But in the mid 1980s the waves of controversy broke over company defenses and the benzos rather quickly became one of the greatest threats to civilization. They ended up being viewed as more addictive than Heroin. An untold aspect of this story is the role that companies making new drugs active on the serotonin system, from Buspar to Prozac, played in fueling this controversy. Valium ultimately became so stigmatized, Roche retired the brand name and you can only now get diazepam.

A complex picture

Everything happened astonishingly fast in the end. As Margrethe Nielsen has pointed out, as late as 1980 the British regulator estimated that there were 28 people dependent on benzos in the UK. Not much of a cause for concern. Only a few years later there were major lawsuits with thousands of people involved were launched against the makers of the benzos.

Despite this, when the the controversies were at their height, the regulator came out and said that they had warned people about the problems with benzodiazepines many years earlier – the 28 people. This is classic regulatory behavior – when convenient they will say that barely perceptible hints they issued previously were in fact warnings. They have no doubt been warning about the risk of birth defects from antidepressants and the cognitive problems on statins for decades.

The picture is complex. Benzodiazepines are in many respects a lot safer than the barbiturates that killed Marilyn Monroe in 1962 or thalidomide that was one of their main competitors in 1961. In contrast the withdrawal problems they give rise to seem, for some, to be even worse than with opiates or most other illegal drugs.

What would GPs choose?

Today, if forced to choose between having Diazepam or Prozac for a year, nine out of ten of the general public would likely pick Prozac. In contrast nine out of ten mental health professionals would like pick Diazepam. The key group are primary care physicians who dish out most SSRIs. Which group do they think are worst?

Where the benzos are seen as dark drugs and the SSRIs are much better, there is a good case for saying the SSRIs are at least as dark and perhaps more so.

Health warnings

The data for the benzodiazepines below has gaps in it. We are missing a number of drugs, especially sleeping pills (temazepam). We are also missing data on some European only benzodiazepines (zopiclone). We have however European Medicines Agency data which we hope to make available soon – the only site that will offer both US and European data.

But the key point is this. The heyday of benzodiazepine adverse event reporting was in the 1980s. The data in this table and the data that other FDA portals offer is from 2004. We have however all FDA data from 1969 and hope to be able to make this available through a research portal soon. At this point it will become possible to get a truer picture of the scale of the problems the Benzos have caused.

SoS: Benzodiazepines

Click here to listen.

RxISK Media Relations officer, David Carmichael tells personal tragic story on prescription drug induced psychosis to radio show host Dr. Lorraine Hurley.

Click here to listen.

Answers to these 12 questions could save your life

The medical team behind RxISK.org, today published a checklist to help patients and their health care professionals assess the risks and benefits of prescription medications.  RxISK is the first free, independent website where patients, doctors, and pharmacists can research prescription drugs and easily report a drug side effect.   RxISK provides an individualized causality report for drug side effects enabling the health care team to act sooner.

“If your government allows it, your doctor prescribed it,
and your pharmacist dispensed it, then it must be safe.  Right?“

If your government allows it, your doctor prescribed it, and your pharmacist dispensed it, then it must be safe.  Right?  Not necessarily!  This assumption is wrong.  People die because of this wrong assumption.

Know your Rx RxISK

RxISK Chief Medical Officer Dr. Dee Mangin says “Prescription drug side effects are now a leading cause of death, disability, and illness along with cancer, heart disease and stroke.”  RxISK CEO Dr. David Healy adds “In mental health care, drug side effects are the leading cause of death.”

The RxISK medical team estimates that, each year, 10,000 people die in Canada, 100,000 die in the United States, and 150,000 die in Europe from taking prescription medications as directed.

“Fewer than 5% of “serious” adverse events (those causing hospitalization, disability, or death) are ever reported. The rate of reporting the millions of “medically mild” adverse drug events that occur each year — ones that compromise a person’s  functioning, self-confidence, judgment, and even ability to care – is practically non-existent,” says Dr. Mangin. “Little is known about the effects of drugs on our hair, sex and relationships, extreme acts or thoughts, and our skin and nails, because these effects are not considered medically significant and are not tracked,” she adds.

Dr. David Healy says, “Some of the known or suspected drug side effects are included in the drug manufacturer’s patient information leaflets.  But a review of the over 15.8 million drug side effects reported to the Food and Drug Administration and included in RxISK’s databank, show hundreds more not in the leaflets that are linked to prescription drugs.”

RxISK tools to research and report Rx drug side effects

Dr. Healy says, “Patients about to start taking a drug have a right to an informed choice.  Only then can they weigh the benefits of a prescription drug against potential harms.  For those already on prescription drugs it’s about being on the lookout for links between side effects they are experiencing and their prescription drugs and being aware of potential symptoms on stopping or changing dose.”

Dr. Mangin says, “The checklist together with the RxISK Causality Report and research tools on RxISK.org can help the patient and doctor in their discussion.”

Checklist

1. How does this drug work, how much improvement can I expect, and how soon?
2. If I don’t take this drug now, and instead wait for a while, what will happen?
3. What are the most likely side effects?
4. Are there any rare serious side effects?
5. Are there any permanent problems this drug can cause?
6. If this is a new drug, why can’t I take an older drug?
7. Can I try a lower dose?
8. What date will we review my use/dose of this drug?
9. Are there problems stopping the drug or any special considerations on stopping or changing dose that I should watch for?
10. Are there any potential interactions with food, my other medical conditions, or my current medications?
11. Might this drug affect my weight/sleep/ hair/ skin/ nails/, mood/ sex life and/or relationships, and if so, how?
12. Do I need to stop this drug before I get pregnant?

Both you and your Dr. can use the free drug research function at RxISK.org to help in this process. This provides access to 4.2 million reports on 5.6 million suspected drugs, suspected of causing 15.8 million side effects submitted to the US and RxISK side effects databases. RxISK also includes the FDA drug leaflets and any “black box” warnings, a European Medicines Agency manufacturer’s admitted side effects data set, and the anonymous stories of others’ experiences.

When you visit RxISK.org home page, you can enter the name of the prescription drug you are about to take, or are taking, on the home page, press enter and you are presented with RxISK research view.  Use this view:

• to see what this drug is used for, by clicking on Indications and Usage in the FDA leaflet or clicking Patient Leaflet (Drug Specific).
• to browse a list of the most common side effects reported on this drug, use Tag Cloud in the graphic or table.
• to see how likely a causal link is switch to PRR view.
• to look up a specific side effect that concerns you, use the A-Z Side Effects search function.
• to see which patients report these side effects most often.  Click on Age, Gender,or Weight.
• to see where in the world these reports are coming from. Click on Heat Map.
• to see possible interactions with food, drugs, or conditions. Click on the Interaction Checker.
• to see possible effects on hair, skin, nails, mood, sex & relationships, or withdrawing from a drug. Click on the corresponding Zone.

Help yourself while helping others

RxISK helps you research prescription drugs, but you can do so much more by reporting a drug side effect and adding your anonymized experience to the data on prescription drugs.

About Data Based Medicine Americas Ltd.

RxISK.org is owned and operated by Data Based Medicine Americas Ltd. (DBM). DBM’s founders have international reputations in early drug-side-effect detection and risk mitigation, pharmacovigilance, and patient-centered care. Although drug side effects are known to be a leading cause of death and disability, less than 5% of serious drug side effects are reported. DBM’s mission is to capture this missing data directly from patients through RxISK.org’s free drug side effect reporting tool and use this data to help make medicines safer for all of us.

Media contact

David Carmichael
david.carmichael@RxISK.org
+1 (647) 799-3792

Read more: Daily Mail Online:  What is wrong with randomised trails Part 2

Fiona’s story

I had a heart attack two years ago and was prescribed Clopidogrel and low dose Aspirin as my after care. Several months ago it was decided that I should come off the Clopidogrel. I was keen to do so as I had begun to get tinnitus and my research suggested that aspirin-like drugs could cause this. As I was told I would have no side effects, I stopped it dead. Three times that week I was admitted by ambulance to hospital with numbness down my left side and headaches. I had an emergency brain scan – all normal. I asked if it could be withdrawal from the Clopidogrel. They said no.

I went back on it. I then started to wean myself slower. As I did the tinnitus stopped. But then I was admitted to hospital again. Worse I had acute anxiety, suicidal thoughts and hallucinations. My doctor told me to go back on Clopidogrel and when I did the symptoms stopped but the tinnitus came back. I then tried an even slower withdrawal. Again I was admitted to hospital – this time with sweats, agitation, anxiety, pain, and headaches. I was told this is in my head and is anxiety in case I have another heart attack – absolute rubbish. This is following a pattern. I know it’s this drug.

The combination of Clopidogrel and aspirin I was told could cause gut problems and has caused me gut problems. But every time I try lansoprazole or omeprazole I get anxiety, hallucinations and numbness.

Can you offer me any advice or where to get help? I know I am chemically dependent on this drug. I don’t want to be on this for the rest of my life as was suggested by the cardiologist. You don’t have a problem on it so keep taking it, he said. What happens if the drug manufacture changes or I become tolerant and need more? What happens if I need surgery and have to stop it in case I have a bleed? I know my body would not take the shock of it stopping suddenly.

I was addicted to the benzodiazepines in the 1980s. It took me 3 years of hell to come off them so I know what withdrawal feels like and this is it. Please can you help? I don’t know who else to ask that will believe me.

RxISK response

The first point to make is that the options are to agree that this is a withdrawal syndrome or else to disbelieve FB. For FB, the stakes are high, including death and significant disability. For the doctors there are no bad consequences of disbelieving her. Indeed one of the consequences of believing her might be to start doubting the standard line about Clopidogrel and other drugs.

Second, FB presents a compelling case for a withdrawal syndrome from clopidogrel. The problems emerge on stopping a drug she had no reason to think could cause a problem, clear up on going back on the drug and reappear on reducing again, and this happens more than once. This is as compelling as it gets.

The first defense for those who don’t want to believe is to say that we cannot see how it could be happening and therefore the problems are not what they might appear to be. Taking this approach requires an alternate explanation – and in this case there is a temptation to pick on the anxiety symptoms and perhaps even the prior history of dependence on benzodiazepines. Someone with less inner conviction than FB may even be persuadable that this is all in her mind.

But there are ways to explain what is happening. Among the types of withdrawal is one that is sometimes termed rebound (DBM Medicine Induced Stress Syndromes; DBM Dependence and Withdrawal). This can lead to rebound heart rate increases in drugs like beta-blockers that slow heart rate and rebound clotting in drugs that reduce clotting. And in fact rebound clotting is well recognized on drugs like aspirin. Another that might fit the bill here is a legacy effect – an enduring effect after a drug is stopped.

Searching in RxISK under Clopidogrel shows that a withdrawal syndrome has been reported on a number of occasions (7 – in FDA’s database these reports come from Europe). European regulators may have many more reports. This frequency is so low that its proportional reporting ratio is close to 0. There is in other words no signal. On the basis of this we are faced with a choice between a compelling description of a withdrawal problem and the data which says no signal. I’m inclined to go with the compelling description. Part of the reason we likely have no signal is that the people affected by problems like this are not doing the reporting; it is doctors who find something like this close to inconceivable who are still the primary reporters of adverse events.

Further supporting research

My inclination on reading FB’s report was to believe her. But more research on RxISK throws up further reasons to go with FB. There is a condition that is usually thought of as rare called thrombotic thrombocytopenic purpura (TTP). In TTP, platelets in the blood form micro-clots (thrombosis) which can cause problems. But the micro-clots also remove platelets from blood which leads to bleeding (purpura). There are 169 reports of TTP on clopidogrel to FDA. This is a whopping signal – PRR = 22.2. (if the PRR is over 2.0, this is taken as evidence of a signal). We don’t know whether these have happened on withdrawal or not – FDA reporting systems don’t make these distinctions. But there is every chance that a significant number have happened on withdrawal. If recoded as part of a withdrawal syndrome, the signal for withdrawal would be much more salient. There is fact a great deal of evidence that stopping clopidogrel is linked to problems. Michael Ho and colleagues in JAMA (2008), 299: 532-539 have shown a doubling of mortality and in particular heart attacks in the 90 days after stopping clopidogrel.

TTP or related problems could readily give rise to just the clinical features FB reports, including anxiety, numbness down her arm, hallucinations and the rest.

RxISK also shows 108 reports of hemorrhagic stroke on clopidogrel. Again the signal for this (PRR = 13.6) suggests strongly that clopidogrel may be causing the problem. These strokes may be TTP related cases. The problem may be happening on the drug or on withdrawal – we just don’t know from the way the data is collected at the moment.

Finally another feature of FB’s case is her reaction to lansoprazole and omeprazole. European regulators have advised against combining clopidogrel with proton pump inhibiting drugs like these. Eliminating acid from the gut likely interferes with a range of different drugs, but in this case PPIs and clopidogrel also interact in the liver, causing FB to slip into withdrawal. If you are a doctor you can put FB’s difficulties down to problems on the drug and not withdrawal but if you do this, then you cannot also say to FB that staying on clopidogrel is risk-free. Who moreover should make the choice as to whether she dies of a heart attack or stroke? FB or her doctor? For many suffering a stroke is close to the ultimate horror.

Staying on the drug is not an easy way-out for other reasons. The risks FB outlines are very real – needing surgery, having the drug discontinued, or accidentally ending up without a supply. But in addition, staying on the drug itself cannot be assumed to be without consequences. We think of drugs like aspirin or the statins as acting simply on platelets or cholesterol levels and as a result wonder where the problem might be in staying on them.

But in fact just as the SSRIs do not work solely or even primarily on brain serotonin levels but even more so on blood system serotonin where just like aspirin they reduce platelet adhesiveness, leading to rebound clotting when stopped and cases of TTP and stroke, so also aspirin and statins can lead to extensive changes through the body that affect the brain and other organs. This can include change of personality, or might lead to other conditions improving or getting worse. We know a great deal about what happens soon after we start taking many drugs but know little about what the longer term effects are, and FB is right to be concerned.

Solutions

It will need great skill to come up an answer. FB may need input from a haematologist rather than a cardiologist. In other cases of withdrawal, I advocate using liquid forms of a drug to wean off very slowly, but Clopidogrel permanently blocks some receptors and so this approach is of no use. She would likely to better stopping Clopidogrel while taking warfarin or a heparin analogue, until her entire supply of platelets have turned over.

FB’s case challenges us to recognize that problems like this may be a manifestation of dependence and withdrawal, and that for instance many aspects of SSRI withdrawal may be intensely physical in origin rather than mental as people sometimes assume. We do not in this case know for instance if the permanent changes Clopidogrel causes in platelets might also happen in brain.

This is a case where patients need a doctor to work closely with them as a team. FB has filled a RxISK report and has taken a copy of this to her doctor. 

Since then

Since this post was made Fiona has been to a haematologist. A range of screening tests have been done. But no-one has been able to pinpoint what is going wrong.

In the Table below, we reproduce the figures from FDA’s adverse event database specifically linked to Symptoms on Stopping rather than for instance stroke or TTP. What this brings out is there are far more things happening on drugs like clopidogrel that are likely linked to withdrawal than are ever reported as withdrawal problems. These are events that are not captured by current systems, and as a result our image of withdrawal is seriously skewed.

One final point to note that in addition to Clopidogrel (Plavix), there are other grels – Prasugrel, and Ticagrelor.  We have not included these here yet, but will update the table in due course/

SoS: Anti-clotting drugs

Earlier this week the Daily Mail  published my feature on side-effects and how patients aren’t properly warned about them. Antidepressants, for instance, can cause compulsive heavy drinking but you wouldn’t know it from the drug information leaflet. 

The article is about campaigning psychiatrist Dr David Healy, who believes patients need a more truthful account of the side effects they risk. It describes his new website – Rxisk.org – that makes it easier to report side-effects and provides a forum where you can swap experiences with other pill users.

Information about side effects is often poor because it gets  hidden by the companies running the trials. A campaign by doctors and journals is now well under way to force drug companies to be more transparent.

Turning garbage into gold

But that’s not enough, according to Healy. He believes there are serious problems with the randomised controlled trial (RCT), the so-called gold standard of evidence based medicine, used to test treatments and decide which ones should be licenced.

Rather than distinguishing safe and effective medical treatments from ones that are dangerous and/or useless, the results from RCTs are frequently misleading and wrong. The RCT, he says, is a processor for turning garbage data into drug company gold.

At first sight his critique appears ridiculous. It is a full-frontal challenge to the whole idea of evidence based medicine. You have to have a way of telling if a drug works and is safe and the RCT has been used for years – since the 1960’s in fact – when it was introduced as a response to the thalidomide disaster.

It works by dividing patients randomly into two groups; one lot gets the drug, the other an inert placebo pill. A few months later the results reveal which group benefited more. Two positive RCTs are needed to get a licence to market a drug.

A serious barrier to treating chronic disease

Healy’s case against RCT’s is not based on bare-faced fiddling of results by the drugs companies, although he’s often exposed it. Even if all trials were squeaky clean they would still be a serious barrier to developing really effective ways of tackling the various lifestyle diseases that are threatening to cripple Western health services.

Take the rule that you only need two RCT’s to get a licence. What about if you also have three negative ones where the drug came out as no better than a placebo? At the moment they simply don’t count. This has everything to do with bureaucratic rules and nothing with scientific rigour. Its an arbitrary rule that deprives doctors and patients of valuable information about what the drug does or, just as importantly, doesn’t do.

But there is more fundamental problem.  Properly conducted RCTs are supposed to tell you if a drug is effective. But what does “effective” mean? The poster boy…

Read more: Daily Mail Online:  Why randomised controlled trials don’t tell you what you want to know

The antipsychotics were the first of the modern psychotropic drugs to be linked to severe withdrawal, but even so few doctors today are aware that there can cause dependence and withdrawal or how bad the problems can be. These drugs are linked to one of the most severe examples of tolerance and dependence leading to a debilitating legacy effect – tardive dyskinesia. My first brush with the fact that dopamine antagonists can cause withdrawal came when Carole came to see me in 1996.

Carole’s Story

In the early 1970s, Carole, a 36 year old woman with no history of mental illness suffered a psychotic breakdown in stressful circumstances that would have led anyone to breakdown. The stress was discounted. She was diagnosed as having a paranoid psychosis, hospitalized for two weeks and treated with Stelazine (trifluoperazine) 10mg tds and an anticholinergic drug. Her Stelazine was reduced on discharged to 5mg tds and after 6 months to 5mg per day. Her doctor, however, having decided she had schizophrenia, decided to keep her on treatment indefinitely.

A return of the illness or something else…?

Despite being on a treatment that would slow her up and demotivate her, she went back to university, got a PhD degree and became a researcher. She complained of lethargy, weight gain and dysphoria and after 16 months when these complaints seemed to be falling on deaf ears, she stopped treatment. But stopping led to nausea, stiffness, pain, headaches and acute anxiety. When she restarted Stelazine, these symptoms cleared up immediately. Her doctor left her with the impression that these were all signs of her illness coming back.

Twenty years later a second effort at withdrawal had the same outcome. A year after this she came to me still on Stelazine and an anticholinergic. I thought stopping her anticholinergic might be a problem. It wasn’t but stopping her Stelazine even by reducing 1mg every two weeks produced stiffness and headaches and then nausea, anxiety, tremor, hyperalgesia – pain on brushing her hair for instance, anxiety especially around her heart, mood instability, a sensitivity to emotional and physical stress, disturbed sleep and concentration.

She was simply not able to get off and stay off treatment. We finally opted to keep her on a low dose of Stemetil – but this anti-nausea agent is really just another antipsychotic.

Held back by the meds

A few years later she developed breast cancer. There was no history of this in the family. But antipsychotic drugs increase breast size and stimulate activity that seems likely to increase the risk of breast cancer. The greatest tragedy was that this was a high-flying woman who ended up living life carrying an enormous weight on her back. She achieved a lot but could have achieved so much more if not held back by her meds. For others the problems can be worse in that the single best way to relieve the dysphoria that antipsychotics cause is red wine and being hooked to these drugs can in this way lead to alcoholism.

In some cases of withdrawal, antipsychotics can trigger a neuroleptic malignant syndrome that can be managed by benzodiazepines. This is particularly likely to be the case if every step down in the withdrawal taper produces very marked anxiety and possible confusion or disorientation. In this case, it is worth trying high doses of benzodiazepines after each step down to smooth the taper.

Symptoms on Stopping - Antipsychotics

The Table below gives some sense of the Symptoms on Stopping these drugs.

A few points to note. Some of these drugs like amisulpiride and sulpiride are available in Europe only and this is why they come up with zero values across the board. Some of the older drugs such as perphenazine shows as having lower withdrawal problems than Zyprexa (olanzapine) or Seroquel (quetiapine). It likely is better than either of these two newer drugs when it comes to withdrawal problems but the main reason they show up as worse is that the data here is based on FDA data from 2004 and perphenazine, trifluoperazine, chlorpromazine and older drugs were being used much less by then.

The Clozapine group of drugs that includes Zyprexa and Seroquel are noted as having some of the worse withdrawal problems. We are missing data on Clozapine at the moment but will add that data and others in due course. Lilly may have received marketing authorization to claim Zyrexa was useful in the maintenance treatment of Bipolar Disorders largely on the basis that it causes withdrawal problems and not stopping leads to an impression it is providing some help in maintaining wellbeing when in fact the drug is the problem that the drug is often treating.

Quite strikingly the relatively recently released Paliperidone (Invega) comes with significant dependence and withdrawal problems. The haloperidol group of drugs of which Paliperidone and Risperidone and Ziprasidone are included all have problems.

The missing data may give the impression that DAAWS is not as common as withdrawal from benzodiazepines, mood stabilizers or antidepressants but it is in fact every bit as bad. In addition to tardive dyskinesia, these drugs produce a well recognized tardive dysthymia and tardive akathisia along with the kinds of stress intolerance, temperature dysregulation and other problems that Carole had.  See the Data Based Medicine Position Paper: Antipsychotics for Takers.

SoS: Antipsychotics

April 30, Dr. Healy will be lecturing at Cardiff University Wales about the role of Psychotropic and Other Drugs in Mass Shootings and Homicides. The following week, Dr. Healy will visit Queen’s University in Kingston, Ontario, Canada, to debate the future of psychiatry, and to give a lecture entitled “How Regulating Drugs has Killed the Art of Medicine”.

May 22, Dr. Healy will arrive in San Francisco, for a debate at the American Psychiatric Association Annual meeting on the efficacy of Antidepressants in Major Depressive Disorder.

Next, Dr. Healy will return to the UK to participate in a panel discussion entitled “Are Doctors Bad For US?” on Sunday May 26 at the HowTheLightGetsIn2013 festival at Hay.

In the debates and lectures, Healy will refer to RxISK.org which he sees as a solution to the problems created by Evidence Based Medicine and flawed Random Controlled Trials. RxISK.org, masterminded by Dr. Healy and several close colleagues. RxISK is a project which aims to improve prescription safety through the systematic collection of information about consumer experience. RxISK.org is the first free, independent website where consumers can report their own experience of prescription drug side effects, and receive personalized assessments of the risk that their prescriptions are causing the problems they report.

About Data Based Medicine Americas Ltd.

RxISK.org is owned and operated by Data Based Medicine Americas Ltd. (DBM), based in Toronto, Canada. DBM’s founders have international reputations in early drug-side-effect detection and risk mitigation, pharmacovigilance, and patient-centered care. Although drug side effects are known to be a leading cause of death and disability, less than 5% of serious drug side effects are reported. DBM’s mission is to capture this missing data directly from patients through RxISK.org’s free drug side effect reporting tool and use this data to help make medicines safer for all of us.

Media contact
David Carmichael
david(dot)carmichael(at)RxISK(dot)org
+1 (647) 799-3792

Venues

2013-05-26
Hay-on-Wye
The Institute of Art and Ideas How The Light Gets In 2013, the world’s first philosophy and music festival
Are doctors bad for us? Panel discussion (4-6pm)

2013-05-22
San Fransisco, California
American Psychiatric Association,
San Francisco Convention Center, Moscone South – Esplanade Level – Room 302
Antidepressants in Major Depressive Disorder: The Efficacy Debate
(2-5pm)

2013-05-10
Kingston, Ontario
Johnson Auditorium, Hotel Dieu Hospital
How Regulating Drugs has Killed the Art of Medicine.
(12:15-1pm)

2013-05-10
Kingston, Ontario
Johnson Auditorium, Hotel Dieu Hospital
Psychiatry Debate. The proposition is this: “This House Believes that the speciality of Psychiatry is going to become less important”
(11am-12pm)

2013-04-30
Wales, UK Cardiff University: Stanley Parris Lecture Theatre in Psychology Department
Mass Shootings and Homicide on Psychotropic and Other Drugs
(11am-12pm)

I was prescribed Mirapex (Pramipexole), a ‘Dopamine Agonist’, in early 2012 for ‘Restless Legs Syndrome’. I took it for around 4-5 months but eventually decided to stop because it wasn’t working. I cut the dose down gradually and stopped altogether in September 2012. I must add that I suffer with Crohn’s disease and Type 1 Diabetes.

I went through a clear physical withdrawal which lasted a few days but then following this something else started. The symptoms were feeling like I had ‘flu, yawning, trouble sleeping, and total lack of energy. This lasted a few days. When this stopped, I was left with an overwhelming depression. The depression has lasted to this day with only occasional relief. On the few days I have had relief, I have felt perfectly normal and able to carry out my usual tasks but this is followed by another relapse and all the symptoms re-appear.

It’s as if I have no control over my own body

The depression has not lifted (apart from the odd day) since I came off the drug. This is NOT a natural depression. I have had a slight tendency to get depressed all my life but this is like nothing I have ever felt before. It is as if my body is controlling itself and I have no control over it.

I was 99% certain Mirapex caused this and then in my investigations into ‘Dopamine Agonists’ I came across a condition known as ‘DAWS’ – Dopamine Agonist Withdrawal Syndrome’. This is apparently where following withdrawal of dopamine agonist drugs, like Mirapex, the brain doesn’t re-start producing its own dopamine. The main symptoms of DAWS are anxiety, panic attacks, depression, agitation, irritability, dysphoria, insomnia, and fatigue.

With me, it is the depression that has hit the hardest. It will not subside. I have no control over it. I have been shown many techniques for controlling depression and for a normal depressed person, these would work in most cases but, with DAWS, there is NOTHING at all that will stop it apart from going back on the drug. This I will not do unless I have been permanently damaged by this drug. I am beginning to wonder if this is the case.

I have coped with Crohn’s disease and Diabetes pretty well and, most of the time these don’t get me down. I just accept them and control the conditions as best I can. I have had Crohn’s for 36 years and Diabetes for 27 years and, at no time have I got particularly depressed over these diseases.

Unbearable depression & feeling suicidal

In the week of 16^th– 23^rd Feb the depression became unbearable and by the time Friday came, I was suicidal. I called The Samaritans who kindly listened and agreed to phone me back the next morning as I had told them I wanted to die. I didn’t feel much better the next day, very tearful but, took the call and just spoke about how I was feeling.

I have made many attempts to help myself through this including getting in touch with old friends and arranging a meet up with an old girlfriend. Unfortunately this did nothing to lift my mood. I have been doing voluntary work and have quite a few opportunities to mix with people so it isn’t lack of company that is causing the depression.

While the depression is at its worst, I cannot stop myself crying and this happens anywhere and at any time. This has been the most brutal experience I have been through in my entire life and shows absolutely no sign of ending. I refuse to take antidepressants as they have not been proven to have any benefit for DAWS and I have no wish to become addicted to another drug

All in all, my ongoing experience with DAWS has been the most brutal, demoralising, relentless, life endangering experience I have ever known. Most days I want to end my life just to escape it. Because I cannot seem to find proper information on how long it is supposed to last, I find myself running out of hope.

Please share a similar experience

I would like to find other people who have been through DAWS and survived! There is very little information on how long it lasts. The only information is about the symptoms. The nearest I have come to finding a similar situation is on a forum called ‘Social anxiety support’ in which the person describes his attempt to come off Mirapex. It is worth taking a look because it confirms how difficult this can be.

If there IS anyone out there who has been through a similar situation, I would be grateful to hear from you.

Data on DAWS

The table below fully bears out Renny’s view of DAWS. Dopamine agonists which are used for Parkinson’s disease, Restless Legs Syndrome and other problems are very similar in their mode of action to stimulants like methamphetamine and dexamphetamine. They case a range of addictive behaviors from sex addiction to compulsive gambling (See Addicted to Sex). The table below shows reports of abuse and addiction consistent with this, but it also shows Symptoms on Stopping as in Renny’s case.  No-one knows, as she outlines, how long this goes on for or what steps can be taken to make a difference. All reports would be very welcome to both her and us.

SoS: Dopamine Agonist Withdrawal Syndromes

But a few, very few, actually manage to do all of the above…and more.

It is a great honor to be able to interview one such individual who will, for many readers, need no introduction at all. Dr. David Healy is an internationally respected psychiatrist, psychopharmacologist, scientist, and author. A professor of Psychiatry in Wales and former Secretary of the British Association for Psychopharmacology he has written numerous peer-reviewed papers, articles and is the author of 20 books, including his latest entitled Pharmageddon.

David is also one of the founding leaders associated with the www.RxISK.org website, a “free, independent website where patients, doctors, and pharmacists can research prescription drugs and easily report a drug side effect — identifying problems and possible solutions earlier than is currently happening.“ He is, as we say, a 10 talent man.

It is an extraordinary privilege and honor to have David answer a few questions about his work for us here at The Honest Apothecary. He is an advocate for patients, and is very supportive of the role of pharmacists to educate patients about their medications. I do hope you enjoy listening in.

Read the full interview: The Honest Apothecary: Pharmageddon, RxISK.org, and an interview with Dr. David Healy