FDA MEDWATCH PROGRAM

I think a possible reason for not filing is being in denial about being injured by a doctor's advice. These are painful realities.

I think a possible reason for not filing is being in denial about being injured by a doctor's advice. These are painful realities.

 

I haven’t filed a report to the FDA for quite awhile now. And I’m not in denial about being injured by a doctor at all. I am injured. I’ve been switched between different generics of clonazepam 6 times in the last 3 years.

 

This has affected my CNS tremendously and upsets me greatly. I feel that contacting the FDA about the dangers of benzos is a waste of my breath if the FDA will never acknowledge that there is great variability between generics of any benzo and great variability between people also.

 

If we are to constantly be “urged” to contact the FDA about these dangers, why are we not emphasizing these other important factors also?  I also strongly believe that the slow tapering as suits the person should be emphasized also.

 

So 4 things in my opinion  all of equal importance>>>>

 

Benzo dangers, Generic variability, Individual variability, Slow tapering as per the person involved.

 

If we are to inform people, doctors, and the FDA, lets really do the job full throttle.

 

I contacted the FDA by phone almost a year ago, and I was switched around to various departments until I was finally given to a pharmacist. She seemed completely uniformed about anything regarding benzos, was unable to navigate the FDA website, and when I asked about all the generic discontinuations, she said to me, “What discontinuation are you talking about? I see no discontinuations whatsoever.”

 

Please remember that we are dealing with bureaucracy here before anything else who just want a problem solved as fast as possible. So in my opinion once again, if we advocate for anything, do the whole “job” as one may  find themselves “pulled off” a benzo before they are even close to being safely off of it.

 

These are painful realities for me.

 

 

Just had to add that I’m fed up with these experts also as in Anna Lembke MD. She uses plenty of addiction language when speaking of benzos, and says quite frequently that these drugs should only be used for 2-4 weeks. I tend to think that we know that time frame by now and pretty much else she says also.

 

As far as addiction period, I do not crave this drug one iota. In fact, I dread even taking it. Just the thought of that repulses me.

 

 

 

 

 

 

Done

Done

 

Done? What does that mean?

 

You filed with the FDA? Or you’re done with the FDA?

 

Doesn’t make any sense to me at all.

Done

 

Done? What does that mean?

 

You filed with the FDA? Or you’re done with the FDA?

 

Doesn’t make any sense to me at all.

 

As I think about this again, I really don't care. I’m not going to be filing any reports or calling the FDA anytime soon if ever as it seems nothing and I mean nothing is ever accomplished!!!!

 

 

Done

 

Done? What does that mean?

 

You filed with the FDA? Or you’re done with the FDA?

 

Doesn’t make any sense to me at all.

 

As I think about this again, I really don't care. I’m not going to be filing any reports or calling the FDA anytime soon if ever as it seems nothing and I mean nothing is ever accomplished!!!!

 

Doesn't fill out report, wonders why things aren't accomplished. Do you see the problem there?

I think a possible reason for not filing is being in denial about being injured by a doctor's advice. These are painful realities.

 

I haven’t filed a report to the FDA for quite awhile now. And I’m not in denial about being injured by a doctor at all. I am injured. I’ve been switched between different generics of clonazepam 6 times in the last 3 years.

 

This has affected my CNS tremendously and upsets me greatly. I feel that contacting the FDA about the dangers of benzos is a waste of my breath if the FDA will never acknowledge that there is great variability between generics of any benzo and great variability between people also.

 

If we are to constantly be “urged” to contact the FDA about these dangers, why are we not emphasizing these other important factors also?  I also strongly believe that the slow tapering as suits the person should be emphasized also.

 

So 4 things in my opinion  all of equal importance>>>>

 

Benzo dangers, Generic variability, Individual variability, Slow tapering as per the person involved.

 

If we are to inform people, doctors, and the FDA, lets really do the job full throttle.

 

I contacted the FDA by phone almost a year ago, and I was switched around to various departments until I was finally given to a pharmacist. She seemed completely uniformed about anything regarding benzos, was unable to navigate the FDA website, and when I asked about all the generic discontinuations, she said to me, “What discontinuation are you talking about? I see no discontinuations whatsoever.”

 

Please remember that we are dealing with bureaucracy here before anything else who just want a problem solved as fast as possible. So in my opinion once again, if we advocate for anything, do the whole “job” as one may  find themselves “pulled off” a benzo before they are even close to being safely off of it.

 

These are painful realities for me.

 

 

Just had to add that I’m fed up with these experts also as in Anna Lembke MD. She uses plenty of addiction language when speaking of benzos, and says quite frequently that these drugs should only be used for 2-4 weeks. I tend to think that we know that time frame by now and pretty much else she says also.

 

As far as addiction period, I do not crave this drug one iota. In fact, I dread even taking it. Just the thought of that repulses me.

 

Yes, I “see the problem there.”

 

But I’ve filled out reports and made calls as I’ve written. How many times do you believe I should continue to do this? I’m one person and not thousands.

 

The FDA gets numerous reports and calls each day and not just about benzos but other medications also.

 

It is a sense of futility for me. 

 

I have LOOKED INTO filing a report -

 

But on a different (very dangerous, and I suspect moreso if Px to a person using benzo "as prescirbed")

 

The drug (Chantix) was test for (COUGH) "Safety & Efficacy" on users of several other Psych Meds, I've turn ncbi upside down and can find not even a "CASE REPORT" - good or negative - regarding Chantix w/ a benzo Px person.

 

My therpapist (Phd, 25+years) genuinely suspects more brain damage than I had before, and "This isn't what I typically see with B alone".

 

Would it not be most effective if the PROFESSIONAL submitted the "Adverse Event"?

 

I'm wagering the reason most people do not file is - the sense of futility. AND ABSENT CONEXT. - - how can ya make even a rough estimate without "Events per ?"

 

e.g. we easily see 1013 AE's (hypothetically) but were 10,130 Px written? 101,300 Px? Or Millions of Px? nowhere can I find the number of Px (w. respect to any drug) for the year - Can't find the "Number of Px" @ even the pharma companies sites, the pdf's of their "Prospectus" NO PLACE. Research is what I DO - recovering hacker - The information HAS to exist, if "meh" can't find it, that means it's WELL HIDDEN (intentionally)

 

FAERS (fears?) is better than nothing, but itself bears "looking into". With all the rigorous "Prescription Monitoring" we now have, there's NO EXCUSE for the missing data

 

What GENUINELY takes place when the report is filed? I turned the "FAERS" site inside out (and searched every else-where) but could find ZILCH about "action following report"... it seems these are merely recorded and stored - - they CAN be looked up, very specific even (I searched FAERS for the drug-combo as well) but not even a HINT of what happens next - I suspect the MISSING information @ FAERS is omitted intentionally.

 

If anyone knows how the FAERS "takes action" on these reports I'm ALL EARS - if the ACTION FOLLOWING such reports were transparent I'd wager MANY more people would submit (I aim to ask Therpaist to do so anyways_)

 

MUCH THANKS

LC

 

 

 

Yes, I “see the problem there.”

 

But I’ve filled out reports and made calls as I’ve written. How many times do you believe I should continue to do this? I’m one person and not thousands.

 

The FDA gets numerous reports and calls each day and not just about benzos but other medications also.

 

It is a sense of futility for me. 

 

 

You only need to fill out one report per person. Eventually the data will be taken and used to help us. Not reported, didn't happen. It's a slow burn but things are being done. The medical ignorance about benzodiazepines is beyond belief. Half the issue is healed people never come back or report the harm as well. Just sick of it and move on. Gives us small numbers of totally disabled people to work with at one time. You can see current report stats here: https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard

 

Yes, I “see the problem there.”

 

But I’ve filled out reports and made calls as I’ve written. How many times do you believe I should continue to do this? I’m one person and not thousands.

 

The FDA gets numerous reports and calls each day and not just about benzos but other medications also.

 

It is a sense of futility for me. 

 

 

You only need to fill out one report per person. Eventually the data will be taken and used to help us. Not reported, didn't happen. It's a slow burn but things are being done. The medical ignorance about benzodiazepines is beyond belief. Half the issue is healed people never come back or report the harm as well. Just sick of it and move on. Gives us small numbers of totally disabled people to work with at one time. You can see current report stats here: https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard

 

I’ve filed numerous  reports of adverse effects with the FDA because I’ve been switched around to several versions of generic clonazepam over the years. Not one report, but several.

 

So those switches were Actavis to Sandoz to Actavis to Sandoz to Actavis to Sandoz. I don’t think I’m leaving anything out, but I seriously do not remember. I really only remember that the Sandoz gave me a sense of being strangled when I took it the first time aside from the burning and tingling feeling. And that is when I filed my first report. Then I was put back on Actavis, and by then, other  problems had started and I filed another report. Probably4-5 different reports by me.

 

I just can’t keep filing reports. That really makes no sense. With so many times being switched around, one would think I’d taken numerous other types of psychoactive substances, but I haven’t. No ADs, no APs, not even one supplement like magnesium or a vitamin pill.

 

So the FDA has all this information if they want to use it, but they don’t seem to want it or need it. I’ve never been contacted although as I say, I’ve certainly contacted them by form and by phone.

 

I’ve even reported that I’ve had idiopathic subglottic stenosis which this clonazepam has seriously impacted and has made things much worse for me.

 

Should I keep reporting? I don’t think I should and I don’t think I will.

 

 

 

Yes, I “see the problem there.”

 

But I’ve filled out reports and made calls as I’ve written. How many times do you believe I should continue to do this? I’m one person and not thousands.

 

The FDA gets numerous reports and calls each day and not just about benzos but other medications also.

 

It is a sense of futility for me. 

 

 

You only need to fill out one report per person. Eventually the data will be taken and used to help us. Not reported, didn't happen. It's a slow burn but things are being done. The medical ignorance about benzodiazepines is beyond belief. Half the issue is healed people never come back or report the harm as well. Just sick of it and move on. Gives us small numbers of totally disabled people to work with at one time. You can see current report stats here: https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard

 

I’ve filed numerous  reports of adverse effects with the FDA because I’ve been switched around to several versions of generic clonazepam over the years. Not one report, but several.

 

So those switches were Actavis to Sandoz to Actavis to Sandoz to Actavis to Sandoz. I don’t think I’m leaving anything out, but I seriously do not remember. I really only remember that the Sandoz gave me a sense of being strangled when I took it the first time aside from the burning and tingling feeling. And that is when I filed my first report. Then I was put back on Actavis, and by then, other  problems had started and I filed another report. Probably4-5 different reports by me.

 

I just can’t keep filing reports. That really makes no sense. With so many times being switched around, one would think I’d taken numerous other types of psychoactive substances, but I haven’t. No ADs, no APs, not even one supplement like magnesium or a vitamin pill.

 

So the FDA has all this information if they want to use it, but they don’t seem to want it or need it. I’ve never been contacted although as I say, I’ve certainly contacted them by form and by phone.

 

I’ve even reported that I’ve had idiopathic subglottic stenosis which this clonazepam has seriously impacted and has made things much worse for me.

 

Should I keep reporting? I don’t think I should and I don’t think I will.

 

You seem to be a super reporter! I just did it once! Good idea to report all the various generics! I don't know if you should keep doing it. It's up to you! Funny how much I misread your first statement. I apologize!

Thank you MsAtomicBomb.

 

No need to apologize. We all just do the best we can when we first learn about these benzos.

 

So far, my mind is still intact after all this “jostling around.”

 

I’m very glad about that since I have a hunch I’m going to need it. 🧡

So first off, that's only reporting symptoms. That's all it does. And then also, you can call the company yourself directly instead of filling out forms. I called Genentech a few weeks ago and reported all of my adverse symptoms caused by the benzos. You could probably do the same with up John or any of them, they have their own FDA reporting team. You tell them what you experienced and they type it for you. Problem with all of this, it doesn't do anything. For every one of us that says something, there's probably a hundred people doing well on the med. And I gave them my doctor's info as well, so they can call her. But this still doesn't do us any good, we need a class-action. The only way to do that is to get people's info but I don't know how we're supposed to do that on this website. I've had tons of lawyers recommend getting a class action started but I don't know how I'm supposed to do that on benzo Buddies. So instead of reporting stuff to the FDA, which is also great, we need a way to do a class-action or mass tort.

More on this in this video: (timestamped)

Yeah so there's a cardiologist on the benzo coalition. And there's a way to report adverse symptoms. That's not going to help us though. We need a class action lawsuit. And whether it's called addiction or physical dependence doesn't really make a difference because the company said they don't recommend us taking it longer than 4 weeks in the first place. So how are we supposed to get any money? We've got bills to pay.

Yeah so there's a cardiologist on the benzo coalition. And there's a way to report adverse symptoms. That's not going to help us though. We need a class action lawsuit. And whether it's called addiction or physical dependence doesn't really make a difference because the company said they don't recommend us taking it longer than 4 weeks in the first place. So how are we supposed to get any money? We've got bills to pay.

 

We will never get any money from these reports. It's to help change the story. Class action is really unlikely for many reasons, but I'd imagine it would be at least slightly more likely the FDA agreed with us.

Well I guess I can see how it would be beneficial to us. If we have the FDA agreeing with us, that means the medication made by the company directly affected us years after we quit taking it. And because of that, lots of us need compensation for it. Not all of us, but some of us. At least it would be a step in the right direction. As far as the company's having lots of money and being big and bad and scary and whatever else lots of people assume, that's not really a problem. The reason I say it's not a problem, it's because the company didn't purposely injure us. They actually made medications to help us. So if they are aware that they have injured us and caused us financial hardship, most likely they would help us out. That's just my opinion at least.

Well I guess I can see how it would be beneficial to us. If we have the FDA agreeing with us, that means the medication made by the company directly affected us years after we quit taking it. And because of that, lots of us need compensation for it. Not all of us, but some of us. At least it would be a step in the right direction. As far as the company's having lots of money and being big and bad and scary and whatever else lots of people assume, that's not really a problem. The reason I say it's not a problem, it's because the company didn't purposely injure us. They actually made medications to help us. So if they are aware that they have injured us and caused us financial hardship, most likely they would help us out. That's just my opinion at least.

 

They wouldn't help us out and they are very aware. Every benzo original company is now owned by Pfizer. The largest class action ever was in the UK against Valium. They didn't help, they bled it until the action ran out of money. Xanax original owner was Upjohn and they knew in the clinical trials that everyone got worse after week 4 in a 43 week trial, so in response they only reported results until week 4.

 

https://www.benzoinfo.com/2017/01/07/upjohn-study-shows-xanax-alprazolam-impairs-recovery-from-panic-disorder-and-agoraphobia/

You are giving out incorrect info. First off, Genentech makes diazepam and clonazepam. I have been in contact with them over the last few months, they are located in San Francisco California, and their headquarters are in Switzerland. They have 55000 employees and the company is worth 200 billion dollars. But that doesn't mean anything. The problem we are running into, is because they don't recommend taking them any longer than four weeks. That is also the same reason up John did not publish anything further than that. Why would they publish anything further than 4 weeks if they don't recommend it? They're not purposely hiding things. It's not like there's some big evil company out to kill people. It's just like that company that makes the medicine that got jacked up dramatically, the guy with the black hair. I can't remember his name, but the public was giving him all kinds of crap saying he was this big evil person that just wanted to Jack prices up for no reason, well if you dig a Little Deeper he has lots of interviews and there's a big reason for him doing what he did. And also he's giving out free medications to whoever wants them and qualifies. So everything is deeper than what you see. You can't just say oh, this company purposely ruined us and they're not going to do anything about it because they don't care about us. How would you know that? And I hear you on the case, but I don't think they purposely Let it bleed out. My guess is that the defense of the case didn't get what they needed in time. Maybe there was some kind of technical difficulty or maybe one of the jurors got sick or the judge had to take a break for something. Who knows right? For example, if I started making a medication today and it injured lots of people, I would help those people. Especially if I had two hundred billion dollars like Genentech. I'm sure there would be all kinds of poor people and other people making assumptions about me if I had 200 billion dollars, saying that I don't care about people and that I have better lawyers than everybody else. When the reality is all lawyers are the same, they do the same job, some do it better than others. There's equal protection in place for every company set by the government. The government has a purpose. Just because a company has money, doesn't mean they can get around that purpose. And why would they want to in the first place? Anyways, I feel like everybody is scared to sue a company when it's really not that difficult. I think the only difficulty is because the company says they don't recommend taking it longer than 4 weeks. There's really no other reasoning we wouldn't get money. Maybe if we had been injured for taking it less than 4 weeks and it was directly due to the medication, it would be very simple. But most people took it way longer than that. Anyways, I'm going to continue to pursue it and I don't care about other people's opinions or what they think on how difficult it is or how bad the company is or whatever else.

You are giving out incorrect info. First off, Genentech makes diazepam and clonazepam. I have been in contact with them over the last few months, they are located in San Francisco California, and their headquarters are in Switzerland. They have 55000 employees and the company is worth 200 billion dollars. But that doesn't mean anything. The problem we are running into, is because they don't recommend taking them any longer than four weeks. That is also the same reason up John did not publish anything further than that. Why would they publish anything further than 4 weeks if they don't recommend it? They're not purposely hiding things. It's not like there's some big evil company out to kill people. It's just like that company that makes the medicine that got jacked up dramatically, the guy with the black hair. I can't remember his name, but the public was giving him all kinds of crap saying he was this big evil person that just wanted to Jack prices up for no reason, well if you dig a Little Deeper he has lots of interviews and there's a big reason for him doing what he did. And also he's giving out free medications to whoever wants them and qualifies. So everything is deeper than what you see. You can't just say oh, this company purposely ruined us and they're not going to do anything about it because they don't care about us. How would you know that? And I hear you on the case, but I don't think they purposely Let it bleed out. My guess is that the defense of the case didn't get what they needed in time. Maybe there was some kind of technical difficulty or maybe one of the jurors got sick or the judge had to take a break for something. Who knows right? For example, if I started making a medication today and it injured lots of people, I would help those people. Especially if I had two hundred billion dollars like Genentech. I'm sure there would be all kinds of poor people and other people making assumptions about me if I had 200 billion dollars, saying that I don't care about people and that I have better lawyers than everybody else. When the reality is all lawyers are the same, they do the same job, some do it better than others. There's equal protection in place for every company set by the government. The government has a purpose. Just because a company has money, doesn't mean they can get around that purpose. And why would they want to in the first place? Anyways, I feel like everybody is scared to sue a company when it's really not that difficult. I think the only difficulty is because the company says they don't recommend taking it longer than 4 weeks. There's really no other reasoning we wouldn't get money. Maybe if we had been injured for taking it less than 4 weeks and it was directly due to the medication, it would be very simple. But most people took it way longer than that. Anyways, I'm going to continue to pursue it and I don't care about other people's opinions or what they think on how difficult it is or how bad the company is or whatever else.

 

Those are generic manufacturers. Who owns the patent is who is responsible legally, not the manufacturer. You are free to pursue whatever you want. I went to law school and spent 2 years researching this, even started a group dedicated to it, so perhaps I could save you some time. However, I wish you well on your adventure.

Sorry, didn't mean to be negative. I've also researched this for a long time, almost 20 years. And that's great you went to law school, are you allowed to practice law? If so, let's get this started. The amount of time everybody spends on benzo buddies, we could be getting money. And I don't necessarily think it's the person that holds the patent, I'm sure the generic is equally accountable. They still make a product. For example, if you buy a generic cereal from the grocery store, and it makes you sick, you don't Sue General Mills. Or let's say you buy some vitamins at Walmart, you would sue equate, not once a day. So I'm pretty sure we could sue Genentech and not the other companies, but we would have to have an actual lawyer to do so. I've got my doctors and pharmacists backing me up on everything, which is great. Now I just need somebody willing to take the time out of their day in order to start a suit. I could do that myself, but I'm pretty sure it cost money. I don't have money.

Sorry, didn't mean to be negative. I've also researched this for a long time, almost 20 years. And that's great you went to law school, are you allowed to practice law? If so, let's get this started. The amount of time everybody spends on benzo buddies, we could be getting money. And I don't necessarily think it's the person that holds the patent, I'm sure the generic is equally accountable. They still make a product. For example, if you buy a generic cereal from the grocery store, and it makes you sick, you don't Sue General Mills. Or let's say you buy some vitamins at Walmart, you would sue equate, not once a day. So I'm pretty sure we could sue Genentech and not the other companies, but we would have to have an actual lawyer to do so. I've got my doctors and pharmacists backing me up on everything, which is great. Now I just need somebody willing to take the time out of their day in order to start a suit. I could do that myself, but I'm pretty sure it cost money. I don't have money.

 

The supreme court did a case on this and as manufacturer cannot change the RX literature they cannot be held accountable. Even more complicated, they left it up to the states to decide who is responsible. Some decided patent holder, some decided nobody. Nobody is going to take this case. I found one who would if there was 80k people he'd find a way through fraud.

Interesting. I spoke with a lawyer last week from San Francisco, because that's where Genentech is. He told me in the state of California, they made it where you cannot Sue a company like them due to politics. He said you would be much better off finding an attorney in your state, also due to the fact that here in North Carolina, is where my doctor is. He said it might be the doctor's fault, and it might be Genentech fault, or it might be both. So I contacted an attorney last week here and she was interested even though it's a big company, and she started to work on it, but then said it would be too hard because of mental health conditions. I have diagnosed mental health conditions so I guess people have a hard time believing anybody with a mental condition. So she just made it worse. And I've contacted lots of other ones here, but half of them say they don't have enough money which pretty much means they're not going to waste time. I've been told to contact ones in Charlotte and Raleigh because those are bigger cities but I haven't gotten around to it yet. Maybe I will let this whole so-called epidemic build up a little bit, since it's already gaining some traction, and once there's enough doctors that know about it, I will reach out to the big cities. And I'm not looking to get millions of dollars, although that would be cool, I'm just trying to get enough money to reimburse everything that went wrong and pay off my medical bills so I can get my credit back to normal. I'm actually a really humble person and I don't need much.

Interesting. I spoke with a lawyer last week from San Francisco, because that's where Genentech is. He told me in the state of California, they made it where you cannot Sue a company like them due to politics. He said you would be much better off finding an attorney in your state, also due to the fact that here in North Carolina, is where my doctor is. He said it might be the doctor's fault, and it might be Genentech fault, or it might be both. So I contacted an attorney last week here and she was interested even though it's a big company, and she started to work on it, but then said it would be too hard because of mental health conditions. I have diagnosed mental health conditions so I guess people have a hard time believing anybody with a mental condition. So she just made it worse. And I've contacted lots of other ones here, but half of them say they don't have enough money which pretty much means they're not going to waste time. I've been told to contact ones in Charlotte and Raleigh because those are bigger cities but I haven't gotten around to it yet. Maybe I will let this whole so-called epidemic build up a little bit, since it's already gaining some traction, and once there's enough doctors that know about it, I will reach out to the big cities. And I'm not looking to get millions of dollars, although that would be cool, I'm just trying to get enough money to reimburse everything that went wrong and pay off my medical bills so I can get my credit back to normal. I'm actually a really humble person and I don't need much.

 

If you have a case against your doctor do not wait. The statute of limitations runs out fast. I only know one lawyer in the country who can handle these types of cases against doctors appropriately. He's listed in resources on our site, but he's not in a rush to get new cases.

I don't really think I do have a case against my doctor, that's just what that San Francisco lawyer told me. He said she was over prescribing and prescribing for too long. I'm guessing it would be next to Impossible to get money out of that because the doctor would say they thought it was medically necessary and that's why they prescribed it. It's too hard to tell the doctor that they're wrong. As for the pharmaceutical company, they have injured all of us. There's nothing they can say that makes that any different. So I'll just hold off at this point until there's more people on board.

Done