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Unread 05-26-2013, 12:21 AM   #1
ClassicStyle
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Thumbs down Suboxone generic pills do not work i am so sick

Hello everyone, I have been a silent supporter of this forum because Suboxone saved my life. It is truly a miracle cure and has helped me finally to live a happy life, be a better mother to my children, a responsible tax payer and a very compliant patient. Well this month my insurance company switched me from the Name brand Orange Pill Suboxone to the generic white Buprenorphen/Naloxone pill. At first I couldn't figure out what was happening, my legs started hurting horribly, I was waking up in the morning and vomiting , I was taking my medicine, like I was supposed to , then I'm getting the sweats, and having massive bouts with diarrhea - then it hit me - 3 days into this and I'm in full blown WITHFRAWL from the SUBOXONE . THE GENERIC FORM OF SUBOXONE DOES NOT WORK. I can wait to reach my Dr. On Tuesday- It is memorial weekend so I'm suffering terribly - but my doctor will switch me to the NON GENERIC FILM as soon as Zi reach him on Monday. How can they approve generics that don't match the name brand drugs?? I hope this doesn't get too bad. My advice to anyone switching from name brand suboxone to the generic pill form would be to ask your doctor for the film so you can avoid this pain. Talk to your doctor before your insurance company switches you. Or you get switched because of the new generic. I'm so very very sick. SHAME ON THE FDA. Shame! Good Luck everyone.
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Unread 05-26-2013, 01:13 AM   #2
OutOfOurBoxes
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I had the same issue, I can't tell you how much I agree with you on this.I asked myself the danger question, how did this get approved? There is no way that any of the people who were used in the study for this medication were already on suboxone films/tablets. If they were then there it's no way that most or all of them did not experience withdrawl when switching to the generic... I don't understand how the FDA approved this med :-\ it doesn't make sense.
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Unread 05-26-2013, 01:25 AM   #3
ClassicStyle
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Thank you so much for your confirmation of my situation. I am so shocked that I am experiencing this. I have never had to go through anything like this and I absolutely blame the FDA. I would just ask as we seem to be beginning to publicly discuss this situation, everyone who goes through this MUST report their symptoms to the FDA. Someone got away with Murder here. Imagine all the people who are sick? Everyone's being forced into the generic by insurance companies. I would not wish this pain on anyone. How did you deal with this? Did your doctor give you the films? I hope and pray that my doc will give me the films - because my insurance company is already fighting paying for name brands. Are the brand name pills off the market completely? Am I correct in my approach to my doc? The film will fix this right??
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Unread 05-26-2013, 08:32 AM   #4
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Hi ClassicStyle, welcome. Hi Dre.

Sorry you're both having problems with the generic Suboxone tablets. Also, thanks for posting - we haven't heard much about the generic Suboxone - except that they're not cheaper than the film.

ClassicStyle, have you tried taking more of the generic so you can at least feel ok until you can get in touch with your doctor? Reckitt Benckiser did discontinue the brand name Suboxone tablets in March, so if any are available, it's what hasn't sold yet. Have you looked on your insurance company website to see if there's any way you can appeal them not covering the brand name film?

Hopefully your doctor won't have a problem switching you back - do you have the $50 coupon for the film? It expires June 30.
http://suboxone.com/patients/about_s....aspx?cid=subx

As far as the FDA approving any generics, the generics do not have to do the clinical trials like the brand names did. Here's an interesting page on the FDA site about generics:
http://www.fda.gov/Drugs/ResourcesFo.../ucm167991.htm

How generics are approved:
http://www.fda.gov/Drugs/ResourcesFo.../ucm100100.htm
"How are generic drugs approved?

Drug companies must submit an abbreviated new drug application (ANDA) for approval to market a generic product. The Drug Price Competition and Patent Term Restoration Act of 1984, more commonly known as the Hatch-Waxman Act, made ANDAs possible by creating a compromise in the drug industry. Generic drug companies gained greater access to the market for prescription drugs, and innovator companies gained restoration of patent life of their products lost during FDA's approval process.

New drugs, like other new products, are developed under patent protection. The patent protects the investment in the drug's development by giving the company the sole right to sell the drug while the patent is in effect. When patents or other periods of exclusivity expire, manufacturers can apply to the FDA to sell generic versions.

The ANDA process does not require the drug sponsor to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. This applies to drugs first marketed after 1962."

Here's a way to file a complaint about the generics:
https://www.accessdata.fda.gov/scrip...tch-online.htm

One thing about the generics is that they do not have to have the same inactive ingredients. Here's the ingredients in each of the different company formulation:

Ingredients in Reckitt Benckiser (brand name) Suboxone:
SUBOXONE is an uncoated hexagonal orange tablet intended for sublingual administration. It is available in two dosage strengths, 2mg buprenorphine with 0.5mg naloxone, and 8mg buprenorphine with 2mg naloxone free bases. Each tablet also contains lactose, mannitol, cornstarch, povidone K30, citric acid, sodium citrate, FD&C Yellow No.6 color, magnesium stearate, and the tablets also contain Acesulfame K sweetener and a lemon / lime flavor.

Actavis:
11 DESCRIPTION
Buprenorphine HCl and naloxone HCl sublingual tablets are uncoated white to off-white, round tablets, debossed with on one side and a numeric imprint identifying the product and strength on the other side. It contains buprenorphine HCl, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid receptor antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual administration and is available in two dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone. Each sublingual tablet also contains citric acid anhydrous, crospovidone, lactose monohydrate, magnesium stearate, mannitol, N&A lemon FL, pregelatinized starch (maize), povidone, sodium citrate, and sucralose micronized.


Amneal:
Buprenorphine HCl and naloxone HCl sublingual tablet, 2 mg/0.5 mg is an orange, round, biconvex tablet debossed “A” on one side and “14” on the other side. Buprenorphine HCl and naloxone HCl sublingual tablet, 8 mg/2 mg is an orange, round, biconvex tablet debossed “AN 415” on one side and plain on the other side. They contain buprenorphine HCl, a mu-opioid receptor partial agonist and a kappa-opioid receptor antagonist, and naloxone HCl dihydrate, an opioid receptor antagonist, at a ratio of 4:1 (ratio of free bases). It is intended for sublingual administration and is available in two dosage strengths, 2 mg buprenorphine with 0.5 mg naloxone and 8 mg buprenorphine with 2 mg naloxone. Each sublingual tablet also contains the following inactive ingredients: acesulfame potassium, anhydrous citric acid, artificial lemon flavor, FD&C Yellow No. 6 Aluminum Lake, lactose monohydrate, magnesium stearate, mannitol, povidone, sodium citrate and starch (corn starch).

What's interesting is that the Actavis generic has crospovidone and the RB and Amneal formulations do not. Crospovidone is a filler:
http://www.drugs.com/inactive/crospovidone-31.html

The generic Subutex that gets the most complaints of not working the same as the brand is the Roxane brand. Interestingly, that has the crospovidone and the other generics don't. I wonder if that one filler makes a difference for absorption for some people?

Subutex and generic -tex ingredients:
http://www.addictionsurvivors.org/vb...ad.php?t=26807

I hope that's somewhat helpful - if you got through all that. lol

Nancy
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Unread 05-26-2013, 10:56 AM   #5
OutOfOurBoxes
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Hi Nancy, and thank you so much for letting us know that. Now that really makes sense. I haven't tried the amneal generic, only the actavis and as you know I was suffering with head aches and just a horrible feeling over all, but I eventually realized that it must have been some type of withdrawal. And I'm so glad you pointed out that the ingredient in the activis generic is the same ingredient thats in the generic subutex that is giving people problems. I wish I would have asked to try the amneal med after I seen my doctor, but I just had him switch me back to the suboxone tablets. The price of the tablets kill me and I can hardly afford them, but im nervous about trying the film again because of the mouth issues I dealt with a couple years ago, but I know im not gonna have much of a choice for too much longer. I just keep hoping that the new buccal films/New tablets from orexo and bema will come out before I have to switch back. If I had to go back to the films before then, I would, but I guess amneal is always an option especially since it doesn't have that one ingredient and might absorb differently. Im just always nervous to try any of them now, especially when I know I have one that already works and doesn't have too many side effects (if any), but the cost is what will force me to.
Thank you so much for letting us know about that Nancy, im just glad that I'll have that info in the back of my mind just in case.

TO .''CLASSIC''- I would think about what Nancy said.. Also, if the film's are not a possibility or if at some point you have no choice, but to take a generic, maybe we'll have better luck with the amneal generic?

Now that Nancy pointed that out about the generics and how they work and get approved that is something to for everyone to think about before taking a generic in the future (without doing some research first anyway)... thanks again Nancy... Dre
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Unread 05-26-2013, 12:47 PM   #6
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Thank you Dre and thank you Nancy. I just don't know what to do. I feel so very bad - nausea and pain is so horrible - I am sensitive to medication, I should have prepared for this when I heard they were taking the brand name pills off the market. I will try to get through and talk with my doc on Tuesday. If I can't make it, one of the local clinics responded to my inquiry so I have them as a last resort if I need them. Thank you everyone. REPORT YOUR SIDE EFFECTS TO FDA!!
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Unread 05-26-2013, 02:22 PM   #7
OutOfOurBoxes
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Hi classicstyle Im sorry,, I didn't actually get to read your whole message (from last night/early this morn) until just now. Anyway it seems your questions were answered from Nancy. She is the first person I would take advice from on any of these topics anyway. I still wanted to respond. I would definitely say the film's would fix your issue's, especially if you were good on the film's before switching to the generic (yeah its definitely not just you). Because I was switched from the suboxone tablets to the generic a couple months ago and had nothing but issues with it. I went back to the suboxone tablets after a month of the generic and what a difference it made.. I don't think it was just withdrawal for me though, I also think it was a reaction from that filler (not 100% about that), but I do think withdrawal was definitely present as well.. I was very upset because I was looking forward to being able to pay less, but for now I guess I'm gonna have to stick to the name brand tablets, at least until they run out... I hope it all works out for you and that you make it through these next few days with as little pain as possible. sending positive thoughts/prayers your way .

Dre
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Unread 05-26-2013, 02:41 PM   #8
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I have not had experience with the generic subs but I can tell you a story about topomax which is anti depressant /seizure med/ migraine med. I was on this in 2003, had great results. Started taking it again in 2011, got withdrawals, brain zaps, couldn't figure it out then realized they had me on the generic . I have to pay about 45$ more per month for the regular drug but the difference is amazing. My first doctor didn't believe me and I had to say I was allergic to it but another girl I knew was taking the generic and she had the same results. Generics are sometimes equal to the real thing and sometimes they aren't
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Unread 05-28-2013, 03:24 PM   #9
ClassicStyle
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Hello Everyone, Original poster here:

I just wanted to give you an update on my situation. I was able to contact my doctor today and I told him that my insurance company had substituted the Generic Suboxone/ Naloxone Tablets for the name Brand Suboxone Tablets. I explained to him that the genetic was not working and that I am very sick with Nausea, severe leg cramps, no sleep, vomiting and chills - he agreed that the Generic must not be the same strength as the brand Suboxone. He has given me a prescription for the Suboxone Brand Film. Thank Goodness. I have experienced this generic vs. Brand name drug thing with other medications - unfortunately, my insurance company mandates that if there is a generic available, I have to use it - or pay the difference in price. Thankfully I have a wonderful doctor. Have they come out with a generic on the film yet? I received the brand name film today without any problem. How soon is that generic film thing happening? My doc will just have to make sure on all future prescriptions that he indicates that I have a negative reaction to the generic - he can write no substitutions on the script, hopefully the insurance company will not make me pay the difference when he indicates that I can't take the generic. Thank you everyone for your support. I'm on my way back to feeling well again, it will take a few days - but I am GRATEFUL!
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Unread 05-28-2013, 04:58 PM   #10
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hi ClassicStyle,
Thanks for posting about your expireince. Technically, there is no generic substitute for the film, (the tablets are not considered generic equivalents of the film) so hopefully your insurance will cover it. I don’t know of any generic film in the pipeline but there is a competing brand name film-like version in the works- here’s a link- http://www.naabt.org/buprenorphine_pipeline.cfm

Not sure if you know but you can save up to $50 off the film by downloading the card at Suboxone.com

Tim
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Unread 05-28-2013, 05:42 PM   #11
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Quote:
Originally Posted by bizzby45 View Post
I have not had experience with the generic subs but I can tell you a story about topomax which is anti depressant /seizure med/ migraine med. I was on this in 2003, had great results. Started taking it again in 2011, got withdrawals, brain zaps, couldn't figure it out then realized they had me on the generic . I have to pay about 45$ more per month for the regular drug but the difference is amazing. My first doctor didn't believe me and I had to say I was allergic to it but another girl I knew was taking the generic and she had the same results. Generics are sometimes equal to the real thing and sometimes they aren't
My mother takes Topomax but they give it to her for Fibromyalgia, it caused her to lose a TON of weight. It flubbed up some of her taste and she couldn't eat anything sweet or drink any pop for about a month or two. I tried it myself, I hated the crap. It didn't do anything but kill the taste of my Pepsi and one of my addictions that I will NOT get rid of is my Pepsi addiction. I figure that if I wanted to lose some weight although I was on it for Fibro, I will try something else. It really did help her with weight loss though. She dropped it like mad. Im thinking about going on a diet pill or something when Allen goes back to the doctor. He cant seem to get rid of Bronchitis.
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Unread 05-29-2013, 01:57 PM   #12
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Quote:
Originally Posted by ClassicStyle View Post
Hello Everyone, Original poster here:

I just wanted to give you an update on my situation. I was able to contact my doctor today and I told him that my insurance company had substituted the Generic Suboxone/ Naloxone Tablets for the name Brand Suboxone Tablets. I explained to him that the genetic was not working and that I am very sick with Nausea, severe leg cramps, no sleep, vomiting and chills - he agreed that the Generic must not be the same strength as the brand Suboxone. He has given me a prescription for the Suboxone Brand Film. Thank Goodness. I have experienced this generic vs. Brand name drug thing with other medications - unfortunately, my insurance company mandates that if there is a generic available, I have to use it - or pay the difference in price. Thankfully I have a wonderful doctor. Have they come out with a generic on the film yet? I received the brand name film today without any problem. How soon is that generic film thing happening? My doc will just have to make sure on all future prescriptions that he indicates that I have a negative reaction to the generic - he can write no substitutions on the script, hopefully the insurance company will not make me pay the difference when he indicates that I can't take the generic. Thank you everyone for your support. I'm on my way back to feeling well again, it will take a few days - but I am GRATEFUL!
Hi ClassicStyle, that's great that your doctor gave you a new prescription. Did you check your insurance company website to see if there's any way for your doctor to let them know that you cannot take anything except for the film? Maybe a dispute form or a pre-authorization form? Did you have to pay anything when you picked it up yesterday?

Nancy
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Unread 05-29-2013, 09:39 PM   #13
ClassicStyle
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Hello Nancy:

The prescription for the film was considered a new prescription - so I only had to pay the brand-name co-payment. I should be safe until they come out with a generic equivalent to the film. Thank you for your support.
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Unread 05-30-2013, 07:38 AM   #14
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Hi ClassicStyle, thanks for clarifying that for me. I misunderstood and thought the insurance company wasn't going to pay for the films because the generic tablet is basically the same medication but in a different form. PHEW!

There's no generic film that we've heard of. There's another film-like product by BDSI -BUNAVAIL - that's a film but it will go on the inside of the cheek rather than under the tongue, so it won't be considered a generic nor a replacement for the Suboxone film. Here's a thread on that:
http://www.addictionsurvivors.org/vb...ad.php?t=26952

Nancy
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Unread 07-22-2015, 12:38 AM   #15
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Hello all, I just wanted to chime in as I am researching this very topic myself. I have been on Bup for almost 7-8 years now. I feel fine with about 8 mg a day, because of chronic pain I supplement with allot of IBprofen. Anyway, recently my generic Bup which was white and made by Roxane, was changed to another generic by the pharmmacy, it is the Actavis version. Well, lately my legs have been hurting so bad, almost like the good ole days, I mean just heavy pain, so I was wondering whats up,maybe they are going on the cheap and cutting corners somewhere. Seems as if at least a few others are reporting problems. I will read the rest of the replies, but I am wondering if I can just ell the pharmacy I need the original one. I don't want to make waves, I feel grateful for what I have, but it seems to not work. On the up side if it is weaker , maybe it will help me get off. LOL!!!
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Unread 07-23-2015, 07:54 AM   #16
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Hi sub-standard, you could ask the pharmacy if they can order from Roxane instead. If they can't, call around and see if you can find a pharmacy who can.

We've had varying reports of the different generic 'tex manufacturers. Here are a couple of different threads if you hadn't seen them:
http://www.addictionsurvivors.org/vb...ad.php?t=29792
http://www.addictionsurvivors.org/vb...ad.php?t=28908

Have you tried splitting your dose to 2mg every 4 hours to see if that helps more with pain? The analgesic property of bupe last from 4 to 6 hours, so that has helped people with pain issues.

Let us know what you find out when you have a chance.

Nancy
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Unread 07-24-2015, 05:12 PM   #17
shea2617
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Default Bad generics

I'm glad I am not the only one having issues with generic suboxone tabs I would not have known the difference I was originally on subutex and switched over to the suboxone tabs was given generic Roxanne labs having serious issues I reported to the fda and anyone else who is having issues do the same please or they can't make them fix the problem. We all have a voice and a right to speak up when something is wrong. Don't be afraid or ashamed. It's your life your friends loved ones. This can make someone relapse believe me I was there at the brink from this.
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Unread 07-28-2015, 04:24 PM   #18
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Hope u get the help u need and that everything works out for u God bless
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Unread 07-31-2015, 12:20 AM   #19
shea2617
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For those having issues with generics ask your doctor to daw despensen as written on your prescription sometimes insurance company have to honor it
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