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3 Answers
PR
Probenzo101
10 Aug 2024
The FDA does not adhere to their own rules and regulations, nor do they conduct nowhere even remotely close to the amount of inspections of manufacturing plants as was claimed in a comment on here from a couple years ago. I know this is an old thread but I’m certified in Pharmacology and Pharmacokinetics as well as have read every single case study, randomized controlled trials and even more in depth studies and statistical analysis data. I even have gotten to know the dark little secrets behind the extremely complex and highly disturbing nature behind the patent application process and more importantly, the virtually nonexistent and potentially dangerous generic drug application approval process.
First I’ll start with saying as of now, the name brand of Diazepam (Valium) by Roche is no longer available and there’s currently 555 different generic versions on the market for diazepam, Teva is not the same as of a few years back due to the acquisition of Actavis pharmaceuticals. Just looking at both the diazepam and the generic version of Klonopin (clonazepam) is blatantly clear that the company has made some changes. Most of the generic variants have the Teva name but they are using the Actavis brand of the generic drugs. For example the Teva clonazepam used to have Teva on one side and 833/834 on the back side followed by a line down the middle of the back side to score the tablets so that the patient is able to get an accurate dosage but the generic clonazepam has done away with the scored tablet and they have also changed in color ever so slightly and if you do a little more digging, the bioavailability of various generic versions vary widely. Ranging between 68-124% bioavailability, and what was once a small, yet still pretty significant difference in the amount of the active ingredient (80-120%) is now a much wider range where it can differ (40-100%) and as far as the audits are concerned, thanks to the increased volume of generic drugs that are coming in from other countries, companies are either paying hush money to continue to pass an audit or even proven instances where international audits are being conducted, they will either notify the manufacturers of the country a week or two prior to inspection which means that the company will have time to prepare forged documentation, get rid of any documents that prove cross contamination or sanitation issues and even china has even went so far as to give the auditors contaminated drinking water to avoid the inspection process altogether. This is the sad reality of the greedy and corrupt system that is making sure that the patients are “receiving the best possible medication that is up to their standards” or lack thereof. The one generic diazepam that I have taken recently that is even somewhat close to the name brand is DAN pharmaceuticals. And it’s not nearly as reliable as the brand name. Although I take Alprazolam mainly, but I have been prescribed benzodiazepines for almost two decades and have studied them extensively. Every single clinical trial, post marketing research, double blinded cross examinations and controlled trials, the amount of time spent on the trials, number of participants and the end result of each trial is engraved in my memory. Generics are not just one patient will react differently than others anymore. It’s much more complex and sinister. I would be happy to debate this with anyone who is confident enough to try me on this. I would also be happy and willing to share my sources and give advice if anyone is currently struggling with their generics or is interested in learning more please feel free to comment back, and I will be happy to share what I know and even guide you to the best way to get the information for yourself. I hope everyone has a safe and wonderful weekend ahead!
Votes: +0
WI
WildcatVet
10 Aug 2024
This might should be directed to professionals not impressionable non-professionals?
PR
Probenzo101
5 Nov 2024
“Impressionable non-professionals” is it? That’s very cute. Unfortunately for you, that’s not even remotely close to my actual profession. I notice that you seem to have quite the social media presence on here as well as other various platforms, virtually echoing the exact same ill informed and extremely naïve, potentially harmful responses. Though I don’t believe I need to explain why I am more than qualified to answer this question without a doubt but I will appease you if it helps you feel better about yourself, I’m a registered Pharm.D and have been in this field since 2007, my first position was at a local Fred’s pharmacy in Mississippi prior to the closing of said chains due to having to file for chapter 11 bankruptcy in September of 2019, am currently a pharmacy manager and have multiple small chain and one specialty pharmacy in the state of Tennessee.
So, I believe that I am more than qualified and capable of applying an adequate and appropriate answer to this question. So with all due respect, I would recommend that you please consider your words and opinions more carefully before making any further immediate accusations or smart remarks that’s very unprofessional and immature behavior. I personally don’t take any offense, that said there will be a time when you may end up saying the wrong thing to the wrong person(s) that might not have a sarcastic and open minded train of thought. I have an account on Quora where you can learn about my credentials as well as my very well versed and passionate experience with the pharmaceutical industry, the FDA “laws/restrictions/NDA/generic drug approval requirements, protocols and “”so called”” safety and efficacy standards” bioengineering, and the truth and omissions that are not being addressed with the public’s best interest in mind. So I am not looking for an apology since I don’t really care one way or the other what someone “believes” my capacity to answer questions about topics that are being addressed with the truth and the utmost love and concern for the patients who are suffering from this completely asinine and extremely dangerous game that the government, pharmaceutical companies and physicians are playing by manipulating the truth to lure patients into the false narrative that they are being treated and cared for, when it is actually the furthest thing from the truth and goes a lot deeper than you could ever imagine. I’m glad to see that this misunderstanding has been addressed. I implore you to do your research more thoroughly, and make sure you leave no stone unturned, and though you may not find everything I have due to various reasons I’m sure you are aware of, there’s enough “actual evidence” to support each and every point I’ve made. I don’t do this for clout and I am sure as heck not making any profit from spending time typing out these long and time consuming answers, but I genuinely believe that the people who are doing their best to make it, to get the most accurate and precise information possible in order to get the highest possible care and to avoid being entrapped in this potentially irreversible, even life threatening web of lies, corruption and abuse of power because I care. It’s as simple as that. And your responses aren’t completely inaccurate as there are still few physicians and pharmaceutical manufacturers that do adhere to the original FDA guidelines and not this new, “fast tracked” approach were the pharmaceutical companies are given an “incentive” for the swift marketing of either a NDA approved product or a generic product that is not currently available for a reference product. However, the competitive market floodgates that are allowing the consumer to purchase products that are marketed from other countries with no quality control measures, a overly broadened definition of quality and efficacy is both directly and indirectly resulting in a catastrophic amount of casualties in the short time it has been put into effect. My stance on this is absolute and I will not keep my knowledge and position on this matter under wraps until I start seeing results and mortality rates decline, unfortunately I don’t see any evidence of this happening in the near future. I apologize for my overly sensitive comment but this is a critical issue that needs to be addressed and made more widespread or not a single thing will be done, and it will continue to grow into something that the people will never recover from. I understand that you have the best interest of others in your mind as well. So please, do extensive and relentless focus and research and you’ll be able to understand my words. I mean no disrespect towards you. I hope you and your family have a wonderful week ahead.
BO
bobsy
4 Nov 2020
Just to answer your query, the Teva brand is a very good generic brand for benzos.
Votes: +0
WI
WildcatVet
13 Dec 2018
Hi, english! The difference between generics are the inert ingredients used as fillers and binders, so technically there should be no difference in efficacy unless the fillers slow or increase the rate of absorption. I won't take benzodiazepines, but many people here do and I'm sure they'll chime in with their experiences shortly. Best regards and good luck in your hunt!
Votes: +1
EN
englishsummerrain
13 Dec 2018
Thanks for your reply, I’m thinking that maybe my body just doesn’t like diazepam. I’m going to speak with my doctor soon to see what my alternatives are.
JW
jwtmmt080214
16 Jan 2020
Are generics are not equal. I am currently going through a very difficult time bc of this. The new generic I am on is no more than a sugar pill with bad side effects. I had been on my medication for over a decade, off and on, and they worked perfectly! All you have to do is a simple google search: other generic clonazepam not working like teva. Solco not working like teva clonazepam, accord not working as well as teva clonazepam etc etc etc. Do not let someone tell you it is in your head bc they are all the same, bc they aren't!!! I went in for a urine screen after I received my new mylan clonazepam. I was only about 3 days into my script, and I was telling my doctor, look this brand just isn't working for me. The new ones were throwing me into acute wd. While I was talking to my doctor, his nurse pulled him into the hallway, to notify him that I had no clonazepam in my system.
When he told me this, I said, "I believe it"! Tbh, I would be more shocked if i tested positive for benzos, bc right now, and for the last 3 days, I feel as though I have not had any benzo in my system! I said, "I need this medicine"! If it was working, I would be taking it and not saying a word! I pointed out how many yrs I had been on Teva, and that I not a once had a urine screen show that I wasn't taking my medication. I said, don't you think this is a pretty weird coincidence?? The first time I get a diff brand, all these issues arise. At this point he had no argument, but I wasn't going to let him have even a shred of doubt, that I hadn't taken my med, plus I didn't want that on my medical record. So I said, how bout this? I took my pill bottle out of my purse, and took a pill out. I showed him the front and the back of the pill so that he could see that it was indeed my clonazepam. I said, I will take this pill sitting right here with you to witness, (I even asked if his nurse could witness it as well.) I then told them what my availability would be the next day, so I could come in and do another urine screen. In front of my doctor, and his nurse I took the pill, and told them I would see them tomorrow. I went back in the following day and took my urine screen, and as I knew it would be, it was NEGATIVE for benzodiazepines!!! That had to be a good lesson for that doctor! I have been through every single other generic there is. Actavis is the best, but still sucks. With that being said, I am switching to Valium. This whole issue has left me so scared of getting bad generics in all my medications now. I guess pharmacies are just going the cheapest route at our expense.
WI
WildcatVet
16 Jan 2020
"FDA requires generic drugs to have the same active ingredient, strength, dosage form, and route of administration as the brand-name drug. The generic manufacturer must prove its drug is the same (bioequivalent) as the brand-name drug. All manufacturing, packaging, and testing sites must pass the same quality standards as those of brand-name drugs. Many generic drugs are made in the same manufacturing plants as the brand-name drugs." "A generic medicine works in the same way and provides the same clinical benefit as its brand-name version. This standard applies to all FDA-approved generic medicines. A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken and should be used. Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits as the brand-name medicines
Generic Drugs Fact Sheet Generic Drug Facts Handout (PDF -144KB) The FDA Generic Drugs Program conducts a rigorous review to make sure generic medicines meet these requirements. In addition, FDA conducts 3,500 inspections of manufacturing plants a year, ensuring compliance with the agency's regulations on good manufacturing practices." And yes, I do believe the FDA is not a figment of someone's imagination.
