the prescription but he was irritated that I insisted on it.

I am sure that situation will be even more common once the blackbox warning goes on

Just ask him for address that the malpractice suit can be sent to when your stomach goes.

Doctors bury their mistakes.

 

Just saying