Latest News

The following statement was released by Epilepsy Ireland:

December 2nd

Deborah has been invited to attend Mitox 2015

 

November 23 Harry Potter, Watford

Watford has been raising money to take a group of FACS children to the Harry Potter Studio tours

 

19 November

Deborah has attended the Accelerated Access Review for Medicines in the UK

 

30 October

OACS have worked with the red cross to develop a epilepsy first aid course for those with special needs and a parent or sibling with epilepsy.

 

Summer 2015

The onus, this summer, has been on the development of community groups; OACS trustees have been visiting around the UK in order to meet the Members of OACS with the intention of developing community groups

 

13th June

Meeting with the MHRA

 

27 – 30th May

OACS attended the Euroodis Members Meeting in Madrid

 

20 May 2015

We have four new areas of support in place today.  OACS is in for the long haul, we are determined to do the best that we can for those families that we support.

 

14th May

Shook hands with BIBIC in order to provide support for the families of OACS for both the family unit and the child.

http://www.bibic.org.uk/

6th May

Ground breaking meeting with FACS specialist.

25th March 2015

O.A.C.S has gained Political attention and pulled off a high level meeting to discuss FACS, in a meeting, initiated by campaigning  

 

16th March 2015

OACS have been approached and we now have a member on the the Patient Group Consultative Forum, part of the MHRA consultation process.

 

13th March 2015

Valproate Medicines Risks and Benefits - MHRA stakeholder meeting

 

1st March 2015

OACS and Facsaware took part in the “Peoples March for the NHS” Launch in Tredegar, met with Actor Michael Sheen who is now going to look up OACS, campaign and took a keen interest as did the local MEP.  The local Mayor going to follow the OACS campaign and link up the Epilepsy groups and Autistic groups to see if they have members with FACS

 

27th February 2015

Karen Keely attended Rare Disease Day,       Ireland.  Karen was the belle of the ball, as she was called up to be presented with flowers, and a big kiss from Philip Watt, chair of Cystic Fibrosis Ireland and the MRCG, in honour of the incredible  work she has done this year, bringing concerns regarding sodium valproate to the forefront in Ireland.

 

24th February 2015

Deborah Mann, Secretary and Research Co-ordinator attended the Rare but         Real Eurodis Policy Event in Brussels.   

3rd January 2015

OACS has hit the ground at great speed for 2015 thanks to Karen/OACS fantastic work with the Sanofi Statement.  The Disability Federation of Ireland thanks Karen Keely, OACS Irish Liaison Officer, for highlighting concerns regarding sodium valproate:

15th January 2015

Nick Sireau began mentoring OACS as part of the Findacure Mentoring Scheme

 

What happened in 2014

3rd December 2014

Karen Keely of OACS in Ireland, attended many meetings, that resulted in the            outcome of the recent statement from Sanofi.

 

13th November 2014 

NHS meeting

Deborah Mann from OACS, Susan Cole from Justice for FACS and Emma Friedman for FACSaware attended the NHS meeting in order to consult with patient groups in order to find an effective method of providing information to the patient regarding the effects of sodium valproate.

 

10th October 2014

Light at the end of the tunnel medical advice to pregnant women has been wrong for 43 years.  After 12 months collaborative work, the European Medicines Agency has completed its review into Sodium Valproate

 

27th June 2014

PRAC

The Pharmacovigilance Risk Assessment Committee (PRAC) is the committee that is responsible for assessing all aspects of the risk management of medicines for human use. The main responsibility of the PRAC is to   prepare recommendations on any questions relating to pharmacovigilance activities related to a medicine for human use and on             risk-management systems, including the   monitoring of the effectiveness of those      risk-management systems. The review of valproate medicines has been requested by the UK’s Medicines and Healthcare Products    Regulatory Agency (MHRA) following the    publication of new studies suggesting that in some children problems in               development, which can include autism, may be long-lasting.   

The MHRA also noted that there was a need to update the product information of these medicines to bring them in line with current evidence. The European         Medicines Agency are now reviewing the available data on the benefits and risks of valproate and related substances and will issue an opinion on the use of these  medicines in pregnant women. All those attending have been asked not to share what happened, but we do truly believe that the outcome will be very positive. The next stage in this process will be the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh), will examine questions relating to marketing authorisation of a medicinal product. It will be after this that the EMA will make their final decision.  Attending for OACS are Deborah Mann; OACS secretary, Branwen Mann; trustee and youth representative

18th June 2014

APPG

OACS attended the Alec Shelbrooke MP, Chair of the APPG Thalidomide and other harmful drugs prescribed during pregnancy, has added Sodium Valproate birth     defects to the APPG. The purpose of this meeting was to formulate a workable strategy to raise awareness of FACS.

 

Branwen Mann attended represented the children of FACS. Jo Cozens; chairperson of OACS was also in attendance.  Karen Keely observing for OACS in Ireland North and South was able to express her thoughts.  Tim Noakes was there for the Dads and parents: Amanda and Helen Connolly and FACS person: Sophie Holmes also attended. From this meeting the government will be funding a booklet for use within the NHS. Sanofi and the epilepsy society have said that they will update their pregnancy information.

 

29th April 2014

The New Board of Trustees came on board

The New Board of OACS are taking a new proactive and interactive approach to OACS.  We are listening to your voices; we have experienced your path; we are ready to ACT.

 

29th October 2013

Norman Lamb Meeting

OACS attended a meeting with Norman Lamb MP; Minister of Care and Support with Facsaware, Ian McLachlan (a campaigner from Scotland) travelled from Glasgow. InFact and Facsa were also represented.  The intention was to put across the experiences of our children and our fears for their future. Susan Cole and Deborah Mann, attended on behalf of OACS and Emma Friedman, and Branwen Mann from FACSaware.  We were shocked to find that the governmental awareness stemmed from the epilepsy and pregnancy register.  Emma Friedman and Deborah Mann explained the concerns of FACSaware and OACS

 

2nd August 2013

London Calling Protest @ MHRA

Demonstration at the MHRA to raise awareness of Fetal Anti-Convulsant Syndromes with members of OACS Joining forces with Debendox and Emma Friedmann from the Facsaware Campaign.

 

10th March 2013

BBC Wales “The Wales ReportHuw Edwards and Helen Callaghan interview Jo Cozens and her son Tomas, after only finding out about the effects of taking Sodium Valproate during Pregnancy.  Huw Edwards also interview’s Paul Flynn MP, who’s raised the cause in Parliament and Epilepsy Action.

Following the recent European-wide strengthening of restrictions on the use of valproate in female children, adolescents, women of childbearing potential or pregnant women, the manufacturers of the drug Epilim, Sanofi have written to Irish healthcare professionals to advise them on the new restrictions. The content of the letter has been approved by the Health Products Regulatory Authority (formerly the Irish Medicines Board).

 

The letter, dated December 3rd has been sent to neurologists, GPs, community pharmacists, hospital pharmacists, psychiatrists and other professionals who may be involved in the care of people with epilepsy, bipolar disorder and other conditions who have been prescribed the drug.

 

The letter details the risks involved and then states that "valproate for the treatment of epilepsy or bipolar disorder should not be used during pregnancy and in women of child-bearing potential unless clearly necessary i.e. in situations where other treatments are ineffective or not tolerated".

 

Prescribers are asked to "carefully balance the benefits of valproate treatment against the risks when prescribing valproate for the first time, at routine treatment reviews, when a female child reaches puberty and when a woman plans a pregnancy or becomes pregnant".

 

In cases where valproate is prescribed to a woman of child-bearing potential, "she must use effective contraception during treatment and be fully informed of the risks for the unborn child if she becomes pregnant during treatment with valproate".

Following the distribution of this letter, the next steps include the further strengthening of warnings in the drug's product information leaflet for patients and new measures to ensure that patients taking the medication, both new and existing are properly informed of the risks associated with it. Materials specifically developed for patients will be provided to all healthcare professionals and to women prescribed valproate to inform them of the risks.

 

Read the full letter sent to health professionals.

The latest issue of the HPRA's Drug Safety Newsletter also includes a detailed update on the new restrictions.

 

OACS would formerly like to thank:

 

Karen Keely, OACS Ireland

Liaison

Officer and Trustee

for all her hard work, time and commitment

to achieving this process

 

Deborah Mann Intirim Secretary and Research Co-Ordinator

For her support and the time she has taken in order to gather the necessary information

 

To the OACS parents who filled out those endless surveys

Your time and effort you took to do this provided some of that necessary information

 

Thank you to the board of trustees that supported this process.

 

To ALL the children with Fetal Anti-Convulsant Syndromes

This would not have happened if you were not there to inspire our actions.

© Copyright of Organisation of Anti-Convulsant Syndrome (O.A.C.S) 2/2014 Registered Charity no. 1116497