Law suit against dopamine agonists?

[Belsheart]

Tonight i find myself wondering if it would be possible to dosome thing like a class action law suit against manufacturers ofrequip and miripex. The withdrawal process is so difficult

[Madlegs1]

And alcohol,sweets,chocolate,fast cars, loose women, sugar,shopping for handbags or shoes, smoking,money machines (ATMS)

Oh-- I give up!

Let's have a vote for personal responsibility-- we all have choices and can research. (as never before,what with the internet and Google search facility)

Every medication comes with extensive patient information leaflet.

Now-- if something does NOT do what it says on the tin ,then we should complain. Viz- oxycontin not lasting the full 12 hours.

I'm with you for that one.

Cheers- and keep posting🤩

[Belsheart in reply to Madlegs1]

I have to respectfully disagree. Just as cigarette manufacturers hid issues with cancer, i suspect dopamine agonist withdrawal and augmentation has been known to companies farlonger than the public was told. Additionally, many of us have complex medical issues and it is very hard to sort it all out, even with Google, self responsibility and a reasonably good brain

[Hidden]

There have been law suits against the the manufacturers of Requip and i think Mirapex in the past because of people having compulsive behaviour they never had before, people lost their houses, jobs family etc, I dont know about the withdrawals, do you mean you have been augmenting on one of those meds. ? Having Augmentation has been a BIG problem with people taking the dopamine meds. We see it everyday in all the RLS groups., including on this forum. BUT, lots of meds can give withdrawals when you have to wean off them. So it would really be a law suit from having Augmentation from taking them and then the awful withdrawals getting off of them so i guess a double whammy.

[Hidden in reply to Hidden]

Very interesting indeed all this about augmentation. As fas as I understand it, and it's the same with many medicines, it took a longish time before augmentation became apparent or that it was recognised for what it was rather than the effect just wearing off, and it took even longer to see what withdrawal was like for those who had augmented. I think the time scale for the initial studies is not long enough to allow some of the worst effects to become apparent.

If there was anything in the initial research which showed that augmentation was known about and then hidden that would be something very important though.

Once it's known about at that point I think there should definitely be a widespread alert, though what augmentation feels like as opposed to the word itself is hard to recognise.

I knew as GP that when prescribed for Parkinsons there were side effect issues I did not fancy at all made me instinctively not want to consider trying so i expect others may have had suspicions as well.

I distinctly remember before these DA's came out there was a huge publicity campaign about RLS and the number of sufferers with no idea why only I was intrigued as i already had it. There is no doubt in my mind that this campaign was led by the drug companies as lo and behold out came the drugs once the market had emerged. That did make my highly suspicious.

Everyone who has augmented in the UK ( i don't know about the US ) should definitely do a yellow card alert. It is recognised that once a side effect is known about folk tend to stop reporting it so the extent is not seen. It also helps to see if important patters emerge as they ask all sorts of questions like timing and other drugs.

In my opinion it is also serious enough for a widespread alert to be sent out. It may be culpable that there hasn't been?

If they don't send alerts then Jo Bloggs Drs who have to keep up with every available medicine are unlikely to have the time to read all date sheets regularly. They tend to rely on alerts to let them know of important new info.

[Hidden in reply to Hidden]

Apparently augmentation was known by the manufacturers and hidden. And i agree with you 3 months of double blinded studies are not long enough to see what further down the line might appear.

[Hidden in reply to Hidden]

Well that's very interesting! I didn't know that. In fact I didn't know about augmentation until I came on this site. I retired 8 years ago and I don't think it was known about then. I never prescribed it and would have hesitated as above for myself and others. The longer in the tooth I became as a Dr the more I became wary of all sorts of medicines ..... though I did believe the hype about pregabalin for some reason and got myself into an augmented situation with that somehow!

If folk had the stomach for it I do wonder if some legal action might be possible if the evidence was hidden. But then what use is money if folk still have RLS? For those who lost jobs etc as a result that may be different. I definitely think there should be a big alert and ongoing central reporting as above. It is still not a 'mainstream' condition or one which attracts public sympathy so there is far more advice, finance and info out there for eg cancer,heart disease etc

[Hidden in reply to Hidden]

Lots of people still to this day dont know about augmentation til they cant stand it any longer and find a RLS group to get help and thats when they find its augmentation they have. I wouldnt tell anyone to NOT take any of them, as long as they keep to the now new recommended doses and that is info they NEED to know. They could get years of good relief from taking a DA once informed.

[Hidden in reply to Hidden]

That seems very wise advice. I am just scared of anything that can make things worse - it's bad enough as it is! Is it certain now that as long as the low doses are kept to that augmentation doesn't occur? And once the start of the effect wearing off occurs is it easy enough to get off these low doses?

I only reached 150mg Pregabalin and I found it really hard to come off due to extreme restlessness even done gradually. I disliked the side effects which is why I stopped it rather than increase further and I didn't realise some of the side effects I was feeling until I was off it and they went away. I had no idea about augmentation at that time though I knew I had started at only 50mg which was effective for some time, then 100mg then 150mg. Part of me is grateful I had these better years, especially when I was still at work, and part of me wonders whether I am as badly affected now due to some long term effect of Pregabalin which is of course unanswerable!

[Hidden in reply to Hidden]

Augmentation can occur even on low doses. Its alot easier to wean off a low dose than a high dose. I am sure that applies to alot of meds, I know from what people have said that weaning off Tramadol is not easy depending on the dosage. No one knows for sure what long term taking of the meds we take for RLS is. I do know that taking nothing would be worse, seen too many people want to end their lives because they cant stand the sleep deprivation the constant having to move, having to get up and pace which will and does eventually have a affect on your body and your mental health.

[Hidden in reply to Hidden]

Don't I know it re the sleep deprivation. I have dreadful RLS. On many nights I am beside myself trying to reach the morning, pacing about, in and out of the bath. I often get a few hours sleep day time which helps. I have not had a single night free of RLS for several years. having only 2 attacks per night is a blissful night. it disrupts my life completely. i can't go on holiday or visit folk and no longer share a room with my husband.

but i have a suspicion that taking Pregabalin for several years has somehow made my RLS worse and i'm terrified to take anything else that could make it even worse.. my mother had quite severe RLS but i don't think it was as bad as mine is. i am kind of grateful for the better few years i had taking pregabalin but in retrospect maybe not if it has resulted in what i have now.

what on earth did folk do before these treatments emerged recently?

i do take 1 dose of 30mg codeine per night most nights but i wish i didn't have to.

i just have a suspicion that we are making ourselves worse in the long run by taking treatment - time will tell.

[Hidden in reply to Hidden]

You do know that RLS is progressive. It might just be after you came off the pregab that you now notice that your RLS is worse. Years ago people took opiates probably illegally. RLS has been around for centuries.

[Hidden in reply to Hidden]

Yes, I do know it's progressive. But it was as bad as this before I came off the Pregabalin. The dose I was on was no longer helping it and i didn't feel i could increase it any further due to side effects. It felt just like augmentation is now described with it coming on earlier in the day and more severely and with other areas of my body affected and this persists even now. It also made my blood sugar drop suddenly - a recognised side effect in Diabetics but it happened to me as well and I know I'm not diabetic, and it made my balance awful. I took it for an unrelated reason and found by chance it helped my RLS so begged my GP to keep giving me it. This was way before it was generally known to help RLS and i called the drug company to inform them I was convinced it did. They did suspect but were just doing trials they told me. The renal physicians knew about it for their dialysis patients and were using tiny doses off licence I then learnt.

I still think there's an awful lot we don't understand about RLS, like the evolution in

understanding of lots of conditions. At first re DA's no one seemed to twig that the augmentation was this and also blamed progression of the condition.

My gut feeling is that the Pregabalin caused a permanent worsening.

Most folk could not get hold of opiates in the past. I know RLS has been around for years but there didn't seem to be the same numbers of severe cases known about. Only once in my entire career did anyone approach me about it and I recognised it as I had it myself. There was no recognised treatment at that time so I sympathised but couldn't help. I knew my Mum had it and it seemed rare.

The DA's for PD used to be prescribed early and readily till eventually it became apparent that there was a window of time during which they helped and then they became ineffective so eventually it was thought best to prescribe late rather than early.

.... anyway, I obviously don't know for certain but the above is my gut feeling

[Belsheart in reply to Hidden]

I'm with you. I feel the DAs made mine worse

[LBBlack in reply to Hidden]

I am still new to this site and I value the experience of each of my fellow sufferers, regardless of their background. The experience of medical professionals like yourself, Allison, who have worked with a variety of RLS sufferers is a special gift. Many of us do not have easy access to medical people who understand RLS and the rapidly changing dosages recommended by new research. It can take courage to pass on the best we learn here to our overworked doctors, nurses, and caregivers. Any suggestions? Thank you for your gift to us.

[Hidden in reply to LBBlack]

It's kind of you to say so but honestly I am no special gift to you as I know no more about RLS medically than others on this site and in fact often less - but I'm learning from others. I never treated anyone with RLS when I was working. the treatments were just appearing late on in my career. i have no idea what folk did before these emerged. i know my mother had no treatment. what I have learnt is from personal experience of having RLS myself and some of the history of the treatments emerging.

[Belsheart in reply to Hidden]

Great point. Vulnerable patients, such as myself, have a constellation of issues that make withdrawal even more arduous because we can't use bridge meds

[Joolsg]

I agree. However, all dopamine agonists have a detailed section in the information leaflet about Augmentation. The problem is GPs not bothering/ having time to read the leaflets. They then increase the dose so the Augmentation becomes worse and the withdrawal hell.

Legally, they could rely on the warning about Augmentation in the leaflet.

I actually have been in correspondence with Glaxo Smith Kline - manufacturer of Ropinirole in UK about this matter and they shut me down straight away- passing the blame to the doctors.

I do feel it’s an education matter. Most GPs and neurologists are totally ignorant about RLS, Augmentation and withdrawal. The drug companies are reluctant to send out a general “warning” letter to GP surgeries and neurologists about the increasing cases of Augmentation.

If you’re in the UK, file a report in the Yellow Card scheme. If in the US , file a report with the FDA.

I’ve done both. The more of us who report Augmentation as a severe side effect, the more chance we have of doctors realising there is a problem.

Take care

[Hidden in reply to Joolsg]

Thanks Jools i didnt know that Augmentation had been added to the list of side effects in the leaflet. So, i have learnt something new today. So, legally a law suit would be hard to bring about. But its also up to the person who is taking the med to read the leaflet, i ALWAYS read the leaflet of any new med i take, so i can beware of what side effects i MIGHT get, as not all side effects effect everyone, but the HAVE to list them all. BUT yes, doctors and neuro's SHOULD know about augmentation by now AND how to deal with it, so when a patient tells their doctor i am having augmentation the doctor wont shrug it off because they have no clue.

[Joolsg in reply to Hidden]

Absolutely Elisse.

[Pippins2 in reply to Joolsg]

Correct me of I am wrongbut I think I remember that there was a time when the manufacturers /doctors were aware of augmentation but failed to inform patients eg it wasn't in the patient information leaflet, then it was added? X

[Joolsg in reply to Pippins2]

Very interesting Pipps. I wonder if anyone has an old leaflet. That would be very useful.

[Hidden in reply to Pippins2]

Someone we know will probably know for sure. x

[LotteM in reply to Pippins2]

The Dutch leaflet (Ropinirol by Glenmark of 03/2025) lists quite a bit of info on potential side effects such as gambling etc. But re augmentation: they don’t use the word. They simply write “to talk to your prescribing doctor when your symptoms increase, i.e. become stronger or start earlier in the day or start occurring in other limbs”. Oh, and the dose for RLS van be increased to 4mg a day!

Maybe not lack of info, but certainly limited info re augmentation and outdated info re the maximum recommended dose. Helpful?

[Hidden in reply to LotteM]

So thats an up to date leaflet..? But, not actually using the word Augmentation, i wonder why. hmmm. The problem with the out of date dosage is, only the RLS experts who KNOW and worked out that doses should now be lower , so until its "officially" changed, then no one but a few will understand the doses need to be lower. Doctors etc will still just look in their book and see the old dosage.

[LotteM in reply to Hidden]

Yes, it should be. More or less. This one is from my ‘old’ ropinirole prescription and the last time I filled it, probably wel over a year ago. And, the Dutch situation and leaflet may be slightly different from the UK one.

Re the dosages: indeed. I can see why it takes a while. And luckily here is NL md’s are not too difficult about opiates and prescribing for non-indicated (off-label?) diseases.

[Hidden in reply to LotteM]

I take a tiny bit of Pramipexole, so have a leaflet with it, but not looked at it for ages as i know how to dose myself and have enough experience of taking it. BUT, i looked earlier just to see what it said, but my leaflet is only for PD's so only gives the info etc for people taking it for PD. It does say, the med is used for other conditions. Also i am not sure when or if, the new recommended dosages for the DA's will ever change officially. I can get my tramadol and the tramacet without any problems where in live in the UK, altho i do know some doctors here are reluctant to prescribe them, but is think thats mostly because doctors have no idea that opiates work for RLS.

[Hidden in reply to Pippins2]

The doctor who prescribed Pramipexole to me never told me about Augmentation; I found it out the hard way. I don’t remember if I read the pamphlet (so I can’t tell you if it was in there or not). This was in 2012.

[Belsheart in reply to Joolsg]

So glad you reported it. I do not recall anything in the leaflet way back when i traded in my tiny bit of klonapin for my first DA.

[TEAH35]

Yes there are already lawsuits happening all over the world. I have been advised by my Australian lawyer that I should join a class action suit. But I would find it a bit hypocritical as I still use and desperately need the medication

[Hidden in reply to TEAH35]

Maybe yes and maybe no (as to hypocritical). Maybe someone like you who is on the DA is exactly who they’re looking for to make their case stronger. They get enough people on a DA, show up in court, and say “look, you people made a drug that becomes a lifesaver for people — a drug that at the same time carries this nasty side effect that people have no choice but to experience/start experiencing because they don’t want to give up their lifesaver against this very awful disease”. Does that make sense?

[Belsheart in reply to Hidden]

It does. And as a therapist, I'm well aware of the risks of sleep deprivation and corresponding isolation. Many people think this is a made up disorderto begin with.

offto another bath