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FDA finally put black box warning on all benzodiazepines


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At least we have something to take to health care providers when they don’t believe us! This is a huge win, I have had nurses and doctors in psych wards shame and gaslight me, they don’t listen to patients much. Now we can print this out and walk in with it. Better than the nothing we had before and some doctors do care and will read this and it will make a difference. Of course it doesn’t 100% solve this problem, IMO benzodiazepines should be wiped from the face of the earth. But, it’s progress and better than I thought we would see.

 

Also the warning about the addictive nature and encouraging doctors to actually pay attention to that is important, even if many of us struggled with dependence not abuse. Just because someone has the disease of addiction and not just a dependence doesn’t make them less worthy of good care. Stop getting offended and consider yourself lucky if you don’t. These drugs are widely misused and abused and wreak havoc in those people’s lives too. You are not superior to them because you don’t have the disease of addiction, just different.

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That's correct, it doesn't matter if you're addicted or not or if they're prescribed or not, either way it's the same medication going in your body. I don't know why they see the two as being any different, when the reality is you're taking the pill and you're placing it in your mouth and swallowing it with water, so what's the difference?

 

Or you can think about it like this, you could do a test and compare two people side by side. The first person takes 8 tablets a day as prescribed, and the second person takes 8 tablets a day non-prescribed off the street. When you remove the medications from them in a couple years, they're both going to go through the same withdrawal. So did the prescription matter for the one person? No, it doesn't.

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[c5...]
Benzos aren't dopaminergic drugs. Very, very few people are actually addicted to them (I know of only 3 people total on the forum that can be said to be addicted). As such, the whole addiction schtick is just used as a bludgeon to mistreat people. Of course, I agree that addicts shouldn't be mistreated, but it is what it is. They do get stigmatized and mistreated, and this is especially horrible for someone who got put on the drug by a physician and then forced into "detox" center and into cold-turkey.
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No one is arguing that they don’t use the label of addict to mistreat people and deny proper care. Your points about the number of people who are addicted based on your false understanding of the disease and your observations of how many you have decided are ‘truly addicted’ on this forum, are gravely misinformed and honestly, just arrogant. Many addicts obtain these drugs legally from doctors, I’ve seen them come through the many medical practices I’ve worked in, since we are being anecdotal now.
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[c5...]
I'm not basing my argument of who's addicted on where one gets benzos from. Self-medication isn't addiction. Addiction is using benzos to get "high" instead of for therapeutical effect and my obervation is based on the number of people on the forum who admitted to benzo abuse, and they're usually dependent on large doses (like 300+ mg diazepam equivalent). But that is all beside the point. People dependent on antidepressants, antipsychotics, or even gabapentoids aren't stigmatized as addicts (and gabapentoids are known to be much better for getting "high" than benzos, heck phenibut drug much more dangerous than benzos is treated as merely a "supplement"). Addiction is mentioned only with regards to benzos. The whole legal environment about all of this is bizarre even without taking benzos into account, e.g. mCPP the metabolite of trazodone is illegal, whereas trazodone itself is legal. So, if you take trazodone you end up with illegal substance in your body.
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Benzos aren't dopaminergic drugs.

 

FYI Stanford Psychiatrist Anna Lembke shares her opinion about dopamine and benzodiazepines in the video clip below.

 

Benzodiazepine Withdrawal Difficulties: Stanford Psychiatrist Anna Lembke, M.D.

Medicating Normal

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[c5...]

FYI Stanford Psychiatrist Anna Lembke shares her opinion about dopamine and benzodiazepines in the video clip below.

Yeah, I know that video. Brainfart on her part. She casually blurted it out as if benzos are amphetamines. There's limited anecdotal evidence benzos cause dopamine rush and euphoria for some people (that's why benzos are stimulating for those people), but for vast majority they don't. That's why most people aren't dependent on 300+ mg of diazepam or equivalent, and why most people don't feel any sort of craving for benzos. Dopaminergic drugs and activities cause intense cravings however, stuff like porn, gambling, sugar, meth... and that is what fits the addiction criteria.

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That's a good point, it's like the primidone that I take, it metabolizes into phenobarbital. Phenobarbital is controlled, and primidone is not.

 

So whenever I take a urine test, I test positive for barbiturates. But the thing is, primidone does not make you feel like phenobarbital. And once this withdrawal process is over, I'm going to quit taking it.

 

So basically, legal or not, and prescribed or not, doesn't make a difference. Neither does addiction, makes no difference with benzos. Either you're screwed or you're not. And either you've got withdrawal or you don't.

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My doctor says that I'm a drug addict, and that I'm recovering from addiction because I'm still going through benzo withdrawal. Prior to stopping the benzos, she only said I had a neurological condition that required medicine. So yes, the words they use can be really negative. Aside from that, it doesn't change anything.

 

At least in my mind, it's all the same. Because it's like right now, whether I'm a drug addict or not, I'm going to be bed bound with agoraphobia trying to heal for the next couple years. My finances will be the same regardless of my label. And the medical attention and doctors I go to will be the same regardless.

 

And for the people that don't think they were ever addicted, why did they have several failed attempts at quiting? If they were not addicted, they should have just stayed off of them. But we all know, it's a severe addiction. You can get addicted within the first couple days.

 

Or think of it like this, let's say it was a street drug instead of a prescription drug. If somebody took them a couple times and felt good, and then decided they would take them for another week or two, and then all of a sudden can't get off, what else would you call it? I'm pretty sure that would be called addiction. A prescription doesn't make it any different other than legal or not. It doesn't have to give you Euphoria to feel good.

 

At the same time, I have wondered myself is it just physical dependence and not addiction at all? I guess that's completely possible too. Like for example, maybe they use the word Addiction on everything that you do repetitively for no reason. Maybe they shouldn't use the word Addiction with things like food and benzos and gambling, because it doesn't get you high. So maybe the word and term addiction is overused.

 

But that's getting technical. At the end of the day, the only thing that matters is did you get off of the benzos and stay off of them like you want? And are you getting yourself better and happy with your life? If so, and you're healthy, it really doesn't matter what the label is. And I don't think there's anything wrong with being a drug addict other than the suffering and financial issues and legal problems that come along with it. And sometimes some bad things happen.

 

Maybe if Society didn't make out drug addicts to be bad people, people wouldn't be having this debate on benzo buddies nonstop. Everybody has the immediate denial of being one and gets all worked up for no reason. It doesn't even matter, just get yourself better.

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My point has nothing to do with good or bad, labels, or whateva.. Its about the right treatment protocols and correct support for each situation..

 

Like not being escalated up in dose because Drs clearly see one ISNT an addict/ed, but dont understand the severity of tolerance and physical dependence.. (oh it must be increasing pain, or anxiety, or insomnia, or whateva.. -Take more..). Furthermore, through denial of WD SX (the dependence) I have seen it lead to unnecessary surgical procedures and worse..

 

Then later or alternately, -“Its addiction”, -thus detox, CT, and “rehab” will solve the problem..

That just left me protracted, polydrugged, and counting new losses daily..

 

Im not here to dictate anyones situation, but no one can tell me language and its understanding cant impact treatment protocols, and that treatment protocols dont correlate with the “experience” or outcome...

 

Perhaps if one is maintaining a CT then it’s a moot point by then, the (potential) damage is already done, assuming we are talking about a tolerance or physical dependence situation..  Were is solely an addiction situation, then great, one as well on their way to healing or perhaps a sobriety..

 

But what if its both.. -Thats where it gets tricky I guess.. One would have to decide what takes precedent, if things like dose management cant be maintained through a taper..

 

If one doesnt believe tapers of varying and personal length are “best practice”, then thats another story... -Hopefully one without a strong physical dependence involved..

 

At a personal level, -whatever works and gets one through is fine by me.. My concern is the bigger, broader picture where language affects treatment...

-as explained in the above link..

 

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[c5...]

And for the people that don't think they were ever addicted, why did they have several failed attempts at quiting? If they were not addicted, they should have just stayed off of them. But we all know, it's a severe addiction. You can get addicted within the first couple days.

The difference between addiction and dependence can be shown by an example. Say you're addicted to porn. If you don't get your porn what'll happen to you? Nothing. If you're dependent on benzos and don't get your benzo you'll suffer horrific withdrawal symptoms, and might even get a seizure and die. Of course, there are drugs that cause both addiction and physical dependence, like Adderall, bupropion, opiates, etc. but benzos themselves are more like beta-blockers, or even antihistamines in that they create physical dependence, not cravings.

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Dear All - havne't been on this site in a long time but wanted to share the below - since i work in the pharmaceutical industry and manage FDA interactions - i receive these alerts - to receive a black box warning is a very significant consequence - sadly - not sure it will deter doctors from continuing to give these meds out like candy - but it means our voices are starting to be heard.

 

U.S. Food and Drug Administration <usfda@public.govdelivery.com>

Wed 9/23/2020 4:01 PM

 

 



Boxed Warning Updated to Improve Safe Use

MedWatch Header Pharmacy

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

 

TOPIC: Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use

 

AUDIENCE: Patient, Health Professional, Pharmacy

 

ISSUE: The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other information to the prescribing information for all benzodiazepine medicines. This information will describe the risks of abuse, misuse, addiction, physical dependence, and withdrawal reactions consistently across all the medicines in the class. The FDA is also requiring updates to the existing patient Medication Guides to help educate patients and caregivers about these risks.

 

Other changes are also being required to several sections of the prescribing information, including to the Warnings and Precautions, Drug Abuse and Dependence, and Patient Counseling Information sections.

 

BACKGROUND: Benzodiazepines are a class of medicines approved to treat generalized anxiety disorder, insomnia, seizures, social phobia, and panic disorder.

 

RECOMMENDATION:

 

Health Care Professionals

 

Consider the patient’s condition and the other medicines being taken, and assess the risk of abuse, misuse, and addiction.

Limit the dosage and duration of each medicine to the minimum needed to achieve the desired clinical effect when prescribing benzodiazepines, alone or in combination with other medicines.

Use a gradual taper to reduce the dosage or to discontinue benzodiazepines to reduce the risk of acute withdrawal reactions.

Take precautions when benzodiazepines are used in combination with opioid addiction medications.

Patients, Parents, and Caregivers

 

Always tell your health care professionals about all the prescription and over-the-counter (OTC) medicines you are taking or any other substances you are using, including alcohol.

Take benzodiazepines and all medicines exactly as prescribed by your health care professional

Discuss a plan for slowly decreasing the dose and frequency of your benzodiazepine(s) with your health care professional.

Contact your health care professional if you experience withdrawal symptoms or your medical condition worsens.

Go to an emergency room or call 911 if you have trouble breathing or other serious side effects such as seizures.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

 

Complete and submit the report online.

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Wow!

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That's not good at all. It says that the patients were solicited by the benzo information coalition. It also says that the patients don't have knowledge and doctors don't back up what we say.

 

So basically they are saying that we are idiots and didn't discontinue our meds properly and that's why we're having extended withdrawal.

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That's not good at all. It says that the patients were solicited by the benzo information coalition. It also says that the patients don't have knowledge and doctors don't back up what we say.

 

So basically they are saying that we are idiots and didn't discontinue our meds properly and that's why we're having extended withdrawal.

 

What? That's not what they said at all. Did you read the 177 page report, or just skimmed the blog? Or neither?

 

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This is the part that I read right here...

 

"DPV conducted a search of FAERS and completed a pharmacovigilance memorandum in January 2018 in response to an observed increase in benzodiazepine AE reports submitted by patients describing prolonged symptoms after benzodiazepine withdrawal and failed attempts at discontinuation of benzodiazepines [3]. DPV found that this increase in reporting was likely due to an online call to action by the Benzodiazepine Information Coalition soliciting all patients injured by benzodiazepines to report their experiences to the FDA. However, DPV also identified several themes in the FAERS reports, including: lack of physician education/knowledge regarding benzodiazepine prescribing, lack of patient education by the physician at the time of prescribing, or a prescribed tapering schedule that did not prevent withdrawal symptoms (i.e. taper was too rapid)."

 

I don't know what that is or where it's from, but it makes us sound stupid because of whatever dpv stuff is.

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This is the part that I read right here...

 

"DPV conducted a search of FAERS and completed a pharmacovigilance memorandum in January 2018 in response to an observed increase in benzodiazepine AE reports submitted by patients describing prolonged symptoms after benzodiazepine withdrawal and failed attempts at discontinuation of benzodiazepines [3]. DPV found that this increase in reporting was likely due to an online call to action by the Benzodiazepine Information Coalition soliciting all patients injured by benzodiazepines to report their experiences to the FDA. However, DPV also identified several themes in the FAERS reports, including: lack of physician education/knowledge regarding benzodiazepine prescribing, lack of patient education by the physician at the time of prescribing, or a prescribed tapering schedule that did not prevent withdrawal symptoms (i.e. taper was too rapid)."

 

I don't know what that is or where it's from, but it makes us sound stupid because of whatever dpv stuff is.

 

DPV = Division of Pharmacovigilance. I don't agree that the FDA saying "all patients injured by benzodiazepines" or "lack of physician education/knowledge regarding benzodiazepine prescribing, lack of patient education by the physician at the time of prescribing, or a prescribed tapering schedule that did not prevent withdrawal symptoms" makes us sound stupid. There's a ton to say about this 177 page report. I do not think the FDA itself understands what a safe taper entails after reading it.

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Well the first thing that I saw was that we are basically some random group of people that was told by benzo information coalition to put in a med watch report and we did. But then it also says that we were not educated basically. And that probably didn't do the taper correctly either. So that's not good. It makes us look uninformed and out to get the drug makers for no reason when we didn't do things correctly.

 

Maybe I'm taking the reading the wrong way, but that's what I got out of it. And I didn't read the rest of it so I can't speak for the rest. But it really doesn't matter because we are just people that took a product and if the doctors don't back us up then it doesn't matter.

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Well the first thing that I saw was that we are basically some random group of people that was told by benzo information coalition to put in a med watch report and we did. But then it also says that we were not educated basically. And that probably didn't do the taper correctly either. So that's not good. It makes us look uninformed and out to get the drug makers for no reason when we didn't do things correctly.

 

Maybe I'm taking the reading the wrong way, but that's what I got out of it. And I didn't read the rest of it so I can't speak for the rest. But it really doesn't matter because we are just people that took a product and if the doctors don't back us up then it doesn't matter.

 

I don't agree that's what it says or means. Best of luck.

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I haven't read the whole report, but from the snippets shared above, it looks like the FDA is mostly putting the onus on prescribers (doctors) for not having provided patients (us) with sufficient information, and for having put us on too-rapid tapering schedules.  I see this (what I've read of it) as a step in the right direction.  I am mostly angry that none of this was available to us when we were first prescribed the benzos, at least those of us who have been taking benzos for years. 

 

Haimona

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I haven't read the whole report, but from the snippets shared above, it looks like the FDA is mostly putting the onus on prescribers (doctors) for not having provided patients (us) with sufficient information, and for having put us on too-rapid tapering schedules.  I see this (what I've read of it) as a step in the right direction.  I am mostly angry that none of this was available to us when we were first prescribed the benzos, at least those of us who have been taking benzos for years. 

 

Haimona

 

I'm infuriated. I was prescribed in 2009. Even at that point they already had nearly 60 years to figure this out and they didn't. In the meantime, so many of us have lost years of our lives and suffered in unbelievably ways over lack of action. Some even lost our lives completely. I don't think the FDA even understands the problem after reading these reports, but I don't think they're blaming us or making us look dumb. I think they realize there are groups out there of harmed patients. There's also a lot of stats in the report that will be useful for campaigners, journalists, legislators, etc, both about prescribed and illegal/addiction/abuse problems. Unfortunately, they blacked out how many of these things are prescribed annually.

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I think that many people are getting this entirely wrong. You might think it doesn't go far enough - I certainly do - but the suggestion is that people become injured due to a lack of awareness surrounding benzos which is exactly right. The cause for this situation is rightly identified as unaware doctors. The measures described are designed to address this issue and it's hard to argue that this won't help. This will save some lives from being wrecked. I self-medicated with diazepam in desperation. I knew it was risky but in my desperation, I didn't look closely enough to evaluate the risk. I think this warning could have saved me from taking this path.

 

It's a good thing. It won't wipe out inappropriate benzo prescribing all together, but it's surely gonna help. I hope things look better in 10 years time, when some old dinosaur hack doctors leave the scene and the newer doctors weren't brought up to dish out benzos. Change usually happens by degrees, even though right-minded people can see that more substantial action is required. We have to be realistic. It's like this because of politics and money. That's a bigger problem than the benzo world and it ruins lives across the board. Yay predation!

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Things are definitely moving in the right direction, but it won't be anytime soon that things change. I would like to hope that they will, but I don't think they will anytime soon.

 

With me for example, they started prescribing them to me at 17 years old in 2001, and I didn't quit taking them until 20 years later. And the reason that they look at it like it's my fault, is because they told me not to take them more than a couple weeks. But the doctors decided it was a good idea regardless of what the manufacturer had to say and warned us about.

 

And they have been warning patients of not taking them longer than a couple weeks for decades. They've been notifying everybody about this info since way back in the day. This isn't new.

 

That's why they are controlled. It's because they are addictive and they have horrible withdrawal, and that's also why the pharmacies and manufacturers tell us not to take them long-term. Does that deter anybody? No it doesn't.

 

And now, everybody that has been injured wants to sit around and act like they were not given any warning and their lives are ruined and they didn't do anything wrong. When everybody here knows that it wasn't a good idea to take them long-term but did it anyways.

 

And if you read that article, it literally states that we are a big group of people trying to file a medwatch report because benzo coalition gave us the idea. Not that that means anything. The only thing that matters is what the doctor thinks is a good idea and prescribes.

 

The reality of life is that doctors are trained to make educated decisions and so society believes they're doing the right thing. So if we have a prescription, then that's because the doctor thought it was medically necessary. So if we did what the doctor thought was medically necessary, there's nothing wrong with that is the way that the legal system works.

 

And the reason we can't sue these companies is because they recommended never doing that in the first place. So they have already covered themselves from legal issues. That doesn't mean they didn't do anything wrong.

 

So there's a million different ways to look at this, but long story short, nobody was supposed to take them long term in the first place. And because we did, we are suffering. There's nothing that can change that.

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