ineffectiveness of GENERIC ORANGE suboxone (amneal)

[<eNdOrPhInS>]

Hello,

While technically I am new here, I'm only new to making an account. I have been visiting this forum for years and have learned a great deal of harm reduction and safer techniques of doing things. As well as countless tips and tricks that have proven effective time and time again. I have even come to learn users screen names and am able to distinguish the ones here who hold a great deal of credible knowledge.

I am here to bring attention to the poor quality of the generic orange suboxones made by Amneal pharmacudicals. Not the white tablets with a crescent moon logo, those seem to work just fine. I am talking about the ROUND, ORANGE tablets that are marked "AN415".

I have years of experience with suboxone and got my first script back in 2005, when they were still classified an "IND" (investigational new drug) and nobody had a clue as to what they were. To date, I have come to learn and understand a great deal about buprenorphine and the way it works on the brain. I am a strong supporter of these pills and believe that millions are now able to maintain a better lifestyle with the help of buprenorphine. >snip<

A simple google search of generic suboxone will yield a vast amount of information regarding unsatisfied patients that noticed a change in quality of these tablets so naturally, I did my best to avoid them. I have taken almost all >other< forms of buprenorphine >snip< and have had no problems with them at all. >snip< Guidelines set by the FDA state that a generic product must contain between 80%-125% of the active ingredients in their brand name counter parts. I'm not sure if Amneal even met the 80% mark with these.

A few days ago I obtained these generic orange suboxone tablets for the first time because it was all the pharmacy had and I had no other options at the time to visit another pharmacy that I am registered at. After dosing, I absolutely noticed the difference in quality and I was not happy at all. This was not a placebo effect and not human error. >snip<

I became upset with this company and decided to do some research, >snip< >I am of the opinion< this company is using the absolute lowest level of buprenorphine or even a poorly synthesized compound in their tablets. >If this is the case then it< puts peoples sobriety at risk >snip<

I decided to write them an email and they replied the next day asking for more information. They also would like other patients with similar experiences to come forward. Below I have C&P'd my email and their reply, and as you can see, perhaps they might do something to fix this error. Here are the email addresses I used to write to them-

>snip<

If there is anyone here that is also experiencing lower quality standards with these generic orange suboxones and would like to take part in this complaint, like the email says, then please write to these guys. >taking your time to do this may encourage the company to seriously check it this claim and fix anything that needs to be<

MY EMAIL TO THEM-

E
Jun 26 (2 days ago)

to DrugSafety
Your generic version of suboxone is no doubt absolute garbage. Your company must use the lowest formulation standard possible to get these on the market.

Every suboxone patient I have spoke to all say the same about your version of the medication. People are having to double their intake and their sobriety is put at risk >snip<
This is not something as simple as Tylenol or multi-vitamins, this is a life saving pharmaceutical that is helping people remain clean and opiate free. And lets not forget how many families are affected everyday by the devastating effects of opiate addiction, and how many lives are lost by this unfortunate epidemic.

Nobody wants your version of the pill and I encourage everyone I talk to, to tell their doctors to switch them over to >another brand of the drug<

I guarantee that your generic version of suboxone will not last long at all on the market when nobody wants it.

This demonstrates >a need to take seriously these widespread claims<

Once again, I will be sure to urge everyone I know to talk to their doctors about the extreme and noticeable difference with your version of generic suboxone, and do what I can to spread the message as far and wide as possible, because I strongly believe that individuals maintaining a clean and sober life away from opiate addiction is >monumentally< important >snip< .

REPLY EMAIL I GOT FROM THEM

Dear Mr. E

Thank you for your below email correspondence Amneal received on June 27, 2013 reporting your experience of ineffectiveness (product is not good as others), regarding the product Buprenorphine HCl & Naloxone HCl Dihydrate Sublingual Tablets (generic Suboxone).

We would also like to mention here that this product - Buprenorphine HCl & Naloxone HCl Dihydrate Sublingual Tablets are manufactured at our US FDA (Food and Drug Administration) approved facility located in New York, under full current Good Manufacturing Practices in accordance with the product manufacturing instructions along with stringent production and quality control. Amneal’s Buprenorphine HCl & Naloxone HCl Dihydrate Sublingual Tablets product is therapeutically equivalent to the Suboxone Sublingual Tablets (brand). We recommend you to inform your healthcare provider regarding your experience and to discuss/determine the appropriate strength/dosage for your prescription, as it may require and to meet the individual patient needs for your treatment and the drug therapy.


On the basis of this reported information, we are initiating an adverse drug event report and are proceeding accordingly as per our requirements. Therefore, we are kindly requesting you to further provide us with the following information:

- Product Information – (any if available with you): “mg” strength of the product, imprints on the tablets, name and contact information for the dispensing pharmacy, date the prescription was filled, prescription number, and your permission for Amneal to contact your dispensing pharmacy for further product information such as, NDC number, lot number and expiration date associated with the prescription. This information will facilitate the completion of this investigation. Should this information is available with you, please advice us accordingly.
- Product Sample availability Information: Please advise whether you have a sample of the product in question available with you and the likelihood of providing us with a sample, since we would like to have them tested by our quality control laboratory. Please notify us accordingly whether or not a sample can be provided. If available for return, we will provide a FedEx prepaid mailer to your mailing address (please provide information of such) for this return.
- We are also kindly requesting some basic information about yourself – age, date of birth, weight, race, existing medical conditions (if any), and list of medical products taking (if any), any smoking habits, alcohol use, and any recreational drug use. Please inform us the date started the prescription and the date stopped taking the prescription (if applicable), along with the indication this drug was prescribed for you. Please provide the date (approximate time period if exact date is unknown) when started noticing the problem. In addition and for your convenience, we are enclosing the “adverse drug experience information” form for your completion.

Further, you had also indicated in the below email (see highlighted information below) regarding other Suboxone patient(s) where they had similar experience like you with the product - Buprenorphine HCl & Naloxone HCl Dihydrate Sublingual Tablets. Therefore, if these patient(s) are known to you, we are kindly requesting either obtain their consent in order to release their name and contact information to Amneal so that we can directly coordinate with them in obtaining further information (as mentioned above) pertaining to this report and also availability of a sample of the product. You can also provide our direct contact information (see email signature for contact details) to these patient(s) as well and if they prefer they can contact us directly.

Any information provided to this file will be handled with confidentiality as per the regulations and will assist us to effectively complete this investigation and file a MedWatch report to the Food and Drug Administration. If you prefer to provide the information via phone instead of completing the attached form, we can be reached via phone: (631) 656-5063, fax: 631.656.7573 or you can reply to this email.

If you have an easy internet access we would encourage you to please visit the BTOD REMS website at www.btodrems.com which provides detailed information on the BTOD REMS program and documents that you can download for your use. You can also our website www.amneal.com and search for this product in the product catalog where you would be able to gather more information along with the product labeling information for Buprenorphine HCl & Naloxone HCl Dihydrate Sublingual Tablets.

Upon completion of this report, a response letter will be sent to your attention with the findings of this investigation.

Thank you for bringing this matter to our attention and we apologize for any inconvenience. Should you have any further questions or concerns, please do not hesitate to contact us.

Sincerely,

Shweta G. Sharma | Drug Safety Specialist | Amneal Pharmaceuticals of NY, LLC |
[email protected]

 

[soniciso]

i used to be on the strips from july 2012 to november 2012... (i dont think there is a generic for the strips) i fell off the wagon for a bit getting up to a brick a day (yes 50 pieces a day)... as of yesterday i got prescribed the orange amneal tablets (the orange taste is actually more tollerable than the strips imo) they seem to be working fine in my case thats for sure. the hospital was forcing me to detox using clonadine and some muscle relaxers etc... the cravings were horrific when i got out to the point of relapse these generic pills are working for me with no problems what so ever! my cravings are gone thats for sure. i guess you need to get over the fact that this medication is made to take away your cravings and not give you a "high". back last summer i was on subutex... all that shit did was get me to take the subutex and get high on top of it! if you guys really wanna get off the H train... i really suggest suboxone in any form (strip tab or generic!) remember along with kicking the dope it makes it so if you do try you either get no pleasure or get sick from the opiates. <--- the thought of getting sick is what keeps me in tab!

 

[Mth1974]

I have had every form as well and I find that the Amneal generic is much better than the white ones that are like sucking on Bayer aspirin. I am a recovering addict of every drug known to man and have been clean for nearly 7 years. Suboxone has been found to give me relief of the permanent injuries suffered from a gun shot wound I took in the back in 2003. Much less riskier than the crazy amounts of fentynol and OxyContin my dope dealing doctors got me wrapped up in. I'm having an issue actually finding pharmacies that carry the amneal and have been told it's on back order. As a result, I'm stuck with these butt awful white things I have to choke down twice a day. I happen to be a substance abuse Therapist of 5 years and I believe 100% this is nothing but a witch hunt that the street pharmacists are feeding off of. I witness them spreading their expertise every day on our Detox Ward. People who seem to always know more than the actual doctors but somehow always find their way back to Rehab. I was no better. We need to stop victimizing ourselves and justifying relapse. The thought of people actually blaming Amneal for near relapse is a classic example.<snip>

 

[cwimmer205]

IMHO, The orange Amneal 8/2 bupe/nal are practically on spot equivalent or the closest to brand Suboxone (discontinued tabs). The actavis were sadly disappointing with the white 8/2 seemed to be on the lower side regarding strength, and duration. I also was able to try Zubsolv 5.7/1.4 bupe/nal (alternative to Suboxone, suppose to be for long term maintenance, keep the same plasma concentration the same as Suboxone, while being less than the overall dose but somewhat different delivering mechanism [smaller and a eucaltyptus like mint flavor]). In the induction, and if you were starting with that it's a little bit hard to tell the difference at first but they are about literally their mg dosage regardless of plasma concentration effects wise (about 3/4 of a Suboxone or equivalent [possibly less]). Going from Zubsolv to Amneals bupe/nal generic was a major change. It felt like I was almost getting an extra dose a day after switching. I have tried all forms, mostly cause of cost, then insurance, and finally discontinuating brand forms. I know I left out strips, but its almost a complete different ballpark. The strips work, but they can be so different at times. It's really important if your gonna be on these long term that you find what works for you, AND your overall recovery if there is one. I didn't start out with one, but I do now have long-term goals concerning my drug use vs control. I also used Subutex, and generic buperenorphine 8mg tabs. I honestly dont notice a huge difference. But I don't mix opiates,but some do with them and claim the higher affinity doesn't matter. They are easier to divert, so if your truly taking them to stay clean you really gotta trust yourself. They are considered the gold standard on the street and I don't understand it. I used buprenorphine for a very long time and switching in between them only mattered if I wasn't doing what I was suppose to and not caring about the long term road on bupe. I stick with my bupe/nal 8/2 Amneals mainly because of how they work, and they are very good to manage in with my other recovery visit costs. (Don't know if this is allowed, if not I can edit) with GoodRx, there is only about a 20 dollar difference (Amneal bup/nal vs Roxanne bupe). About the effectiveness though, that was my opinion, you will hear different ones swearing by the exact opposite but if you truly feel screwed, do something to fix it like the OP. If it doesn't work significantly (especially within allowed margins, get switched; if your Dr insists without exception try it, but you have every right to be on a medicine that works, and is affordable.) The pharmacy by law can't always just 'take back medication' so don't commit and be stuck the whole month.
Seriously though, if you have not already discovered GoodRx (app avaiable, and website www.goodrx.com) you need to, I save 60% now on the Amneals.

NSA: EDIT in the name of harm reduction I think this link should be left. It often provides a significant savings on many medications and is free to use. Given the struggle that many addicts face in affording this medication I feal this could prevent harm. I have also used this service and have nothing but really positive things to say about it. If you are having trouble paying for any medication I would check it out.

 

[dadclock62]

Although I agree with your findings, I do not agree in writing the company with MY private information. I believe this would be like opening a can of worms allowing the company and who knows who else to obtain and maybe use that information any way they would like=but Thank you very much for your info

 

[Captain.Heroin]

All generics should be just as viable as the brand name products they imitate.

 

[1800-GOT-JUNK]

I have had just about every type of suboxone and subutex available over the last many years. Stop signs, strips, crescent moons and yes, the anmeal orange rounds. I've found them to be comparable to all other forms and haven't had any complaints with them. My favorite is obviously subutex because I can slam it and get a nice high if I'm sufficiently withdrawing. However, that's also the reason I avoid subutex like the plague; the temptation is too much. I've been taking the orange rounds you describe for about a month with no discernible difference in effectiveness. Might i suggest that it is a placebo effect based on your pre-conceived notions from reading about other people's bad experiences?

 

[Jabberwocky]

I have had just about every type of suboxone and subutex available over the last many years. Stop signs, strips, crescent moons and yes, the anmeal orange rounds. I've found them to be comparable to all other forms and haven't had any complaints with them. My favorite is obviously subutex because I can slam it and get a nice high if I'm sufficiently withdrawing. However, that's also the reason I avoid subutex like the plague; the temptation is too much. I've been taking the orange rounds you describe for about a month with no discernible difference in effectiveness. Might i suggest that it is a placebo effect based on your pre-conceived notions from reading about other people's bad experiences?

I have had very similar such experiences.