I stopped Depakote – See Going on Depakote.
First Try
This was a nightmare to cold turkey off. I felt crazy, like my brain was going to explode and was on fire. I kept an ice pack on my head for days and listened to meditation tapes. I am not sure how I managed to survive let alone work. The psychiatrist of course thought I needed to absolutely be on a mood stabilizer. I told him NO to antipsychotics and Lamictal because I was terrified of Steven’s Johnsons syndrome especially with Depakote in my system and I didn’t want to sign up for akathisia or TD.
I said I’d try Trileptal which he said was similar to Carbamazepine with less side effects. So I figured I was on that before without terrible problems before the Depakote and I gave it a whirl. After all I’d go mad without a drug – right?
The Trileptal he started at a usual starting dose then brought it up rather quickly. I can’t remember the exact dose. Within two weeks, I was having swallowing difficulty, dysphagia and developed drug induced SIADH (I diagnosed myself again because by this time I was reading FDA package inserts in entirety) which landed me in the ER 2 times and then the ICU with a Na of 123, severe HA and paresthesias. I had a GI workup. All of these side effects were med induced. Time to change psychiatrist
Back on Depakote
My new psychiatrist, at least appreciated my circumstances and recent SE with these meds. The dysphagia was awful and lasted for months. My brain was in shock. I’ll admit I did feel a bit nuts at this time. Who wouldn’t? My new doctor stopped the Trileptal and tried Lithium for about two weeks which didn’t work again it just made me nauseated (not surprising).
We decided to go back on the Depakote after a washout period at a lower dose. We check LFTs, Na, ammonia levels and everything seemed ok but I kept not feeling great although nowhere as bad as I had been. My brain chilled back out.
Flash forward one year, my foot healed, I was racing my mountain bike and hit a root and landed on my right shoulder and fractured it in three places but the bones stayed in place, so a bad fracture but I didn’t need surgery. I forewent the Advil having my prior experience and toughed it out with a sling, grit and ice packs worked with a broken shoulder (only took two shifts off) and now I am back a year and a half later racing my bike and trail running again. I mention this because both of my fractures, I’m not certain would have been as bad without me being on the Depakote. I think it may have weakened my bones, but I am too afraid to get a Dexa Scan.
I also mention this because a CT scan was done at the time of my shoulder fracture and this showed a 6 mm nodule in my lung. I went to a pulmonolgist and they did a more precise scan and determined this to be most consistent with intraparenchymal lymph node. Also of note, is a note in the FDA package insert that rats “a dose related trend for benign pumonary adenomas”. This was particularly weird and frightening.
Tapering This Time
With my current psychiatrist’s support over the period of the last year and a half I have successfully tapered the Depakote. I made this decision because I physically cannot tolerate it any longer. It is making me sick. It’s almost as if my body is rejecting it. While tapering however I began having new symptoms and some of these have resolved, some have not. I have a fullness in my throat at times, restless legs more pervasive since tapering, parasthesias in my feet and asthenia. I also get this cold dysthesia, mostly on the right side of my face and have had some pupil autonomic dysregulation specifically to light upon waking – they don’t accommodate right away.
The newest is my Hga1C was 5.9 a month ago. I’m 5’5″ an athlete and 128 pounds. Not your typical picture of someone with impending diabetes. So I’ll get it rechecked in a bit when my system levels out.
Four months ago I was on 500 mg Depakote daily. I still was having ill effects from the drug – usual Depakote SEs so I weaned down to 250mg. I weaned to the 500 from 1000 over the course of six months. That was the easy taper. It was after 500mg the withdrawal symptoms started.
Oh boy! Crazy stuff. At the time when I did this in May I was running a 25k trail race called the Dirty German and after the race I felt like I just couldn’t recover like normal. I had severe muscle fatigue and lack of power in my legs no matter what I did. Taking time off did not help me recover to my surprise. Then the dysthesia started. Cold on the right side of my face tingling in my scalp burning sensations. Visual disturbance specifically with my pupils and lack of ability to accommodate to light. I had this happen a few times at work in the fluorescent lighting and upon waking up from a nap in bright sunlight. After it happened a few times, I checked my eyes in the mirror and sure enough either one or both pupils were huge and not reacting as they should. It is transient and resolves within about 4 mins but when it first happened I thought I was having a stroke.
These were the major symptoms. They come and go throughout most days. I thought I had MS or some other weird neurological thing going on. So I went to my primary who listened but was unhelpful, then went to a neurologist who confirmed I didn’t have any crazy neurological disease and asked if I really needed the Depakote. He said since you are only taking 125 mg, why don’t you just stop?
I tapered to half for a week and stopped. Things were relatively ok but the symptoms I got before intensified and then I had increased anxiety after about 7-10 days off completely. This was not normal anxiety. It was purely physiologic like my body just was in overload as a result of withdrawal to normal stressors. I knew That it was withdrawal and so was able to focus on my work and continued taking care of my patients. The worst withdrawal effect however is the buzzing in my brain. It’s worse at night when I’m not distracted and comes and goes. The best way I can described it is like a tinnitus but like a buzzing in the brain. It creates sleeplessness.
I’ve been pretty lucky and have had only minor distractions in my sleep but two nights ago had this buzzing and anxiety and could not sleep. I got about two 1/2 hours maybe. I felt like crap the next day. I was signed up for this year’s first Cyclocross race the day after this and was so excited to race and then this happened. I was so angry that I said the hell with it, I’ll race on no sleep. I did and although I could have raced better without going through drug withdrawal and some more sleep, I raced well and the exercise helps my brain level out soooo much.
That night I broke down and took a smidge of Depakote – emptied the 125 capsule to about less than a quarter and took it to try and quiet my head. I definitely had less withdrawal symptoms the following day. Interestingly coffee interacts with Depakote and intensifies my withdrawal symptoms. I never knew why I always felt so different after drinking coffee and pretty darned awful all these years. It’s the Depakote. I’m certain. And I have the documented scientific data to support my experience.
This is where I am now. Back to the drawing board with a slower taper. Unfortunately my doctors – pcp psychiatrist are not really much help. Not unexpected. I was happy to see the ISMP in their 2017 report noting these withdrawal effects are real for many of these drugs. That’s a start.
Overall these symptoms are improving and getting fewer and far in between but I am not sure what permanent damage has been done and what may resolve with time. The asthenia is improved and my exercise tolerance is amazingly better. With each dose drop, emotions, feeling experience is more crisp, less blunted and life affirming. I had to talk myself through each dose drop and realize it’s just withdrawal of the drug and I am not going to go crazy or get manic. I had to remind myself, that I never was actually manic.
Perspective
I’m saddened by my experience because of the years of suffering I have had to endure when I feel like if I was told long ago a drug free life without going mad was possible, I may have attempted it long ago with support. Also of note, I have no more Raynaud’s, temperature regulation normal now, as is thyroid function, no more butterfly rash, or hair loss. The nausea is gone and my stool is a normal color and urine has never been more yellow. How many other people are out there like me? This is the thought that scares me. To me the key to figuring out mental illness whatever that exactly means, requires looking at a person in entirety which is seldom done these days at least from my personal and professional experience.
Things I’ve found helpful are eating healthy, avoiding or at least consuming minimal amount of other things like coffee herbs whatever that can also affect your brain function. Alcohol is a no no for obvious reasons. My work keeps me very focused and I thoroughly enjoy taking care of patients and practicing pharmacovigilently. It’s quite interesting to see the response of different docs pharmacists patient etc when I get preaching about ADRs SEs less is more etc. I’m careful to cite research always and back it up with pharmacy support. Sometimes it’s positive, sometimes mostly by the psych people interestingly not acknowledged. I see ADRs mostly from drug to drug interactions more rarely as strict ADRs. Every day I see the effects – good and bad of medicines and I feel like I do add value in an effort to change the mainstream mindset of prescribing to one that is more discriminating and critical. Mostly I feel medicines do more harm than good.
The process I believe is akin to healing a broken bone. Stress and remodeling. The system is plastic I think in most cases – it’s just determining how slow to peel things back. It’s an individual process but there are commonalities. I’m almost inclined to think stressing the system and then pulling it back (giving smidge more drug) actually may help.
While my broken foot was healing nearly three years ago, I started to notice a pattern. Each night like clock work at around 7-8 0’clock my foot would get hot, swollen and I would get worse pain. I found a press release by Penn Medicine a few years back talking about research in healing which found that a certain gene expression of messenger RNA (Mtor?) was tied to circadian clock and would turn on/off healing. That was exactly the process I was experiencing. My point is the cycle and the idea of a bone healing as a model for neurotransmitter healing. Stress in bits and pieces are good but the right support needs to occur to if you will and time is key.
Overall, reduced stress, exercise, sleep, dense nutrition with important micronutrients (things like nuts- almonds, walnuts for magnesium selenium etc) greens, liver etc. I’d go so far as to say sleep is monumentally important and if severely disturbed in someone, needs to be supported in some way, even pharmacologically. Exercise also essential. We can’t pharmacologically create what both sleep and exercise do. There’s got to be bench research out there about neuroplasticity specifically in TBI injury cord injury that can be applicable to neurotransmitter brain trauma and healing.
Lastly but so important is the underlying stability of the person being healed. We in most cases are fragile people who have experienced trauma in many ways and psychological preparedness for the stress of this needs to be established before trying to taper. It’s monumentally hard. Internal and external resources are so important in the way of supportive family, friends, work, professionally – psychiatrist, psychologists, therapists.
The good and bad news is no drug fixes this.
annie says
Fantastic story, well done
One of my lingering effects of Seroxat, is head noise, too..
Its like an electrical fault, buzzing away, but, the worst are the ‘head explosions’, always at night.
The zaps went on for years and years, but sometimes now I get a run of small explosions in my head. Imagine a hand-grenade or a fire-work, in your head.. Pow Pow Pow
A few months ago, I had a monster explosion in my head. It was so colossal, my head lifted off the pillow. I used to have body-type seizures, cold-turkey from Seroxat. My body would lift off the bed. It was quick and sudden and gone in no-time.
But, this head thing is something else.
It is not tinnitus, which is a ringing in the ears.
This feels like it is deep under the skull.
Deep.
.
Karl says
Hi Annie can relate with what you wrote I had zaps for years to very frightening like you said seizure type episodes after seroxat. I also developed intrusive thoughts and images that I’d never had when I came off did you get anything like that. Never had ocd before
annie says
Hi Karl
It is extremely difficult to recover from the insane amount of withdrawal effects we were bombarded with from Seroxat. The absurd pil leaflet, the absurd guidelines, don’t cover it.
Trying to come out of all that, is very hard to divorce real from unreality.
It is a very gradual process.
Weird thoughts were intrusive, how could they not be..
I knew my thoughts were distorted, and the only way I could combat this, was to do my best to act and think normally.
I started a gardening business, there was no way I was going to go down the benefits and disability routes, that would have hindered me even more. I am very independent.
Doing hours and hours of weeding in the freezing cold, took the edge off, plus having to home educate my child and walk the labrador for hours – it was really hard, but, I think it helped to disentangle the distortion back to some sort of reality.
There is still a level of shock in my system, that will probably be permanent.
No one can fully estimate the power this drug had to alter all sane thought and behaviour, and I appreciate you wanting to talk about it.
It is not something we just get-over, and move on..
Much too life-altering.
Karl says
Hi Annie that’s very kind off you to get back to me thankyou I had a permanent job for 11 years untill I stopped Seroxat which I had to leave because I was sleeping two hours a night for 18 months. I didn’t claim benefits in this time wish I had off but was to unwell to do anything lived off my savings. Luckily I found someone who took me on a couple off days a week gardening which is all I could manage which I’ve done upto now not the career path I’d have chosen but being an outdoor person didn’t mind this has helped. I also have developed fibromyalgia since quitting and have been left with intrusive thoughts and images I never had. Im self employed now don’t earn loads but far more than if I was on the sick I work a couple off days a week sometimes and some weeks I might work everyday depending on how much work I have or how I’m feeling. Been doing this four years and gradually built it up to be honest if it wasnt for the fact I have kept busy don’t know i would have survived withdrawal and often feel worse on the days I’m off symptomatic which is a shame because I can never really relax I have the odd good day . I find the winter worse since withdrawal and this fibro crap I’ve developed. I was on seroxat 13 years taken nothing now for seven years absolute hell for years coming off never got back to baseline but like you by the sounds off it do my best. I also work outdoors in freezing weather every month off the year even when the fibro makes my legs in the cold feel like there full off super glue I try to never give up think people who have been through this are true warriors thankyou for replying it’s good to be able to relate with others Karl 🙂
Madeline Nasta says
I am going through a demand to not go off Divalproex. 250mg .i am being refused as to how to safely end this horror. , Phys. demands I stay on until out 15th meeting. I disagree and want to stop now..
Will says
Can you go into detail on this comment ?
“I’m almost inclined to think stressing the system and then pulling it back (giving smidge more drug) actually may help.”
This is interesting I’m going nthrough a similar situation but I haven’t been on the drug very long so it should likely be easier.
*- Having alot of knowledge on this would a wean using the extended release be a better idea ? I have access to direct and extended. Your perspective paragraph was the most interesting , thanks.
Kristi says
This has been great information containing important knowledge for my plight. I’ve read everything. I’m very concerned with dropping my adult son from 1000 MG of depakote a day down to 500 MG a day. He takes 500 in the morning and 500 at night. Longterm, I don’t want him to take anything, but we have learned that he is sensitive to medication changes of any kind.
Recently, I talked with his Psychiatrist because I think he has way too much depakote in his system and I feel like he’s losing weight due to the fact that he sleeps a lot and so he doesn’t eat as often as he used to. He was already slender before depakote. I don’t know exactly, I just feel like he’s not healthy and he needs off of everything…eventually. However, I also know from his past experience that he needs to taper off slowly. Ok, so Dr said, stop morning 500 MG tablet and only give him the evening tablet. Well I wanted to taper him off like 25 MG or 50 MG at a time, not 500 MG at a time. So I’m scared to do what the Dr said because of a terrible experience my son had with this 2 years ago, which included rage, breaking out windows, anger, pushing me away, complete confusion, police coming to his house 5 times in a month and a half period, to the point that I talked him into going to Oceans Behavioral hospital instead of the police doing a mental health warrant. This was in 2021 and all happened in a month and half time frame. Important to the story: my son had not had any run ins with the police for 16 years prior to that small time period in 2021, all these years being on Depakote. At that time a new Dr had come on board, and all of a sudden he could no longer get his Depakote. It was as if the computer’s records had not transfered over. When this happened and all hell broke loose 2 months after he didn’t have his depakote, I realized this was NOT a blessing in disguise, and I had to jump into high gear to figure out how to help my son. This included talking to the supervisor at facility, and everyone else that could possibly help was my mission. And when I took him to Oceans BH that was the fix. Longer story shortened, mistake had been made by one of the Drs, situation was remedied Oceans and Dr put him back on the Dapakote, and he moved in with my husband and I. All calmed down, all problems fixed.
Well, except for the fact now 2 years later i just feel like he’s not healthy, sleeping so much, and he seems like he’s losing weight. Not sure but I think that the sleeping so much is causing him to eat less. All is calm, but I want my son to have a full life and be healthy. I’ve always wanted him to eventually be off all the medicine. And now I’ve talked with the dr, and mentioned his health concerns and me wanting to taper him off from the Depakote. Well Dr said stop the morning dosage, and only give him the night dosage. This is why I’m scared to make this big change. 500 mg decrease is too much of an adjustment all at once. So I feel stuck. It’s been about a week since Dr made this recommendation.
Feel like I’m living on the edge a little bit by not yet doing what the Dr said, but my main concern is my son’s wellbeing, and I don’t want all heck to break loose in our household.
I’m going to ask the pharmacist about getting the pill in the 125 MG tablets and 25 MG tablets in order to taper it off slowly ourselves. Not sure if pharmacist will be obliged to help in this way or not. Anyway…any suggestions?
Alfa Zimmerman says
After reading your story, weaning slowly sounds very important, as well as having another drug at the ready as a bridge drug, should he need something to get him through the wean (like a benzo or antipsychotic). If my son was on 1000 mgs, I would decrease his dosage in 125 mg increments. Giving 500 mg at night, and morning would be a 250 mg pill and a 125 mg pill. For a month…..then drop the 125 pill, and stay on 750 mg for a month….then continue decreasing by 125 mg….it would take about 6 months. I have never seen 25 mg tablets, but that would be so helpful for my son, as he’s very sensitive and the slower the better.
Yvonne Nieto says
Go to alternative medication
https://www.alternativetomeds.com/philosophy/
It help you taper off of this medication I am currently doing this for my son
Courtney says
I have been off of Depakote for over a year and am still experiencing the brain zaps at night and when I wake up. I am so frustrated at every psychiatrist for saying I have no idea what you are experiencing. I am now 30 years old living a great life now with brain zaps. I have tried vitamin B and omega 3 fatty acids just for temporary relief. When will these go away? It’s so frustrating. I’m starting to think I need serotonin supplements. What sort of doctor should I see instead of a Psychiatrist?
Kristin Vickstrom says
Hi Courtney.
How long were you on Depakote, what was your dosage and how long did it take you to get off of it? Just wondering how long of a process this will be.
I’ve been on 750mg for about 6months. I need to get off of it now as my hair is falling out! I just dropped from 750 to 500 and the first two days have been miserable.
Adel says
I felt fucked up i went to the doctor, then i felt fucked up and the doctor wouldn’t agree that i felt fucked up. I had to discontinue the damn drugs without telling anyone because i had to be confirmed as a mental patient to get the sick leave without which i will drop out. I don’t work. I can’t work. My parents are dying. And i have to get off these damn drugs. It’s worse than it used to be. I got ect when my parents were younger. I stopped the drugs when i was acceptably young to be an invalid. I’m almost 40 and i’m dropping out of PhD. My parents are senile and cry because i am fucked up mentally. Anyway i decided it is time to stop taking depakene and antipsychotics but i have to keep going to the paychiatrist to get a note for my sick leave.
Laurie Oakley says
This post and others like it are invaluable for reference when helping people decide whether, when, and how to taper.
“But so important is the underlying stability of the person being healed. We in most cases are fragile people who have experienced trauma in many ways and psychological preparedness for the stress of this needs to be established before trying to taper.”
That whole section is excellent.
I’d like to encourage any who are interested, perhaps especially people already working in a peer support capacity, to check out GAM, a method developed in Quebec that empowers service users to assess their overall quality of life, the role of medications in either enhancing or detracting, and to prepare for tapering if that is what they desire.
http://www.rrasmq.com/GAM/documents/GuideREP-ANG_2014-04.pdf
The workbook I’m currently using in a Recovery Center setting is here: http://www.rrasmq.com/GAM/documentation.php#TakingBackControl
RxISK and David Healy are mentioned in a section on a patient’s rights for information on medication:
“Access to information on prescribed medications is often a basic need for
medication users. Access to the most comprehensive and objective information
about drug treatment, its benefits and risks, and the various alternative or
complementary therapeutic options available is a right for people who are
prescribed medicines, psychotropic or otherwise… doctors do not always
have the time to provide all the necessary information on the medications
they prescribe. It is therefore important that mental health providers who
advise medication users ensure that they receive and understand the available
information on the drugs prescribed, their instructions for use, desired effects
and side effects, drug interactions, and different treatment options, if so desired.
There are several sources of information on psychotropic drugs, including
pharmacists, reference books such as the Compendium of Pharmaceuticals
and Specialties, the Guide critique des médicaments de l’âme (Critical Guide
of Psychiatric Medication; Cohen et al, 1995), Psychiatric Drugs Explained
(Healy, 2008)* courses on psychiatric medication, and the Internet**. This
information can also be conveyed by different means: during individual
follow-up meetings, through workshops on medications, or by way of posters
displayed in organizations or establishments.
* Sources of information regarding psychiatric medication must be reliable and varied in order to get a full picture. User accounts, information from a critical perspective, along with more mainstream sources, are all useful.
** As an example, the Web site http://www.davidhealy.org and the tab “RxRisk Papers” can be consulted as an introduction to the general information and issues surrounding the different classes of psychiatric medication.”
From what I have read, GAM is used primarily in Canada, and there are some projects in Spain and Brazil. The language is less polarizing than a lot of what is typically seen in prescribed harm circles and has enough backing in Quebec as to be accepted in more mainstream settings.
susanne says
NHS bill for US drugs ‘could soar under post-Brexit trade deal’
Dispatches investigation finds ‘drug pricing’ has been discussed in six initial meetings between trade officials from the UK and US.
By Paul Gallagher
Monday, 28th October 2019, 11:22 am
Updated
22 hours ago
The price the NHS pays for US medicines could soar under a trade deal with the United States after the UK leaves the European Union, according to an investigation.
Despite Boris Johnson’s assertion that the NHS is not on the table, sources with knowledge of the initial trade discussions between the two countries question whether the Prime Minister is able to keep to that promise. In fact “drug pricing” has been discussed in six initial meetings between trade officials from the two countries and secret meetings between US drugs firms and British civil servants where medicine “price caps” have been talked about, according to Dispatches.
The programme, broadcast on Channel 4 on Monday night, was also told that British trade officials have been warned that the subject is so sensitive that they must not mention “drug pricing” in emails but use the term “valuing innovation”.
NHS staff and health campaigners fear the US government and its powerful pharmaceutical industry want the health service to pay more for their drugs, which are much more expensive in the US. Currently, the UK can block American drugs not deemed “value for money” and allow cheaper alternatives to be prescribed to patients which save the NHS hundreds of millions of pounds a year. However, the system could be under threat under a new transatlantic trade deal.
According to research carried out for the programme, the cost to the UK government could be approximately £27bn, wiping out the potential Brexit bonus for the NHS promised by Mr Johnson. In an interview with the programme, one of Donald Trump’s former top trade negotiators Stephen Vaughn said he does not understand what Mr Johnson means when he says the “NHS is not on the table
Stephen Vaughn, former general counsel for the Office of the US Trade Representative, said: “That that really goes to the question of what the UK government means when it says the NHS is off the table. I don’t know what they thought they meant when they said that. “
Until April this year, Mr Vaughn was the top lawyer in the Office of the US Trade Representative and a key player in recent trade deals with Canada, Mexico and South Korea which saw the US win key concessions over the price those countries paid for US medicines.
Mr Vaughn said: “I would expect US negotiators to see what we could do in terms of getting increased access to the British market. That’s what we do… I think it’s going to be likely to come up because the US mentioned pharmaceuticals in its negotiating objectives”
The programme focuses on the drug Humira, used to treat 46,000 patients in the UK who suffer from diseases like rheumatoid arthritis and Crohn’s disease, made by US drugs company AbbVie. It is the single most expensive drug for the NHS costing £450m a year. Last year, the NHS started prescribing cheaper alternatives to Humira that will save the health service £150m a year.
Cheap alternatives
Unlike in the UK, patients in the US will not be allowed to be prescribed cheaper alternatives to Humira until 2023. Trade experts fear that should a trade deal be signed with America, then the US administration will force Britain to adopt similar policies.
Dr Andrew Hill, from Liverpool University, estimates that adopting the US system of drug pricing could cost the NHS £2.9bn alone for Humira. He also calculates that if the US government and drug firms get their way in trade negotiations, the total extra cost to the UK could be £27bn.
Matt Hancock has said “the NHS is not for sale” and that the health service would not be on the table in any future trade talks. The Health Secretary was responding to comments by the US Ambassador that freer access to the NHS will be part of any post-Brexit US-UK trade deal. Woody Johnson – a member of the Johnson & Johnson pharmaceutical family – said that healthcare – along with “all things that are traded” – would be on the table in negotiations for a deal.
A no deal Brexit would have devastating consequences for medical supplies in the UK, experts have warned. It could lead to a shortage of some drugs, which might not have the required regulatory approval by the end of January 2020 to continue being brought in from the EU, or price rises in the event of drugs needing to go through a new licensing process. If the UK leaves with a deal any disruption will be lessened.
A spokesperson for the Department for International Trade said: “The NHS is not, and never will be, for sale to the private sector, whether overseas or domestic… The sustainability of the NHS is an absolute priority for the government. We could not agree to any proposals on medicines pricing or access that would put NHS finances at risk or reduce clinician and patient choice.”
Boris JohnsonBrexitMatt HancockNHSTrade DealUnited
Couple that with this and as useless as the MHRA and other regulators have been, and that EMA are flagging up that they won’t be able to do a proper job in future – anybody using drugs is even more so pharmas’ rich pickings. With collusion of medics.( Johnson and Johnson are involved always a marker to note)
Britain’s leading role in evaluating new medicines for sale to patients across the EU has collapsed with no more work coming from Europe because of Brexit, it has emerged.
The decision by the European Medicines Agency to cut Britain out of its contracts seven months ahead of Brexit is a devastating blow to British pharmaceutical companies already reeling from the loss of the EMA’s HQ in London and with it 900 jobs.
All drugs sold in Europe have to go through a lengthy EMA authorisation process before use by health services, and the Medicines & Healthcare products Regulatory Agency (MHRA) in Britain has built up a leading role in this work, with 20-30% of all assessments in the EU.
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The MHRA won just two contracts this year and the EMA said that that work was now off limits. “We couldn’t even allocate the work now for new drugs because the expert has to be available throughout the evaluation period and sometimes that can take a year,” said a spokeswoman.
In a devastating second blow, existing contracts with the MHRA are also being reallocated to bloc members.
Martin McKee, the professor of European health at the London School of Hygiene and Tropical Medicine, who has given evidence to select committees about Brexit, said it was a disaster for the MHRA, which had about £14m a year from the EMA.
The head of the Association of British Pharmaceutical Industry said it was akin to watching a “British success story” being broken up.
Mike Thompson, the chief executive of the association, said: “Clearly we’ve all been incredibly proud of the MHRA’s role over the last few years. They’d established themselves as one of the most respected regulators across all of Europe and industry. It’s been a British success story.”
The EMA said that because of the long lead-time involved in assessing medicines it could no longer award the lead contracts to British people since there was no guarantee they would be part of the EU after March 2019.
It is understood the MHRA bid for 36 EMA contracts this year but were only awarded two, and these were for drugs for which evaluation had already begun.
The situation is a stark contrast to 2016 when the UK was the lead assessor, known as the rapporteur, on 22 applications, and was joint lead or co-rapporteur on 19 multinational applications. This made it the number one in Europe, with Germany’s regulator behind with 22 lead contracts but only 12 co-contracts.
European Medicines Agency applications for medicines marketing approval.
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European Medicines Agency applications for medicines marketing approval. Photograph: EMA/European Medicines Agency
The EMA now also requires all existing drugs assessors to transfer their personal knowledge of their specialist fields to counterparts in a European member state.
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“You might have been working on a cancer drug for decades and built up so much expertise and you are the absolute specialist in your field and now have to transfer all your knowledge to someone else. It must be like handing over your baby,” said one source in the EMA.
Thompson suggested the removal of the MHRA from the approvals system was the EU’s loss. The MHRA did one-third of all the manufacturing inspections and in terms of patient safety they had picked up one third of all “adverse events”. He said: “This is a pre-eminent regulator. As part of the withdrawal agreement the UK regulator … they will just be an observer in that system.”
McKee said: “The MHRA has benefited enormously from its close links with the EMA. The fracturing of those links will impact severely. on its budget, much now from the EMA, and its ability to attract and retain skilled staff.”
The loss of these valuable specialist contracts underlines the punishing impact Brexit is having on services that supports the pharma industry in Britain.
The EMA has already started its move from Britain to its new headquarters in Amsterdam. It employs 900 staff in its Canary Wharf offices, in London, and 84 have already relocated to the Dutch capital, the EMA said. It expected that about 300 of its staff would be unable to relocate and have to find new jobs because of Brexit.
The ABPI said the change in approvals meant a huge cost to the medicines companies.
Thompson said: “Companies are having to build extra laboratories to try to prepare to batch-release medicines made in the UK on the continent. That’s a huge cost for us. Hundreds of millions of pounds that we’re having to spend that frankly we’d rather spend on researching new medicines. We have no choice because we have to ensure what we do is legal. It’s probably wasted money in the end.
“We regret that, because the MHRA is a highly respected agency. We’d hope that could be resolved as soon as possible. Ultimately it will be difficult for them to hang on to the capability that they have spent many years building up.”
The MHRA said it hoped its relationship with the EMA could be salvaged in negotiations.
An MHRA statement said: “We want to retain a close working partnership with the EU to ensure patients continue to have timely access to safe medicines and medical devices. This involves us making sure our regulators continue to work together, as they do with regulators internationally, and we would like to explore with the EU the terms on which the UK could continue to participate in the EMA.”
Carla says
So eloquently stated:
We in most cases are fragile people who have experienced trauma in many ways and psychological preparedness for the stress of this needs to be established before trying to taper. It’s monumentally hard. Internal and external resources are so important in the way of supportive family, friends, work, professionally – psychiatrist, psychologists, therapists.
Sadly, many are left in the lurch, especially, when no one appreciates or fully comprehends, ones dilemma. Many are ‘walking wounded’ and sadly once harmed, are no longer willing to TRUST! If all the healing professions and people who are prescribed these medicines, were to come to RXISK and utilise it as an educational resource, many would take heed and have a totally different perspective of how we perceive medicines and procedures.
We are generally told to ‘trust’ and conform to – and not challenge or question.
Tammy says
Thank you for this info. and your willingness to share it with others. We must be proactive in our health care. My son has been on Depakote with unfavorable results, even at a low dosage. I was doing a search to see how to wean him off of it because he wanted to just stop taking it. He has been on it a month. I recently found out about a DNA test (done by a mouth swab) called Gene Sight (? Spelling) that tells you which classes of meds would be the best for each individual. It gives you a red level which means you definitely should not take any meds in that class of meds, a yellow level which may or may not work for you, and a green level which will work for your benefit. The psychiatrist we “were” seeing used this test on others but didn’t mention it to either of us. I have been on so many antidepressants and was told I about exhausted them all, but never offered this test. I encourage you to look it up. We are looking forward to the results. I’m told the test has been out for 2-3 years.
Brett A Liddle says
Thank you – I’ve only been on Depakote for about a month and am already having bowel/stomach issues because I’m taking an aspirin regimen (for 1 bout of Paroximal Afib)….I’m already done with this drug and will wean off ASAP….lived most of my life anti-depressant free…things were tough some times, but things are tough for EVERYONE sometimes…diet, exercise and competent talk therapy are my direction, now (again, actually) — Thank you, again —-
roslyn cantu says
Hello
My 12 year daughter been on depakote for almost 3 weeks and its a nightmare, she just said shes hearing a loud whistle in her mind and funny laughs, scares me like hell, how i can detox her, shes been diagnose with petit mal im going on natural ways, i dont want to drug my baby
Jessica says
I know of a detox through a mlm company.
Jonathan Carofino says
I am 15 days off depakote from a taper. been on it 3 months. still having bad withdrawal. how long does withdrawal usually last until your 100% back to normal?
Angie says
Hello!
This is Angie from Cairo, Egypt. First of all, thank you so much for sharing this with us. It’s quite helpful as I am currently withdrawing depakine too. Second, here is my story. I was diagnosed with MS 20 years ago and have been on depakine ever since then as I had few seizures episodes early on. However, some doctors doubt it, and they think it could possibly be psychological, in principle which turns out to be the case. After all, it’s totally normal for someone to get seizures especially if their childhood is not the best. So, as a philosopher, a naturalist in deed, I am now taking good care of my health ( nutrition and workout) while withdrawing depakine. I feel so much better now. I take keppra as a substitute but that will be for a short while until I quit it, too.
So, you are not alone. Getting the right diagnosis isn’t an easy task. For me, my parents are doctors and professors as well. But they used to believe in the power of MRIs and all that. For me, empiricism fails big time because we are more than the physiological problem or whatever that is. Let me share with you this; honey and herbs helped alot with my symptoms-unconventional medicine they call it. But it’s worth it!
I am a writer, and will be publishing a story on that next week. I want to raise awareness on that issue, and my motivation rests on that emotional hell I have been through because of depakine! It is a killer.
Cheers,
Dr. David Healy says
It would be great to get a link to your story when its published
David
patricia ellison says
Thank you for this.
Did you have to change from Depakote extended release to direct release to taper please, I have and want to taper as my shaking is terrible after being on these meds for 14 years,. I am on 500mg of extended release so therefore it would be a jump of 250mg to the lower dose.
Kind regards.
Helen says
l had been taking Depakote for migraines for 23 years l know do not have migraines but my body is totally hooked on Depakote (l was never told by my head pain doctor that Depakote was addictive)l had zero support from my doctor just said take half the dose for a week then quit! Luckily l read everything l could on line about tapering of the drug, and my regular Doctor has backed me. This is where l am at the moment, six months a go l started stepping down the dose from 500mg to 250 mg delayed release, l was not able to find a direct release Depakote pill. I kept cutting the 250 pill in half untill the side affects lessened then went to the 125 mg pill, l hailed it and then Quartered it, you have to get a really sharp pill cutter. Each time l cut down the 125 mg pill the side affects got wors because your body is going into drug starvation mode. It’s been hell but l will not give up, l spend half the day in a fog like state l feel like curling up in bed, but l fight that feeling and it is a fight. So right now l take 31.5 mg per day l can not cut the pill any smaller so my plan is to take 31.5mg every other day untill l can finally quit. I hope this has been of some help, good luck.
Ruth heritage says
Hi I was on olanzapine for year and half for anxiety tapered down 6 months and been off it 5 months still have nausea in mornings and no appetite my son said to go on depakote for gaba cause it worked for him he’s been on it 9 years now taking cbd capsules good for anxiety but got to get rid of this nausea I have no life
Jessica says
I have awful pain in my ankles, ontop of my other chronic illnesses (constant vertigo) that makes being active awfully hard. I’m trying to figure out if the pain will ever go away? I was only on depakote a month & been off it about a month now.
April says
I have searched far and wide for information on this very topic and unfortunately there is little on it. I am thankful for this post. I decided recently to taper and eventually quit depakote. My sister who has worked in elder care for many years has seen the detrimental effects of long term depakote in elderly. And I am appalled at how Abbot Labs, maker of depakote, falsely claimed the off label use of this drug to doctors. I was put on it 2 years ago by a psych during a difficult period in my marriage that I thought was ending in divorce. I had no choice because I was in the hospital and they told me that I had to take it or be forced to remain there for 30 days while they went to the court to get an order. if I said yes the. I could go home in 72 hours. It was obvious what I chose! I have been afraid to get off of it because of the withdrawals but I am going to do it gradually, even if it take the whole year.
Gay says
Hello April .
The same happened to my son.
I wish you success with the withdrawals , having a rough time with withdrawal symptoms with my son , terrible noises and voices in the head and no sleep , doctors are useless the don’t want to know , just want you to take the poison and vegetate.
Heartbreaking.
Patty C says
My son too was put on 750 mg, he was on for 7 days and could not stand it anymore, cold turkey which has turned into a stay at the local behavorial health hospital, stay away from this drug!
No sleep, cannot eat
Tabetha says
I’ve been on a different cocktail of Antidepressants and anti anxiety medications since 2006, here I am 2021 and still depressed and have anxiety. I believe the doctors believe I’m full of it. My family could sure tell them different. I’m sick if taking medications, especially when they don’t help and the side effects suck. I believe I have side effects from each one I’m on now. I’m on 300mg Wellbutrin, 1000mg Depakote, 20 mg Prozac and .5 mg Xanax times 3 per day.
Anna Dias says
Hello Tabetha. Your situations sounds strikingly like my daughter’s. She too has been on different cocktails and for many years and is still depressed and anxious. She has been suffering non stop since last May and although the doctors keep changing her meds she has not improved. At the moment she too is taking 1000mg Depakote, 15 mg Brextill (a new antidepressant) and 2,5 mg Seroquel. Have you considered coming off your meds? If doctors keep changing the meds how do you know what is a side effect or a withdrawal symptom or a relapse? It has been hard on all of us in the family. I hope you are doing better. It would be good to hear about your progress. Thank you Anna
Patrick says
I can’t concentrate enough to type all that I think. I went the med route all through child to mod 20s became terminally ill weaned off drugs to reduce toxins took 2 years plus all the symptoms. Researched natural methods by far my most successful therapy was purified water with active chlorine dioxide to assist in detox. Mental clarity bad cholesterol levels lowered stress reduced or my bodies response was less overload. Skip 19 years a tragedy losing my son triggered me and I’ve spiraled unable to naturally suppressed cope with this sought medical help and yes the drugs are back and the Dr never acknowledged me or my life just my old diagnosis BP and just tossed me Gabapentin and hydroxyzine. Then Neurologist added Depakote saw me for like 1 minute. Side-effects landed me in ER and suicide watch and increased meds under supervision. Side-effects got worse removed me off Gabapentin finally 5 months to feel not suicidal but still have a day or 2 a month. Depakote 1000mg now and had a psych episode and disassociate episode almost got hit by id say vehicle as I was found in the middle of the highway. Head was burning explosive feeling and rage. I think I stopped my Depakote for at least 5 days not on purpose just having lost time episodes. Memory issues. No seizures that I am aware of but scared now to start taking again. Will this be worse or improve and IM unable to contact my Psych. As everyone is remote nowadays and u call a call center its horrible to stay panicked. I am saving this site to read later when I can. But a natural approach is what I am searching. I have to get off these meds. Peace to all
Debra Gallacher says
I am bipolar.
I have tried everything with side effects that lead to having to stop except Depacote. I have been put up to 1000mg over a year. My hair has fallen out to point that I can’t even recognize myself.
My weight is 203 lbs. So losing weight is hard even though I was 200 something when I began depacote. I have uncontrollable tremors and jerks along with nightmare dreams. I have no sex drive at all. I have had a decrease in my vision by 2 fold. My eye prescription has changed twice in one year. I have had broken bones.
Caley says
My highest dose was 2500mg. I didn’t even know how dangerous this was until my pharmacist showed concern for me. I fired the psychiatrist I was seeing and asked my GP for another one. My new psychiatrist helped me over the past two years to taper off, 125mg at a time, once per month. In finally in the final month, but we are doing 125mg decreases once per week now. From 500 to 0 in four weeks…. He is retiring so we needed to speed things up. It has been tough.
The hair loss has stopped but it got so bad. I blamed trauma for the hair loss until someone showed me a list of side effects from this drug. I wish I never started on it. Worst part? I don’t have bipolar 2 at all. I just got a diagnosis of ADHD-C and C-PTSD. I had to fight for the proper testing to sort this out.
I’m nervous about what the next couple weeks will bring. I just decreased to 250mg tonight.
Stephanie says
Thank you for this post! I’ve been on depakote for 3 years. I’m at 2000 mg a day and the side effects are just unbearable. Stomach issues, weight gain, severe headaches, tingling and itching, hair loss, vision problems,really too much to list. I’ve tried to stop cold turkey and that almost drove me to the breaking point. My psychiatrist doesn’t want to switch meds because he believes that it’s working too well for me. But this medication is scaring me more and more. It’s definitely time for a change and this post reassured me of that. I wish that doctors would listen more and understand how these medications affect us. Yes my mood has been stable, but my body feels like it’s being destroyed in the process. Thank you again for this. I’m glad that I’m not alone.
Makayla says
I’m always interested in other peoples’ perspectives on medications, and reactions. I’ve only been on Depakote for 3 months, on my starting dosage, and tappered off after a week and a half to two weeks. I’ve been noticing a headache that comes and goes, but is progressively getting worse, as well as vision that is strange, thats the best way I can put it. I’ve also been sensitive to sunlight lately. I decided to get off of Depakote due to weight gain, edemas in my ankles to the point I look like I’ve been stung in both feet by large aggressive wasps, hair loss, and to switch provides since my psychiatrist tells me nothing when I ask about side effects, or anything to watch out for. I’m currently trying to find a provider that has better hours then 8am-4pm. This is the worst provider i’ve had to deal with. There’s only one person who answers the phone all day, and you never get connected to them, so they call you back hours later. If you can’t get this call on time, or can’t have your phone at work with you, you’re screwed and have to start the process over, again and again, and half the time you just deal with whatever is bothering you until your next appointment. Now, I’m taking Lamotrigine, and I hope it goes better then Depakote. I’ve only been being treated for Bipolar for a few months, so these classifications of drugs are going to take some getting use to. before this I was on Paxil, Lexapro, and Cymbalta, which was treating anxiety and depression. Paxil was a living nightmare, it worked, the symptoms got worse as I took the medication. At one point, I had lucid, strange, nightmares. I also felt like I had electricity running though my veins, bugs crawling on me, ringing in the ears, headaches, and my arms and legs would flail in the middle of the night stratling and waking me up. Best of luck to any out this trying to figure out how to live a “normal” life, it’s tough.
Anne Bosworth says
I have been taking Depakote ER (500 mg per night) for about 4 months to help me sleep at night and to relax my stressed muscles. I knew I only needed this for a period in my life, and now I want to get off of it entirely. It definitely helped calm my muscles at night and helped me sleep well, but I prefer to not take medications for long periods if possible. With the help of my PCP, I began tapering off from 500 to 250 (for 2 weeks) down to 125 (for 2 weeks), and then eventually off 2 weeks later. I have started developing pins and needles all over my body at random times (especially in the feet and legs). Its so odd and it is hit and miss, but it feels like numbness just beneath the skin. I even began to wonder if I may have MS (as my dad had it) or some other nerve damage. I believe now that it is withdrawal symptoms to the Depakote ER because of when the symptoms began. I will consult my doctor and seek more professional opinions, but I do believe that is what I am experiencing. I hope this helps if anyone else is dealing with these symptoms when tapering off of this drug.
Irene says
It is very comforting to find this site where similar experiences are reported. I hope that they can be read by those responsible who put patients through such misery.
My experience with lithium was relatively good (though too long and too high–41 yrs.. But I had to stop as I became “alergic” to it and my kidneys were affected. Since then, I had terrible times as my GP dr. retired just when I needed someone to taper me off lithium. I had to do it myself and could not find a medical soul what with the pandemic starting. Hypomania or possibly withdrawal put me at a year’s w/d of insomnia and hyperactivity which must have been hypomania. Ironically, the help that I did get via an authoritative hospital with a historically bad reputation during the 60s, made things worse. I was put on divalproex sodium, and being diabetic it did a lot of harm and the psychs. would not let me off it. I had to discontinue my association with the hospital to stop the drug after 6 months of torture. And now, I am withdrawing. My perception, is that few doctors have the gall to make individual decisions based on the patient’s case, and only make them on the base of bureaucratic guidelines. In my case, I have often woken up slowly getting better, only to regret that I woke up at all.
Irene says
https://www.justice.gov/opa/pr/abbott-labs-pay-15-billion-resolve-criminal-civil-investigations-label-promotion-depakote
Depakote for target populations:
I can only imagine what effects this drug has on elderly people with dementia, as the primary effect is to knock you out in a comatose state for several hours (what the monograph describes as sleepiness). And I wonder what other target populations are chosen for such potent drugs.
Roman Ramirez says
Hey guys reading all of these comments brings great relief.
I was on depakote 500mg twice a day for two months and I went cold turkey.
I feel like I’m losing my mind. The withdrawls have been coming in waves. I’ve been having withdrawls for 1 month and 1 weeks and im losing my patience.
The first week of withdrawls was really heavy, I would apart crying for no reason and I would cry uncomfortably.
Some days I feel like I can conquer the world and other days I feel so weak and vulnerable. The depression that comes from my wothdrawls is so deep that it scares me into thinking that I’ll feel like this for the rest of my life. I feel so hopeless. I try to constantly remind myself that I’m only going through withdrawls and they will not be there for ever but it gets hard when I get sucked in so deep from the depression. The anxiety is also pretty heavy. The weakness also comes and goes in waves. Some days I can hit the gym really hard and I feel so accomplished and other days it’s ridiculously hard to even convince myself to go to the gym.
My withdrawls have been diminishing as the weeks go by but sometimes there’s a hard peak that comes along.
I wish there was a definitive date that the withdrawls came to an end but from here it’s literally a waiting game.
No matter how hard it gets I will never quit and I always try my best to at least stand up when my withdrawls hit me. I pace around or I stand up and just sit outside for some fresh air.
At the moment I’m struggling with feeling comfortable with natural boredom. It feels like life isn’t exciting. I feel uncomfortable just being bored or idling. I’m trying to get used to the idea that boredom exists and it’s okay to just sit down and watch a movie, a show, or just be on my phone scrolling through social media.
I can’t wait for these withdrawls to finally go away. It’s been a roller coaster of uncomfortable emotions.
Laurie christiansen says
Weaned off 500 mg depakote after being on for 13 yrs, been off 16 days have dizziness sometimes unstableness and muscle feel like blocks on shoulders and back low energy painful muscles, doctkr said i have deconditioned muscle too im in ohysical theraphy for range of motion,. Others experience this how long last? Any suggestions
Will says
Ok so im in the middle of doing this right now, so i only have the energy to type so much, i just detoxed from zyprexa a few months ago, ive been on meds like this over 20 years, my parents did it to keep me a zombie to avoid parenting and understanding what was going on at home, ive already been sober 5 years, doing this is much harder, i began having severe gi issues over the past few years and it was determined this was the cause, i saw my primary care today and the medical results speak for themselves, my gi returned to completely normal after the zyprexa detox, and the primary care said that my blood pressure and colesterol levels went back to normal for the first time since she started medicating me for those, when i told her what i had been doing that caused it she was dumbfounded, and said its not something she would medically recommend i be doing, but she couldnt argue with the evidence of the results, this depakot detox is not fun, im pretty much bedridden right now, but i know im doing the best thing for myself, and my wife supports and agrees
Rachel Merton says
So helpful to read all your experiences. My mum has been on Depakote 500 mg ER twice a day for at least 10 years.. She reached a critical point in February where she was sleeping so much, she couldn’t stay awake enough to eat or drink, and her hair was falling out at an alarming rate. She was prescribed Depakote for seizures that started after having a ruptured cerebral aneurysm 20 years ago, she was also also taking Topamax for migraine prevention. Her neurologist just cut her Depakote dose in half (to 250mg BID) and she has had several headaches the last week and a terrible one last night where she suffered from brains zaps. I’m curious if anyone else out there has had headaches and brain zaps after lowering the dose of Depakote. Do the headaches subside after a longer period of withdrawal?