FDA Tramadol and Black Box warning??

cabin111
on 3/23/16 9:35 pm

So yesterday the FDA came out with a black box warning for many opioids such as Hydrocodone and Vicodin.  Does this apply to Tramadol also??  DO YOU KNOW?  Can you show a link to which drugs are on the list??  Please no...WELL I THINK??  Please show me the list that will be black boxed.  We who have had RNY are very limited in what we can use for painkillers. 

Kakesie
on 3/24/16 5:48 am
RNY on 02/19/16

What does "black box warning" mean?  I had RNY but I also have liver disease so I can't even take Tylenol.  So Tramadol is my ONLY option for pain.

~ Karen

CerealKiller Kat71
on 3/24/16 6:10 am
RNY on 12/31/13

A black box warning is the strictest warning put in the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA) when there is reasonable evidence of an association of a serious hazard with the drug.

The FDA is requiring a new black boxed warning about the serious risks of misuse, abuse, addiction, overdose and death.  The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

 

"What you eat in private, you wear in public." --- Kat

Kakesie
on 3/24/16 6:19 am
RNY on 02/19/16

Thank you, Kathryn!  :)

Heavens2Betsy
on 3/24/16 6:16 am
RNY on 02/29/16

Your pharmacist would know.  I'd say give 'em a call.

Age: 55.  5' 8" SW 345 lbs.  RNY on 2/29/16 at UVA w/ Dr. Hallowell.     
Month 1 - 3/29/16: 319 (25 lbs. lost) | Month 2 - 4/27/16: 314 (5 lbs. lost) | 
Month 3 - 5/29/16: 303 (12 lbs. lost) | Month 4 - 6/28/16:  293 (10 lbs. lost)
Month 5 - 7/28/16: 289 (4 lbs lost) | Month 6 - 8/28/16: 282 (7 lbs. lost) |
Month 7 - 9/27/16: 278 (4 lbs lost)

CerealKiller Kat71
on 3/24/16 6:18 am
RNY on 12/31/13

You can search black box drugs by name here:  Black Boxed RX list -- you won't be able read all the information without becoming a "member" but you can see if a drug is boxed or not.  Tramadol is not an opiate, but you can find the boxed warnings here:  FDA warnings for Ultram (tramadol)

Tramadol does not appear to be black boxed.  

Here's a link to the reasoning behind black boxing opioids:

FDA announces enhanced warnings

"What you eat in private, you wear in public." --- Kat

Kakesie
on 3/24/16 6:22 am
RNY on 02/19/16

Thank you VERY much, Kathryn!!!  :)

Grim_Traveller
on 3/24/16 2:12 pm
RNY on 08/21/12

I was always told it was not an opiate as well, and pointed that out to someone on another thread just a few days ago. Hala posted a link to another site that said it was an opiod. So now I'm not sure what to think.

6'3" tall, male.

Highest weight was 475. RNY on 08/21/12. Current weight: 198.

M1 -24; M2 -21; M3 -19; M4 -21; M5 -13; M6 -21; M7 -10; M8 -16; M9 -10; M10 -8; M11 -6; M12 -5.

CerealKiller Kat71
on 3/24/16 2:30 pm
RNY on 12/31/13

I stand corrected.  Geez, it is a synthetic opiate.  Odd!  I am rarely, if ever, wrong about anything!  LOL

 

"What you eat in private, you wear in public." --- Kat

Grim_Traveller
on 3/24/16 2:47 pm
RNY on 08/21/12

I remember distinctly when it was first prescribed for me, and the doctor said it was not addictive because it was synthetic, and not an opiate.

It strikes me as pedantic, but perhaps there is a distinct scientific difference between an opiate -- something derived from opium -- and an opiod, which is what tramadol is?

6'3" tall, male.

Highest weight was 475. RNY on 08/21/12. Current weight: 198.

M1 -24; M2 -21; M3 -19; M4 -21; M5 -13; M6 -21; M7 -10; M8 -16; M9 -10; M10 -8; M11 -6; M12 -5.

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