Victims of pharmaceutical harm line up with posters demanding better medicine regulation from MHRA
Victims of pharmaceutical harm line up with posters demanding better medicine regulation from MHRA

Campaign events

All Trials Registered

8th February 2016

Valproate toolkit launch

Over the last year Charities, campaign groups, professional bodies and the MHRA have worked together to develop information to raise awareness of Valproate risk.


3rd February 2016

Local Offer Live, Leicester

#FACSaware, OACS charity and MHRA Yellow Card join together to promote Yellow Card and Valproate risk.


29th January 2016

Stakeholder engagement meeting at MHRA


8th January 2016

Stakeholder engagement meeting at MHRA


Summary of 2015 action

FACSaware and OACS charity worked together with the MHRA and Department of Health to develop new guidelines and information about Valproate.


NHS Choices information 
The DoH Social care blog 
drug safety update 
Black Triangle 
A dear doctor letter.  
Patient Information 
Healthcare professional information  
Patient Information Leaflet 
Consent forms  



21st November 2014

CMDh endorse EMA PRAC recommendations


13th November 2014

FACSaware and OACS attend Department of Health

The meeting was to discuss what information needs to be given to Patients, by who and in what format.


27th June 2014

Patient participation at EMA.

#FACSaware campaigners from UK will be participating in the European Medicine Agency review into Sodium Valproate.  French and Belgian campaigners will also be attending.


18th June 2014

Meeting in Parliament

Alec Shelbrooke MP, Chair of the APPG Thalidomide and other harmful drugs prescribed during pregnancy, has added Sodium Valproate birth defects to the APPG.  This meeting plans to formulate a workable strategy to raise awareness of FACS.  #FACSaware campaigners will be participating.



20th May 2014

International Clinical Trials Day

'This has to be the last International Clinical Trials Day of the era when trial results are withheld'

Ian Bushfield,

Sense about Science

View the AllTrials video


April 2014

MHRA update Yellow Card and issue further guidance.

Many thanks to the MHRA.


19th November 2013

MHRA issue Drug Safety Updates about Epilim.

We have made a difference. 

#facsaware would like to thank everyone who has contributed.


18th November 2013

Sodium Valproate - The Cost. 

Preview of film at the London College of Communication.

View the Trailer

View the Film.

The film is a critique of the UK legal system and the cost of Sodium Valproate to the Taxpayer. 

4 Mothers and 2 children attended the preview.


11th November 2013

Alec Shelbrooke MP asked questions in parliament.

Clinical Trial Transparency. The consultation currently occurring in Europe regarding the registry and publication of Clinical Trials.

Medical Records. The use of the Clinical Practice Research Datalink Group to assess Anti Epilepsy Drugs (AEDs) and whether there is a biological link between parents notes and their biological offspring notes to enable observational research into teratogens and products that may affect sperm.


4th November 2013

Dr Ian Hudson, Chief Executive of the MHRA confirmed that Sarah Morgan from the Vigilence and Risk management team at the MHRA will be aiding the European review into the use of Sodium Valproate and will keep the Department of Health up to date with progress.



29th October 2013

The meeting with Health Minister Norman Lamb MP was rescheduled. 

Branwen Mann attended representing FACSAWARE with Deborah Mann.  Susan Cole attended on behalf of OACS.  Emma Friedmann attended on behalf of FACT.  Ian McLachlan a campaigner from Scotland travelled from Glasgow.  InFact and Facsa were also represented. 

The Department of Health is now aware of our concerns and Claire Phillips from the Department of Health is collating information. 

Anas Sarwar MP and Alec Shelbrooke MP were also in attendance. 


16th October 2013

MHRA confirm there will be a warning in the November issue of Drug Safety Update to remind clinicans and prescribers to check current prescribing guidelines.  Hopefully this will include specific warnings about the use of Sodium Valproate in women of childbearing potential.


14th October 2013

The MHRA request the European Medicines Agency review the use of Sodium Valproate.


29th September 2013

Emma Friedmann met Alec Shelbrooke MP to discuss FACS. Parents also took part in the NHS Demonstration.

24th September 2013

The MHRA contacted Emma Friedmann to confirm they will be seeking advice from experts on the use of Sodium Valproate with the view to issue further regulation if required.

MHRA also confirm the warning in the Epilim patient information leaflet about Male Infertility relates to  'reversible testicular changes and an increased number of abnormal sperm in some rats exposed to sodium valproate'.  


3rd September 2013

Norman Lamb MP had invited representatives of FACT and FACSAWARE to parliament to discuss our concerns.  He cancelled with less than 24 hours notice.  A meeting was held in Portcullis House that was attended by read more


FACSaware supports


+AllTrials Donate Here


If medical trials were registered and published, conditions caused by pharmaceutical products would be better understood and new products without the negative side effects could be developed.




Have you been affected by Diethylstilbestrol, Distilbene?  DES Support groups.Chat on facebook.  Read more by The Independent


Have you been affected by Dexamethasone, DEX, Corticosteroid?


Have you been affected by Bendectin, Debendox, Lenotan, Diclectin? Chat on facebook See more on Youtube


Contact Us


You can reach us on:

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Other: +44 116 2200486


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You can also use our

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Email the editor:


Emma Friedmann



28 Myrtle Road


LE2 1FT in social networks #FACSaware

Valproate toolkit issued by MHRA and UK Government

The MHRA has been co ordinating a stakeholder engagement group to compile information about Sodium Valproate use in pregnancy.  FACSaware have taken an active role in attending meetings, submitting reports and liaising with parents to ensure all views are represented.

MHRA Statement

A toolkit has been finalised and was launched on 8th February 2016 to coincide with International Epilepsy Day.

 Valproate and Pregnancy Toolkit

Phase 1

The central alerting system will be used to inform NHS Trusts, NHS Trust Directors and CEOs, UK CMOs, NHS England area teams, regional directors and directors of public health, CCGs, social care providers, Non NHS reciipients on Public Health link.

Alert will be cascaded to GPs, dispensing GPs, hospital pharmacists, community pharmacists and A&E professionals.

Phase 2

Professional bodies and regulators will communicate key messages through their newsletters and bulletins.


MHRA Drug safety update will be sent to 170,000+ Healthcare professionals

Global and National awareness days will used to promote the key messages.

  • 23 March - Purple Day
  • 18-24 May - National Epilepsy Week
  • 10 October - World Mental Health Day


The Valproate stakeholder network group will continue to meet to evaluate the effectiveness of communications and implement new strategies if objectives have not been met.

Report suspected cases of Fetal Valproate Syndrome


The MHRA have a reporting system called the Yellow Card that can be used to report Adverse Drug Reactions. 

Yellow Card


 It was modified in 2013 to enable the online form to record concerns over medicines in pregnancy.

Yellow Card App


 In 2015 the Yellow Card App was launched and patients and professionals are still contributing towards its development.  


APPG - Anti Epilepsy Drugs in Pregnancy


Teresa Pearce MP has set up an APPG to look at AEDs in Pregnancy

She has sent invitations to all MPs and has requested individuals interested to contact their own constituency MP.

Take part

Is it possible for you to contact your MP and request they contact Teresa Pearce and express interest in the APPG. 
If you have any relevant files / contacts / communications etc it would be very helpful for your MP and Teresa Pearce to have a copy of these so that there is a solid place to start from and everyone's view and expertise can be taken into consideration when developing the role of the APPG.
Jo Cozens is Chair of Organisation for Anti Convulsant Syndromes and is coordinating the charity political activity.  Her contact details are:  07940 002377 or email:
Many thanks
Emma Friedmann
FACSaware campaigner

Summary of progress made in 2015. 

The European Medicines Agency PRAC review was excellent and there are now new warnings and guidelines across all EU member states.
European Medicines Agency  Pharmacovigilance Risk Assessment Committee:  

The MHRA have been working with the Department of Health and have updated and created the following documents and patient information.  Representatives from FACSaware and OACS charity have been involved in developing policy and advice.
NHS Choices information 
The DoH Social care blog 
drug safety update 
Black Triangle
A dear doctor letter.  
Patient Information 
Healthcare professional information  
Patient Information Leaflet 
Consent forms  


Valproate - EMA recommendations


Warnings have now been issued by the European Medicines Agency about the use of Valproate products in female patients with Epilepsy, Mental Health Illness and Migraine.

  • 30-40% risk of birth defect in those exposed in the womb.
  • Not to be prescribed during pregnancy for Migraine prevention.
  • Not to be prescribed as first choice treatment for Epilepsy and Mental Health illness unless all other treatments have been tried and are ineffective or not tolerated.
  • Women and girls who are prescribed Valproate should take effective contraception.

If you would like further information and support please contact

Personal note by Emma Friedmann
I am delighted with this recommendation as I have been involved in campaigning to improve warnings to Patients and Clinicians. 
I attended an MHRA Seminar in Spring 2012 to ask about Valproate use in Pregnancy and was told that further warnings would not be issued as they (MHRA) did not see the product as defective. 
I then wrote many times over the next 18months to the MHRA (UK regulator), providing them with evidence based research and explaining the implications of inaction. 
FACSaware campaigners and members of Organisation for Anti Convulsant Syndromes, charity no: 1116497 have explained to me their stories and this has informed me of necessary actions and the desire of parents to Prevent this from happening to others. 
FACSaware Campaigner Jo Cozens suggested a demonstration outside the MHRA HQ in London.  We organised it and held a peaceful demonstration in August 2013. 
In October 2013 the Chief Executive of MHRA referred Valproate to the European Medicines Agency for a review by their Pharmacovigilance risk assessment committee (PRAC). 
In November 2013 the MHRA issued further warnings in their monthly Drug Safety Update.
FACSaware contributed to the PRAC review in June 2014.  This was held in London and gave campaigners and those affected the opportunity to meet campaigners from APESAC (French group) and some of the Belgian campaign team.  
I have also been working with Alec Shelbrooke MP and requested a meeting to discuss raising awareness of Valproate.  Alec agreed and in June 2014 his APPG met. 
I was delighted by this as I had written the invitations, outlined the agenda and provided background information.  Jon Ashworth MP attended and has asked questions in Parliament to confirm the Government position.
On 13th November 2014 I was invited to the Dept of Health to discuss and contribute towards information for Patients and Clinicians and give ideas on how to disseminate that information.
I work closely with the registered charity no: 1116497, OACS.  Our next steps are to get a Judge led Public Inquiry into why it has taken so long to issue warnings and to examine why those harmed by Pharmaceutical products have been unable to hold someone to account for their injuries and to claim compensation.
I feel very positive about progress but dismayed that the warnings from regulators have been a result of Campaigners and Clinicians rather than Parliamentarians.
I am hopeful that Parliamentarians will now act for the good of their constituents and ensure appropriate guidance is given by NICE, the CQC, NHS England and Healthwatch.
People with Learning Disabilities have been badly assessed by Fit to Work programs and many are living in extreme poverty, subject to isolation and with no coherent Legal support.  This is the future for my Son and it scares me.

Thank you for your support.



Campaigners meet Alec Shelbrooke MP for APPG

On 18th June 2014 the APPG for Thalidomide and other harmful drugs prescribed during pregnancy, Chaired by Alec Shelbrooke MP met in Parliament to discuss raising awareness of FACS. 

FACSaware, OACS, FACT, FACSA, AEDiP, NHS England, MHRA, Sanofi, Epilepsy Society attended.   

There was strong support for existing Government funded registers to be used to monitor and collate information about those exposed to Sodium Valproate. 

The MHRA is collating information and will produce an information booklet when the European Review into Sodium Valproate has been completed.

Alec Shelbrooke MP will release a full report in the first week of July 2014. 





International Clinical Trials Day


Watch the new AllTrials campaign video.

Watch now

Results from around half of clinical trials have never been published. Information on what was done and what was found in these trials could be lost forever to doctors and researchers, leading to bad treatment decisions, missed opportunities for good medicine, and trials being repeated. The contributions of the hundreds of thousands of patients who took part in those trials remain unused and unusable.

All trials past and present should be registered, and the full methods and the results reported. Sign up to make clinical trials count. 75,000 people and more than 450 organisations have joined. Public pressure is already changing regulations and getting past trials published in some countries. You and everyone you know can join it at and by sharing this video.

This has to be the last International Clinical Trials Day of the era when trial results are withheld.

Ian Bushfield
Campaigns Support Officer
Sense About Science

MHRA update online Yellow Card

There were several problems when parents tried to enter details of their children's suspected adverse drug reactions on the MHRA online Yellow Card form.  Emma Friedmann has had constructive communications with the MHRA to suggest improvements to the form.

 In April 2014 the MHRA updated the Online Yellow Card and are now promoting its use issuing further guidance


European Medicines Agency Review into Sodium Valproate


The EMA review into the use of Sodium Valproate and related products started on 10th October 2013 at the request of the MHRA and is great news for Europeans affected and a huge success for campaigners seeking to improve the current system of medicine regulation and warnings issued.


Summary of UK action regarding Sodium Valproate and medicine safety.

MHRA have issued safety warnings in the November 2013 Drug Safety Update.

The EU is now conducting a review into Sodium Valproate use. UK government is represented by Sarah Morgan from the MHRA.

An All Party Parliamentary Group (APPG) has been set up and is Chaired by Alec Shelbrooke MP.

There has been an EU review into Clinical Trial transparency.

UK campaigners want professionals to have a better understanding of FACS so that people affected can be diagnosed and provided with the co-ordinated care they need.

The UK Government has not issued information to the public or professionals about FACS.

Huge cuts in public funding to local authorities are affecting the services to the disabled and their Carers.

Glenis Wilmot MEP is aware of FACS and has been involved in the EU review into Clinical Trials.

The UK Epilepsy and Pregnancy register is not accurate as it doesn’t assess children exposed to VPA for long enough.

It has been agreed by the Department of Health that the Clinical Practice Research Datalink group would be a good way to collect observational research and view trends in drug use and the effects on the developing fetus.



Raising global awareness of Fetal Anti Convulsant Syndromes and other Teratogen related syndromes.

Contact to get involved in our campaigns

Wish List, MHRA to issue drug safety updates, to ensure Yellow Card works, to regulate to prevent harm.  MHRA to safeguard the public. Protest at MHRA Headquarters in London on 2nd August 2013 Photograph by Warwick Sweeney

To contribute content to this webpage please contact: in social networks #FACSaware

The protest at the MHRA on 2nd August 2013 was organised by Jo Cozens. View more photos 

All protesters have been affected by the side effects of pharmaceutical products.  

The MHRA is the UK medicine regulator and they had refused to issue warnings about the 40% risk of birth defect with Sodium Valproate. 






Everyone was appalled with the scandal surrounding Thalidomide birth defects and the inability of those affected to hold those responsible to account in the Courts.  Debendox followed in the 1960s and since 1973 babies have been exposed to Sodium Valproate and are still being born with Fetal Valproate Syndrome (FACS) as our medicine regulators have refused to issue warnings.  Victims have been unable to pursue compensation in the UK Courts.  The most recent example was the Class action against Sanofi Aventis by children in the FACS Litigation that claimed that their deformities, Low IQ and Autism had been caused by their mothers taking Epilim (Sodium Valproate) while pregnant.  The FACS Litigation had its funding withdrawn in 2010 by the Legal Services Commission.  A Judicial review was denied and EU Law did not allow an appeal.

Facsaware wants medicine regulation to improve and arrived at the MHRA with a wish list.

MHRA to issue safety warnings in line with developing scientific knowledge.

MHRA to ensure Yellow Card works.

MHRA to proactively regulate to prevent harm. 

MHRA to stop marketing for Big Pharma.

MHRA to Safeguard the public.

Protesters travelled from Teeside, Cambridgeshire, Leicestershire, Sussex, Republic of Ireland, Cardiff, London and the home counties.  

Facsaware was represented by Branwen Mann at a meeting cancelled at short notice by Health Minister Norman Lamb MP on 3rd September 2013 at parliament.  Branwen has Fetal Valproate Syndrome as she was exposed to Sodium Valproate in the womb.  The meeting was rescheduled and took place on 29th October.

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