How many people suffered adverse reactions to Clozapine in 2011?

name removed 23 Oct 2012 (Account suspended) made this Freedom of Information request to Department of Health and Social Care

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was refused by Department of Health and Social Care.

name removed 23 Oct 2012 (Account suspended)

Dear Department of Health,

I am making enquiry of the National Programme of Clozapine administration.

1. Please may I enquire how many drug companies are involved? And their names?

2. How many registered pharmacists are currently involved in the national Clozapine programme?

3. How many registered Responsible Clinicians are currently involved in the national Clozapine programme?

4. How many registered clinicians are currently involved in the national Clozapine programme?

5. How many patients in 2011 were registered into the national Clozapine programme?

6. How many patients were removed from the Clozapine programme because of a pre-existing heart condition of sinus tachycardia and right atrial enlargement?

7. How many patients with a pre-existing heart condition of sinus tachycardia and right atrial enlargement were continued with Clozapine anyway?

8. Can Clozapine worsen a pre-existing condition of sinus tachycardia and right heart enlargement [as discovered on ECG] and if so, should Clozapine NOT be given to such a patient who is KNOWN to have such a condition?

9. How many patients with a pre-existing heart condition of sinus tachycardia and right atrial enlargement were removed from the programme because the drug company involved were worried that their drug might WORSEN the pre-existing condition?

10. How many patients with a pre-existing heart condition of sinus tachycardia and right atrial enlargement were continued with the programme because the clinician decided that as it was a pre-existing condition it did not matter? And if so, were they proved correct?

11. How safe is Clozapine for patients with any heart condition of tachycardia in any respect?

12. Does the use of Bisoprolol make it possible to continue with Clozapine in the reference of sinus tachycardia and right atrial enlargement, which reduces the heartbeat but can also lead to hypotension? What is the critical balance? Where is the line drawn that Clozapine and Bisoprolol might be giving more disbenefit than benefit?

13. How does the Department of Health warn the clinicians, pharmacists and drug companies about how to prescribe Clozapine in patients who have sinus tachycardia and right atrial enlargement?

14. Is there any safe dose of Clozapine that can be given long-term to patients who have sinus tachycardia and right atrial enlargement that will not lead to a worsening of their heart condition? And if so, what is it? Or are the risks of Clozapine over a long period outweighing the perceived benefits of Clozapine in the longer term?

15. I am well aware that Clozapine in the right circumstances has proved efficacious according to medical literature, and my request is simply to find out what safe dosage can be given to someone who has sinus tachycardia and right atrial enlargement. Is it contraindicated?

Thank you very much for your kind help.

If this is not something the Department of Health can address, please pass it on to the correct authority who CAN help me. I have come to you in the first instance as you are the Government, but if an alternative authority is the one that can answer these questions, I would be most grateful, please, if you can forward it to the relevant Department or Authority.

It could be most helpful to people wishing to know about their heart condition and drug use.

Thank you very much,

Yours sincerely,

[first name removed] [last name removed]

Department of Health and Social Care

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Department of Health website’s [4]Frequently Asked Questions. 

Please note that the Department of Health does not process complaints
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17 January 2012
 
Our ref: DE00000669241
 
Dear Ms [last name removed],
 
Thank you for your email of 29 December making a request under the Freedom
of Information Act (2000) for information about the drug clozapine. 
 
The Department of Health does not hold any information relating to your
request. 
 
The Medicines and Healthcare products Regulatory Agency (MHRA) is the
Government agency that is responsible for ensuring that medicines and
medical devices work and are acceptably safe, and may hold information
relating to your request.  You may wish to contact them directly at:
 
MHRA
151 Buckingham Palace Road
Victoria
London SW1W 9SZ
 
Website: [1]http://www.mhra.gov.uk/  
 
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submitted within two months of the date of receipt of the response to your
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Head of the Freedom of Information Team
Department of Health
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Richmond House
79 Whitehall
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Email: [3][email address]   
 
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Yours sincerely,
 
Jane Ivey
 
Freedom of Information Officer
Department of Health
 

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name removed 23 Oct 2012 (Account suspended)

Dear Ms Ivey,Department of Health,

Thank you for your response and I will make my FOI to the MHRA and explain that you have referred to them.

Yours sincerely,

[first name removed] [last name removed]

name removed 23 Oct 2012 (Account suspended)

Dear Department of Health,

Please pass this on to the person who conducts Freedom of Information reviews.

I am writing to request an internal review of Department of Health's handling of my FOI request 'How many people suffered adverse reactions to Clozapine in 2011?'.

I am grateful to you for suggesting that I take my FOI in the alternative to MHRA, but I wish to request an Internal Review, nonetheless, for maybe you now do have information - even if it is only in draft form, because if the MHRA have it, or some observatory, do they not give it to the DH?

Otherwise how can the Secretary of State for Health be kept informed?

I am very concerned about the recent report of a Coroner's Decision which specifically referred to Clozapine - re Catherine Bell.

So, even if you do not have ALL the people affected by Clozapine, may I request what information you DO have on the adverse effects of Clozapine and how many people the DH has hitherto been informed about as having died from Clozapine or died where Clozapine was implicated?

If the DH do not have a "rolling figure" on such information, I believe that it should make it a priority immediately to do so, for people's lives are potentially at risk.

The MHRA have informed me via FOI Request that the National Clozaril Programme DOES NOT include Heart Monitoring via the Responsible Clinicians, Pharmacists and Drug Companies -- it ONLY checks for agranulocytosis.

Yet it was the HEART effects that so worried me, such as Right Atrial Enlargement and regular pattern of Sinus Tachycardia as found on ECG, and therefore asked them if they could re-assess their priorities.

And I wish to ask the DH likewise to investigate the HEART safety of Clozapine and insist that when the blood tests are checked they check for dyscrasias not just agranulocytosis, and also with the same timeframe as checking the bloods, to conduct ECGs, so that a patient and their families and carers can check for any "silent" heart disease or condition occurring, for Clozapine is known to affect the heart as a side-effect and patients need a "black box" warning on their medication box and PIL to warn them of such dangers, and what specifically to look out for.
=====================================================

PILS OF PRESCRIPTION DRUGS:
I read with much concern that the PILs of Prescription Drugs might not have to be compulsory in future where it is for a group of people such as in a hospital, for example - this would be extremely unwise as how will the practitioners giving out ANY drugs [not just Clozapine] KNOW what side-effects to check? After all, there are literally thousands of drugs approved by NICE and nobody can have perfect knowledge without the full PILS available rather than a shortened form.

I speak here of AVANDIA as a prime example of which I have personal knowledge and the devastating effect of NOT having a fully comprehensive knowledge of the FULL details of Avandia until I requested it from the drug company, but only after a person had died from being given a drug "off label" which is currently being investigated by a Fitness to Practise panel of the GMC, of which I have made you aware, but which the GMC say is still ongoing [as of Christmastime 2011]. I contacted GSK and said that I believed that people should have had a "black box" on Avandia, but crucially did not blame GSK for Avandia, as their PILs specifically stated that it should not be taken by people with Heart Failure or history of heart failure. Thus, the DH, in my opinion, should look very carefully indeed at both Clozapine / Clozaril prescriptions and the very careful comprehensive monitoring to be compulsory with the details of the heart monitoring to be given to the clinician, pharmacist and drug company WITHIN the Clozaril Monitoring Program.

Thank you.

I look forward to having your internal review, and response to my views,

Yours sincerely,

[first name removed] [last name removed]

Campaigner for Liberty, Truth and Justice

A full history of my FOI request and all correspondence is available on the Internet at this address:
http://www.whatdotheyknow.com/request/ho...

name removed 23 Oct 2012 (Account suspended)

15 FEBRUARY 2012

Dear Mr Cameron Prime Minister of Great Britain and Northern Ireland, Mr Lansley Secretary of State for Health, Lord Howe Parliamentary Under-Secretary for Quality at the Department of Health,Mr Turner MP for the Isle of Wight,

I am writing to request what you now know regarding the safety of Clozapine and Amisulpride in light of what the MHRA has given to me as a result of the DH sending me to the MHRA for information.

For I now have very disturbing details of significant -and some fatal - reported side-effects of both Amisulpride and the VERY toxic Clozapine.

In the light of these NEWLY-PUBLISHED results, what is now the stated position of the Department of Health where it was recorded by the MHRA that 515 fatalities were REPORTED to the MHRA as being linked to Clozapine in the 12 months of 2011.

To me this is of epidemic proportions.

I knew of ONE specific fatality where the Coroner had reported in his Decision of December 2011 regarding Catherine Bell that her death was definitely linked to Clozapine.

But now I read that there were many others reported to the MHRA.

So what EXACTLY is the status of this toxic substance? I have tried various agencies most of which state they have no knowledge. Please see my FOI Requests on http://whatdotheyknow.com for information.

If the Prime Minister and Secretary of State and DH are unaware of what is going on in the country where they run the NHS, what hope the rest of us to be able to apprise the safety of drugs?

This is like a re-run of a "Yes, Minister" and/or "Yes, Prime Minister" sitcom where nobody really knows what is going on because it is all divided into little pockets of information and nobody, least of all the ministers, actually know what is going on with the overall picture.

This is not a blame game - but a reality - a fact of life as epitomised in the TV series of that name.

But here, unfortunately, the laughs are the "danse macabre" of a system totally in need of transformation so that patient safety is at the heart of all the NHS.

I wish there to be a NATIONAL MORATORIUM on the safety of ALL antipsychotics.

Clozapine is so dangerous that I believe it stands out amongst all the rest - but there are other dangerous concoctions such as Amisulpride which was also reported to the the MHRA as causing deaths - far fewer than Clozapine but deaths nonetheless - and that is an individual tragedy for each and every family who loses a member of their family.

This was of a total reports numbering over 300 of adverse effects pertaining to Amisulpride to the MHRA. Parkinsonism was one of these. Weight loss another. Heart problems another.

Please may I know if there is indeed to be a NATIONAL DEBATE ON MENTAL HEALTH AND ANTIPSYCHOTIC USE WITH THE PUBLIC - NOT JUST INTERESTED PROFESSIONALS? I believe so strongly that people are being medicated against their will in the Mental Health System where people can be FORCED to take drugs they do not wish to have under antiquated and outmoded legislation that belongs more to the times of Dickens and the Artful Dodger than 21st Century democracy of the United Kingdom, I aver.

I look forward to receiving the Internal Review that I have requested already.

Thank you very much,

Yours sincerely,

[first name removed] [last name removed]

Department of Health and Social Care

Thank you for contacting the Department of Health.
This is an acknowledgement - please do not reply to this email.
Where a reply is appropriate, we aim to send one within 18 working days or
20 working days if your query is a Freedom of Information request.
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response may have been published.

If your enquiry is about a medical matter, please contact NHS Direct on
0845 4647 or visit [2]NHS Choices, or contact your GP surgery.

For general health information you may also find it helpful to refer to
[3]Directgov, the UK Government’s Official information website, or the
Department of Health website’s [4]Frequently Asked Questions. 

Please note that the Department of Health does not process complaints
about the NHS or social services. If you wish to make a complaint about a
healthcare professional, an NHS organisation or a social care provider,
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1 Attachment

Dear Mrs [last name removed],

Please find attached our reply to your request for an internal review of
FOI case 669241.

(See attached file: 669241R Reply [last name removed].pdf)

Yours sincerely,
Lynwen Paddy
Senior FOI Manager
Freedom of Information Team
Email: [1][email address]
 

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name removed 23 Oct 2012 (Account suspended)

22 February 2012

Dear Ms Lynwen, Department of Health,

Thank you very much for explaining this to me - so in effect your Arm's Length body is part of the DH and therefore you do have this information at the MHRA?

I was confused. Are there any other arm's length bodies of the DH? Please may I ask what they are and what their purpose is.

Since 2006, I have been contacting the Department of Health and I would be most grateful if I may be given my data under the DPA1998 since 2006 to the present day.

I remember writing to Mr Agarwal in 2007 and would like to know if he is still at the DH as I am seeking email correspondence between me and the DH, and maybe if you have any information you have stored about me, I would be most grateful to receive. My computer crashed and so I cannot access these.

Thank you so much,

Yours sincerely,

[first name removed] [last name removed]

Department of Health and Social Care

Thank you for contacting the Department of Health.
This is an acknowledgement - please do not reply to this email.
Where a reply is appropriate, we aim to send one within 18 working days or
20 working days if your query is a Freedom of Information request.
If you have contacted the Department of Health about a current health or
social care campaign, please visit the [1]Department's website where a
response may have been published.

If your enquiry is about a medical matter, please contact NHS Direct on
0845 4647 or visit [2]NHS Choices, or contact your GP surgery.

For general health information you may also find it helpful to refer to
[3]Directgov, the UK Government’s Official information website, or the
Department of Health website’s [4]Frequently Asked Questions. 

Please note that the Department of Health does not process complaints
about the NHS or social services. If you wish to make a complaint about a
healthcare professional, an NHS organisation or a social care provider,
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2 Attachments

Dear Mrs [last name removed],

Thank you for your request for your personal data. I attach a letter
explaining what further information is required from you in order for us
to complete a search for  this.

(See attached file: Initial letter_VFr_20120223.pdf) (See attached file:
DP SAR_ dhweb_20120223.pdf)

Please be aware that the Department of Health has a retention/disposal
policy covering all types of documentation including correspondence.

Yours sincerely,

Veronica Fraser
Head of Data Protection, Information Risk Management and CHIP Briefing
System
Information Assurance and Departmental Security
Information Services
Direct Line: 020 7972 1754
GTN Tel: 396 21754

Email: [email address]
Address: Department of Health | Room 334B Skipton House | 80 London Road |
London SE1 6LH
 
 
P Check out the new IT help section on Delphi. Your one stop shop for all
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name removed 23 Oct 2012 (Account suspended)

Dear Ms Fraser,Department of Health,

Thank you very much for your kind help,

Yours sincerely,

[first name removed] [last name removed]

name removed 23 Oct 2012 (Account suspended) left an annotation ()

It may be useful to know that the Department of Health does not per se hold information on Clozapine but that its arm's length body the MHRA does hold this information.

Department of Health and Social Care

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name removed 23 Oct 2012 (Account suspended)

1 MARCH 2012

Dear Ms Basan Department of Health, Mr Lansley Secretary of State for Health, Earl Howe Parliamentary Under Secretary to the Department of Health and Mr Turner MP for the Isle of Wight,

I am very grateful to you, Ms Basan, for your detailed response to my request for information.

I am now very concerned about just how the MHRA and the Department of Health determine just HOW safe a drug is, for if the DAPs are not to be relied upon as being the FACTUAL evidence but only possibly "coincidental", then this really does beg a national moratorium on how drugs are FULLY checked for their efficacy and safety.

I note that it is claimed that Clozapine can bring about fatalities.

HOW MANY FATALITIES HAVE BEEN ASSOCIATED WITH CLOZAPINE AND HOW MANY WITH AMISULPRIDE?

I cannot understand why the Toxicbase cannot be made available to the general public - I am unconvinced by any argument that it might be dangerous.

I find it more dangerous to read of a person who died not long after being given Clozapine in 2011 - namely Catherine Bell whose Coroner's Decision was published and now is on the internet for anyone to read worldwide.

"Officials have confirmed that the information provided to you by the Medicines and Healthcare products Regulatory Agency (MHRA), the Drug Analysis Prints (DAPs) for clozapine and amisulpride, is not newly published information. DAPs for all medicines authorised for use in the UK are published on the MHRA’s website for all to view, and are regularly updated. DAPs provide a listing of all UK cases of suspected side-effects reported to the MHRA.

As the MHRA stated when it provided this information to you in response to your Freedom of Information request (MHRA enquiry reference number: FOI 12/024), the reporting of a suspected adverse drug reaction does not necessarily mean that drug in question caused the reported adverse events. Importantly, a DAP cannot and should not be used as a list of proven side-effects of the drug to which it refers. Further detailed review of the reported cases by doctors and scientists at MHRA is required to determine whether the reported suspected side-effects could in fact be real side-effects. Many things have to be taken into consideration when assessing whether or not a drug could have caused any symptoms which occur after taking the drug. These include time to onset of the symptoms, the illness that the drug is being used to treat, and any other illnesses from that the patient suffers. It is also quite possible that symptoms experienced after taking a drug are purely coincidental and would have occurred whether the patient took the drug or not. It is therefore important that DAPs are interpreted appropriately and readers should refer to the guidance notes that are provided with DAPs.

I note your particular concern regarding the safety of the antipsychotic clozapine after the death of a woman taking clozapine had been attributed to the drug by the Coroner for the case. Unfortunately, all effective medicines have side-effects and clozapine is no exception. Therefore, the benefits of treatment with any medicine need to be weighed against the known side-effects.

Clozapine can cause some serious and potentially life-threatening side-effects, which are not caused by other antipsychotics. These include agranulocytosis (severe and dangerous reduction in the number of white blood cells which leaves the patient prone to, and unable to fight, infections), myocarditis (inflammation of the heart muscle), cardiomyopathy (a condition that causes the heart muscle to be abnormally enlarged, thickened or stiff), and paralytic ileus (obstruction of the intestine due to paralysis of the intestinal muscles). However, due to the known risks associated with clozapine, its use is subject to a number of restrictions that are stipulated in the licence and are intended to minimise the risk from the known side-effects.

The use of clozapine is restricted to treatment-resistant schizophrenia (treatment resistance is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two different antipsychotic agents, including an atypical antipsychotic agent, prescribed for adequate duration) and for patients who have experienced severe and untreatable neurological adverse effects to other antipsychotics. It is also licensed for the treatment of psychotic disorders in Parkinson’s disease, but again, only in cases where standard treatment has failed. This means that all patients with schizophrenia or Parkinson’s disease are not routinely and unnecessarily exposed to the risks associated with its use, and that clozapine is available only for patients who require an alternative to other available medicines.

In addition, all patients who take clozapine must be registered with a patient monitoring service in which regular blood testing is mandatory. This measure is in place to reduce the risk from agranulocytosis specifically. The incidence of agranulocytosis and the fatality rate in those developing agranulocytosis have decreased since the introduction of mandatory blood count monitoring.

The clozapine product information for healthcare professionals and patients or carers contains extensive warnings about the known side effects of clozapine. Furthermore, the prescribing information clearly states that fatalities have occurred as a result of some of the side-effects of clozapine, emphasizing the need for a careful evaluation of the benefits and risks of treatment before a prescriber starts any patient on clozapine.

Clozapine has significant advantages over other available antipsychotic medication; it has been shown to be effective in patients who have failed to respond to other antipsychotic medication and can reduce the risk of suicide in patients with schizophrenia over and above other antipsychotics. It is also important to remember that whilst clozapine is known to have serious side-effects, these effects are rare and not every patient who takes the medicine will develop these side-effects. Providing that clozapine is used in accordance with its licence and the restrictions on its use are adhered to, it remains an important medicine in the treatment of severe mental illness in the UK in spite of the known risks associated with its use.

The safety of all antipsychotics, including clozapine, continues to be monitored closely by the MHRA.

I hope this reply is helpful.

Yours sincerely,

Priya Bassan
Customer Service Centre
Department of Health"

Please tell me what data you have regarding Coroners' Decisions about antipsychotics in the UK and especially Amisulpride and Clozapine.

Thank you very much for your help, and I ask for a moratorium on how drugs are fully tested for their side-effects. Are people being clinically trialled without their knowledge or consent?

As many people are on a Section 3 who are prescribed antipsychotics without their consent, it really means that the Secretary of State has taken over their free will and habeas corpus no longer applies.

In such a situation, how can a Nearest Relative make complaint? And if the Nearest Relative who has complained is then dismissed, how can the person who has been DAMAGED by the administration of such dangerous drugs - without their consent - get redress?

Thank you so much,

Yours sincerely,

[first name removed] [last name removed]

Campaigner for legal reform, liberty, truth and justice

Department of Health and Social Care

Thank you for contacting the Department of Health.
This is an acknowledgement - please do not reply to this email.
Where a reply is appropriate, we aim to send one within 18 working days or
20 working days if your query is a Freedom of Information request.
If you have contacted the Department of Health about a current health or
social care campaign, please visit the [1]Department's website where a
response may have been published.

If your enquiry is about a medical matter, please contact NHS Direct on
0845 4647 or visit [2]NHS Choices, or contact your GP surgery.

For general health information you may also find it helpful to refer to
[3]Directgov, the UK Government’s Official information website, or the
Department of Health website’s [4]Frequently Asked Questions. 
Please note that the Department of Health does not process complaints
about the NHS or social services. If you wish to make a complaint about a
healthcare professional, an NHS organisation or a social care provider,
please visit the '[5]Making a complaint' page on the Department's website.
 
You can find out more about the Department’s commitments from our
[6]Customer Charter and [7]Information Charter.

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name removed 23 Oct 2012 (Account suspended)

23 March 2012

Dear Ms Dade, Department of Health, Mr Lansley Secretary of State for Health, Lord Howe Parliamentary Under Secretary of State to the Department of Health, Mr Turner MP for the Isle of Wight, MHRA,

Thank you very much for the information provided regarding clozapine, your ref: DE00000685117

I refer specifically to the text of this response:

"By law, before a medicine can be placed on the market, it must be given a marketing authorisation (product licence) by a medicines regulator; in the UK this is the Medicines and Healthcare products Regulatory Agency (MHRA). Before granting a licence the MHRA needs to know whether the medicines works well with minimal harm for most people who will be taking it, and is acceptably safe. Every medicine has side-effects, ranging from minor to severe and it is important to consider the risks associated with the use of a medicine in the context of the benefits of treatment with that medicine."

MY SUPPLEMENTARY QUESTIONS IN RELATION TO THIS REPONSE:

1] When did the MHRA itself check Clozapine before granting a licence?

2] Which trials were conducted to prove that Clozapine is safe for
a] human consumption?
b] injection into a human?

3] Did the MHRA concert their efforts worldwide with other agencies to find out how safe Clozapine is? I understand that Clozapine was banned from use in certain parts of the world. When was this? Has it ever been banned in the UK? If so, when?

=======================================================

The DH response continues:

"During the licensing of all medicines including antipsychotics, a specially trained panel of medicines assessors reviews all the available evidence arising out of the pre-clinical research and clinical trials. Only when the MHRA is satisfied that a medicine meets high standards of safety, quality and that it works for the purpose intended, will the licence be granted."

MY SUPPLEMENTARY QUESTIONS:
Has the MHRA been apprised of CDN Isotopes of February 2012 wherein there is specific reference to Clozapine being a KNOWN CARCINOGEN?

If not, why not? And if so, where is there any confirmation by the DH and MHRA and HPA and HSE and NICE that they are all investigating this as a potential disaster drug such as happened with Thalidomide or with the "mattress grade" silicon breast implants?

------------------------------------------------------

The DH continues:

"However, it is recognised that it is impossible to know about all the side effects and benefits of a medicine when it is first licensed. Different people react to the same medicine differently and some rare and unexpected side effects may only emerge after a medicine has been in use for several years. The MHRA continues to monitor the benefit-risk balance of a medicine after licensing and throughout its life – a process called pharmacovigilance."

MY SUPPLEMENTARY QUESTIONS:
I note that in around 2009 there was much debate about the actual safety of Clozapine in any event. Have the DH and MHRA and NICE and HPA and Secretary of State for Health now taken a stance regarding whether or not we shall be entitled to have a national moratorium on the safety of drugs prescribed for mental health in toto?

I believe it should be agreed that we should have a formal debate.

======================================================
The DH continues:

"As my colleague stated in her previous reply (our ref: DE00000680974), the Yellow Card scheme is the UK national reporting system for suspected side effects to medicines, and is run by MHRA. Reporters are asked to report suspected side effects, whether or not they are certain that a certain medicine caused the symptoms. Once a report is received by MHRA, a team of doctors, pharmacists and drug safety scientists carefully assesses the information provided to try to determine whether the symptoms were possibly caused by the drug in question. Many factors have to be taken into consideration during this assessment.

You ask how many fatalities have been associated with clozapine and amisulpride. Since July 1963, the MHRA has received a total of 2,290 spotaneous adverse drug reaction reports for clozapine that reported a fatal outcome, and 56 spontaneous adverse drug reaction reports for amisulpride that reported a fatal outcome.

The Yellow Card scheme is just one way in which the MHRA monitors the safety of medicines post-licensing in the UK. The MHRA also uses information from a number of different sources to ensure that all relevant information about a particular suspected side effect is reviewed. This includes information provided by the pharmaceutical industry, the published medical literature and information from other drug regulators world-wide."

MY SUPPLEMENTARY QUESTIONS:
If Amisulpride and Clozapine together have been stated to be involved in 2,290 adverse reactions reported to have a fatal outcome, how many Coroners' Decisions have there been where Amisulpride OR Clozapine have been specifically linked with death?

I ask this because it has been advanced to me that as NICE and MHRA approve the use of both Amisulpride and Clozapine therefore they MUST be safe to use.

Is this actually an over-simplification of the real politik?

Because if I am to understand you correctly, you do NOT state categorically that either of these drugs has a GOOD SAFETY RECORD, do you? Indeed you state that all drugs have side-effects.

But in order for patients and their Responsible Clinicians [in the case of Clozapine] and their Responsible Pharmacists [in the case of Clozapine] to get ample and optimal information on the side-effects of Clozapine, how many UNTOWARD incidents have been reported either by clinicians or by patients or their friends or family regarding Clozapine in any event since your records began?

=====================================================

The DH continues:

"As you are aware, antipsychotics are used to treat severe mental illness including schizophrenia and other psychoses, and bipolar disorder. These are chronic and extremely disabling illnesses. Patients with schizophrenia or bipolar disorder may experience symptoms such as delusions, decreased inhibitions, risky behaviours, depression and preoccupation with death (bipolar disorder) or delusions, hallucinations, and depressive symptoms (schizophrenia).

These symptoms may have a significant impact on an individual's ability to function day-to-day, live independently, and to maintain relationships and hold down a job. Untreated severe mental illnesses can be fatal. Research suggests that an estimated 25-50 percent of people with bipolar disorder attempt suicide at least once and completed suicide occurs in 10-15 percent of individuals with bipolar I disorder. For people with schizophrenia, 20-40 percent will attempt suicide at least once.

Antipsychotics, in-spite of their limitations, play an important role in relieving symptoms and reducing the risk of relapse, helping individuals to maintain an improved quality of life. The balance of benefits and risks for all antipsychotics currently licensed in the UK is positive in the licensed indications."

MY SUPPLEMENTARY QUESTIONS:
Does the DH carry out surveys of patients and their families where Clozapine is being "trialled"? I am concerned that Clozapine has been described by CDN Isotopes in a document in February 2012 as being a KNOWN CARCINOGEN.

Is there actually any excuse for a known carcinogen to be given to ANYBODY?
======================================================

DH continues:

"If you have any further queries about medicine safety you should to contact the MHRA directly. The contact details are available at http://www.mhra.gov.uk/Contactus/index.htm.

All organisations delivering NHS care recognise that they owe a duty of care to any patient they treat and that because of this, issues and concerns are best resolved by the local organisation or organisations concerned. If a patient or relative of a patient is concerned about the medicine prescribed to them, they should discuss this directly with the prescriber. If they remain concerned, they should contact the primary care trust (PCT) responsible for commissioning care in the patient's area. A list of PCTs is available at http://www.nhs.uk/ServiceDirectories/Pag...

MY SUPPLEMENTARY QUESTIONS
Now that Primary Care Trusts are being demolished who is to be contacted with concerns, especially where the Commissioning PCT denies any responsibility for any medication in any event? This is a concern to me as I have had PREVIOUS complaint about ROSIGLITAZONE AND AVANDIA being given to my deceased mother, yet the Bromley Primary Care Trust NEVER identified that they were in any way responsible for allowing off-label prescription of drugs. What was the position in 2006 please?

Thank you very much indeed for your help,

Yours sincerely,

[first name removed] [last name removed]

Campaigner for legal reform, liberty, truth and justice

Department of Health and Social Care

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