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


French campaigners have secured legal action and compensation has been awareded in Court for Depakine Valproate birth defects.


Swiss campaigners are pursuing legal action against Sanofi.  ASSAC is an organisation set up to support Swiss vicitms.


Belgian families are supporting each other and will also be pursuing justice.


The French regulator referred Valproate to the European Medicines Agency PRAC to assess the effectiveness of the warnings issued in 2015.


A Public Hearing was held at The EMA offices in London and was attended by those affected from UK, Eire, France, Belgium and Switzerland.

There was a lot of media coverage search #EMAPublicHearing and #valproate for links to news items and comment.


Ian McLachlan has a Youtube channel where media updates are uploaded. 


In the UK the Ministry for Justice suggest families apply for Legal Aid funding. 


FACSaware sent letters to top UK law firms requesting representation but none were prepared or willing to represent.


Successful lobbying by FACSaware got a Public Inquiriy into medicine and devices regulation and licensing into the 2017 Labour Party Manifesto.


UK #pharmaharm campaigns are seeking justice and recompense.


Please search #Primodos #Mesh #Contaminatedblood #Metalhips #Valproate #HPVvaccine. 


We need your support so please share retweet and comment.


HPV vaccine campaigners are hoping to get a thorough review of the vaccine to establish the effectiveness and potential adverse drug reactions.


Norman Lamb MP has an APPG into AEDs in Pregnancy, it will be meeting in January 2018 at the Department of Health to discuss Valproate.  At a meeting in December 2017 a Care plan and compensation package was discussed but neither agreed or disagreed.


FACSaware have submitted a report to the APPG.  Report available by request please email or visit the FACSaware facebook group.


13th December 2016

Compensation for French vicitms

A press conference was held in Paris by APESAC. They announced they would be pursuing legal action against Sanofi for Depakine birth defects.

The French government have already committed to compensating French victims.


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 and MHRA Yellow Card joined 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 worked  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 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.  From 2017 the responsible Minister is Lord O'Shaughnessy. 

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


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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.




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The team at the MHRA headquarters on 2nd August 2013 protesting about poor medicine regulation.

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