Campaign Update : European Medicines Agency Final Decision – Epilim NOT To Be Prescribed for Epilepsy or Bipolar Disorder

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Back in June 2013 after the Panorama Documentry “Pills in Pregnancy” aired, very shortly after we were invited to meet with head of Pharmacovigilence Dr June Raine who also featured in Panorama.

It was a very lengthy meeting and we spoke in detail of the whole topic surrounding AEDs in Pregnancy particularly Epilim as whilst taken during pregnancy poses the worst risk to the foetus.  INFACT had previously written to Ministers expressing our need for a public inquiry due to the systematic failure concerning the prescribing of Epilim, we expected it and obviously due to funding were turned down with our request.  We thought about this long and hard, how and where could we get an investigation into the prescribing of Epilim during pregnancy????  We proposed to Dr Raine and her team that this was investigated at the highest level you can get to….. European Medicines Agency, and were delighted when this was sanctioned.

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We were told this would be a lengthy investigation as it involved other EU states, but we needed this time to prepare all our evidence…..and we had a lot.  We produced a National Survey, in which MHRA (Medicines Healthcare and Regulatory Agency) had viewed before we submitted it to the public, in which would be used as evidence, and the results of this survey were outstanding.  With every question it proved system failure on all levels and have since been told it was a much needed contributing part of the investigation.

Another big part of our evidence was to hear from our families, what their experiences of taking Epilim was and how it had affected themselves and their families.  Preparing these documents was heartbreaking.  Hearing from other mums how their babies had been affected, the impact it had on their families and also how they felt as mums.  Very tough and distressing, but looking back we are glad we submitted these case studies and yet again there were a lot.

It has been nearly a year now and the Official Results of the PRAC Assessment have come back.

EPILIM IS NOT TO BE PRESCRIBED TO ANY LADY WITH EPILEPSY OR BIPOLAR DISORDER

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We were always  hopeful it would come back this way, as over the years the evidence with regards to Epilim and Birth Defects has continued to get stronger and stronger.  So as it stands EPILIM (Sodium Valproate) WILL NOT be prescribed to any lady of child bearing age with regards to Epilepsy / Bipolar Disorder and any other condition.  A brilliant result for all those involved.

At our 1st initial meeting with DR Raine and her team we expressed our concern about the reporting system Yellow Card Scheme, how on the form there was no where to report the effects of medication to the baby.  For the last year we have been working with them on this and can now say this has been changed .  The Yellow Card Scheme was initiated following The Thalidomide Scandal and was made available for all Practitioners and Patients to report and adverse side affects of their medicine.  On 25th November we were invited to attend 50th Anniversary of Yellow Card Scheme – an event to celebrate some of the achievements of this scheme but also a chance to discuss how to make it better. IT was a great day and we are thrilled to be involved in such a poignant initiative.

With regards to the prescribing of Epilim in UK it is now upto MHRA, Department of Health and Government to make sure ladies are fully informed of the risks of prescribing during pregnancy.  INFACT are involved with this and we have had meeting after meeting with different departments and health care professionals about this and will continue to do so until the message is loud and clear.

INFACT / FACSA want to sincerely thank each and every parent that gave us their account of how taking Epilim has affected your family.  They were all in great detail and we understand it must have been hard writing this, but you have helped make a difference.  Your voice has been heard and helped change the prescribing of Epilim.

Finalised Survey Results – Epilim (Sodium Valproate)

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INFACT Survey into Sodium Valproate was devised with the help of MHRA (Medicines Healthcare Regulatory Agency).  It was a 40 question survey going into a lot of detail, the questions and answers below are the questions with percentages attached

 

Q 1 ) What medical condition do you suffer from?

  • Epilepsy                      95.83%
  • Bipolar Disorder     1.39%
  • Migraine                     1.39%
  • Unsure                         1.39%

Q 2)  How old were you when you first received regular Sodium Valproate for the condition?

  • 16 years or below                       15.28%
  • Between 10-15 years                 29.17%
  • Between 15-20 years                 30.56%
  • Over 20 years                                25.00%

Q 3)  Was Sodium Valproate the first drug your doctor prescribed?

  • Yes      55.56%
  • No       44.44%

Q 4)  Who first prescribed Sodium Valproate?

  • GP                                  11.11%
  • Specialist                 75.00%
  • Cant remember          6.94%
  • Other                                6.94%

Q 5)  Who continued to prescribe your Sodium Valproate after the first prescription?

  • GP                         50.00%
  • Neurologist        40.28%
  • Other                         9.72%

Q 6)  Did you discuss contraception with a healthcare professional?

  • Yes                                     45.83%
  • No                                         48.61%
  • Cant remember                   5.56%

Q 7)  Did you discuss getting pregnant with your doctor before conceiving?

  • Yes                                    36.11%
  • No                                      58.33%
  • Unsure                                 5.56%

Q 8)  Were all of your children exposed to Sodium Valproate?

  • Yes                            54.17%
  • No                              45.83%

Q 9)  Have all your children been adversely affected by Sodium Valproate during pregnancy?

  • Yes                              36.11%
  • No                                52.78%
  • Unsure                           11.11%

Q 10)  If the pregnancies were planned, did you receive counselling on the known risks?

  • Yes                                          18.06%
  • No                                            76.39%
  • Cant remember                      5.56%

Q 11)  Were you offered or switched to a different medication other than Sodium Valproate prior to conceiving?

  • Yes                                           13.89%
  • No                                             80.56%
  • Unsure                                        5.56%

Q 12)  After being prescribed Valproate for some time, was it ever suggested to you to change your medication before becoming pregnant?

  • Yes                                                16.67%
  • No                                                77.78%
  • Cant remember                        5.56%

Q 13)  Was it ever suggested to you, after taking Valproate for a lengthy period and having no seizures to reduce or even stop the medication?

  • Yes                                                                     12.50%
  • No                                                                      50.00%
  • Seizures never stopped                            33.33%
  • Cant remember                                                 4.17%

Q 14)  How well was your condition controlled during pregnancy?

  • Well controlled                                               61.11%
  • Uncontrolled                                                  31.94%
  • Cant remember                                                  6.94%

Q 15)  Did the dose of your medication have to change?

  • Yes                                                                           16.67%
  • No                                                                            51.39%
  • Cant remember                                                   6.94%
  • Yes before pregnancy                                      2.78%
  • During pregnancy                                           22.22%

Q 16)  How old was the neonate/child when the problems were first noticed?

  • Birth-6 months                                                  54.17%
  • 6-12 months                                                       13.89%
  • 1-5 years                                                              30.56%
  • 5-10 years                                                            12.50%
  • Over                                                                            5.56%

Q 17)  What were the problems first noticed?

  • Spina Bifida                                                                6.94%
  • Heart Defects                                                          16.67%
  • Limb defects                                                             19.44%
  • Facial features                                                         33.33%

Q 18)  What if any of the following Developmental Problems have been noticed in your child?

  • Motor Control Problems                                                 61.11%
  • Speech delay                                                                        62.50%
  • Reduced Cognitive Functioning                                  48.61%
  • Social Difficulties                                                               66.67%
  • Autistic Spectrum Disorders                                        50.00%
  • Behavioural Problems                                                    50.00%
  • ADHD                                                                                     30.56%

Q 19)  How old was your child when any specialist referral took place?

  • At birth                                                                                 36.11%
  • 1-5 years                                                                               41.67%
  • 5-10 years                                                                           16.67%
  • Over 10                                                                                  5.56%

Q 20)  Was it explained to you that your child may be at risk from Fetal Anti Convulsant Syndrome?

  • Yes                                                                                          26.39%
  • No                                                                                           70.83% 
  • Cant remember                                                                  2.78%

Q 21)  Was there any correspondence/letter sent to you from the specialist confirming a diagnosed condition?

  • Yes                                                                                        34.72%
  • No                                                                                          52.78%
  • Cant remember                                                                12.50%

Q 22)  If you received a letter of diagnosis was any information given to you explaining the diagnosed condition to you?

  • Yes                                                                                        8.33%
  • No                                                                                        73.61%
  • Cant remember                                                             18.06%

Q 23)  Were you asked to complete a Yellow form by your Doctor reporting your childs symptoms?

  • Yes                                                                                    2.78%
  • No                                                                                    83.33%
  • Cant remember                                                          13.89%

Q 24)  If you did not complete the yellow form, to your knowledge, did your doctor complete one reporting your child being affected by your medicine?

  • Yes                                                                                 1.39%
  • No                                                                                 56.94%
  • Not sure                                                                      41.67%

Q 25) Were you made aware of, by your doctor, specialist and or GP, any support groups/organisations, locally or nationally who could help and give advice on Valproate in Pregnancy?

  • Yes                                                                               12.50%
  • No                                                                                  81.94%
  • Cant remember                                                         5.56%

Q 26)  Would you like to receive any of the following?

  • FACSA leaflet                                                            90.00%
  • INFACT Leaflet                                                        80.00%
  • Parent Guide                                                             85.00%
  • Education Guide                                                      80.00%

 

 

Campaign Update – APPG – Annual General Meeting

 

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On 18th June 2014 our APPG AGM (All Party Parliamentry Group- Annual General Meeting)  for Thalidomide and Other Harmful Drugs in Pregnancy.  As we are working very closely with Thalidomide Campaign Team INFACT were invited to be members of this Party due to our on – going campaign.  Normally with an APPG it is only the members and MPs  who attend the meeting but as this was the AGM  any persons could attend the meetings (with an invite)  Those in attendance were Drug Manufacturer Sanofi, NHS England,  AEDiP, MHRA, MPs, OACs , parents of affected children , Janet our Educational Officer Catherine and myself

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The agenda of yesterday’s meeting was basically to discuss the issues surrounding Epilim (Sodium Valproate) and what next steps were needed.  Janet and I have been in contact with Dr June Raines from MHRA since last year, and when we met last we expressed our concerns that currently in NHS there are no information booklets with regards to how taking Epilepsy medications can affect the baby during pregnancy.  It is now official that INFACT are producing booklets to go in every clinic in NHS where Anti Epileptic Drugs are prescribed.  We have been working on this for a very long time, and is still in draft mode with a lot more work to do, but the fact we are doing this is just fabulous.  The fact that we are helping educate ladies about this topic is the reason I decided to speak out about my families experience with Epilim, it feels right.

It was a very positive meeting and I personally enjoyed meeting other parents.  Meeting mums who had been fed a lot of lies having never met me gave me the chance to put all the jealous and bitter accusations to bed. It amazes me the  lengths people will go to involving innocent people on their merry go round.  What have they actually achieved out of it ???? Yep nothing,    Very sad !

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Hearing their experiences of how Epilim had affected them  was heartbreaking.   These mums like myself have been dealt a huge injustice.  Hearing also about the lack of support we as parents get with our kiddies and the continuous fight we have with local authorities and education.  We are also hopeful that a database will be worked upon with Thalidomide Campaign team by which, mothers on medication and their children will be registered on a database, so that for the future, all information about medicines and the ladies on them will be collated.

In Parliament that day we also met TV Presenter Kate Garraway.  I get so celebrity struck when I see famous people.  I ran over to her for a quick picture, and she was so lovely.  She must have thought I was a deluded woman !!! I was just excited.  My kids were made up when they saw the picture.

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We are now preparing for the European Review into Epilim as we are giving evidence.  We have an awful lot of evidence to put forward and I will update you all after the event

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Last piece of good news is that INFACT are now a registered Company/Trust.  We were advised to do this by our solicitors, with regards to the nature of our campaign and the fact that we are seeking compensation on behalf of the thousands of affected peoples by AEDs.  We are now official and little old me is named as the Managing Director :J) With Janet being CEO

 

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New Parliamentry Question Answered

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A few months back we met with Luciana Berger MP.  She was very supportive of our campaign and has since submitted a parliamentry question with regards to the removal of Pre Conception councilling  (QoF) for ladies with Epilepsy.

7 April 2014

Luciana Berger: To ask the Secretary of State for Health (1) what representations his Department received before the removal of pre-conception counselling for women taking anti-epilepsy medications from the Quality Outcomes Framework; [194769]

(2) what assessment his Department has made of the risks of removing pre-conception counselling for women taking anti-epilepsy medications from the Quality Outcomes Framework. [194770]

Dr Poulter: Senior NHS England clinicians and representatives of the British Medical Association reviewed and agreed all the proposed changes to the Quality and Outcomes Framework (QOF) taking into account the views of the National Institute for Health and Care Excellence (NICE) and Public Health England.

The removal of QOF indicators will not mean that general practitioners (GPs) will no longer tackle important health issues such as pre-conception counselling for women taking anti-epilepsy medication. Rather, the aim is that reducing QOF will help free up time to enable GPs to spend more time on providing more proactive co-ordinated and individual care for their patients, based on their clinical judgment.

Since 1 January 2014, Ministers have not had any meetings to specifically discuss the removal of pre-conception counselling for women taking anti-epilepsy medications from the QOF.

 

30 April 2014

 

Luciana Berger: To ask the Secretary of State for Health pursuant to the answer of 7 April 2014, Official Report, column 38W, on epilepsy, what meetings (a) Ministers and (b) officials in his Department had before 1 January to discuss the removal of pre-conception counselling for women taking anti-epilepsy medications from the Quality and Outcomes Framework; and how many such meetings were with Sanofi. [196753]

Norman Lamb: There have been no meetings involving Ministers or officials with Sanofi on the removal of the indicator in the Quality and Outcomes Framework (QOF) regarding pre-conception counselling for women taking anti-epilepsy medications.

The changes to the QOF are part of a wide ranging set of changes to the general practitioner (GP) contract for 2014-15. It is intended that these contract changes will encourage GPs and their practice teams to provide more personalised and proactive care for patients.

Changes to the QOF were negotiated with the General Practitioners Committee, which is part of the British Medical

 

 

Sodium Valproate Safety Update

This was following INFACTs meeting with the MHRA in August last year… A safety update was officially released

 

Drug SafetyUpdate

Volume 7, Issue 4 November 2013

Latest advice for medicines users

Sodium valproate: special reminder on risk of neurodevelopmental delay in children following maternal use—not for use in pregnancy unless there is no effective alternative

Article date: November 2013

Summary
There is new evidence on neurodevelopmental delay in children following maternal use of sodium valproate. A European review is underway to evaluate all currently available evidence on the association between fetal valproate exposure and neurodevelopmental delay or autism spectrum disorder

Healthcare professionals are reminded that sodium valproate should not be used during pregnancy and in women of childbearing potential unless clearly necessary. Women of childbearing potential should not start treatment with sodium valproate without specialist neurological or psychiatric advice as appropriate depending on the indication. Adequate counselling should be made available to all women of childbearing potential to weigh the risk of teratogenic and neurodevelopmental effects against the benefits of treatment

Sodium valproate (brand name Epilim) has been authorised since 1973 for the treatment of epilepsy. Depakote is the brand of sodium valproate authorised for the treatment of the manic phase of bipolar disorder.

Risks during pregnancy

It is well established that women who take antiepileptics during pregnancy have a higher risk of having a child with a birth defect than do women in the general population—this risk is estimated to be 2–3 times higher. This risk is further increased if a woman takes more than one antiepileptic medicine during pregnancy.

The use of sodium valproate is associated with a greater risk of some types of these malformations (in particular neural tube defects) than with some other antiepileptic drugs. This risk is clearly reflected in the product information provided for patients and prescribers.

In recent years, results of further studies have emerged that indicate a risk of long term neurodevelopmental effects after in uteroexposure to sodium valproate. These studies have highlighted that in some children the effects appear to persist and manifest as a range of neurodevelopmental abnormalities and autism spectrum disorders. These emerging data also suggest that these risks may be independent of maternal confounders.[1] [2] [3] [4]

The most recent publications on an association between fetal valproate exposure and neurodevelopmental delay or autism spectrum disorder have prompted a re-evaluation of the balance of benefits and risks of this medicine. The review is now underway in Europe, and further updates will be issued in due course. In the meantime, healthcare professionals are reminded of the following advice:

Advice for healthcare professionals:

  • Sodium valproate should not be used during pregnancy and in women of childbearing potential unless clearly necessary
  • Women of childbearing potential should not start treatment with sodium valproate without specialist neurological or psychiatric advice as appropriate depending on the indication
  • Adequate counselling should be made available to all women of childbearing potential to weigh the risk of teratogenic and neurodevelopmental effects against the benefits of treatment
  • In the bipolar disorders indication, cessation of sodium valproate treatment should be considered if there is an effective alternative
  • If sodium valproate is to be used during pregnancy, the lowest effective dose is recommended divided over the day or controlled-release tablets to avoid rapid peaks in plasma level
  • Folate supplementation should be started before pregnancy as appropriate
  • Specialist prenatal monitoring should be instigated to detect possible occurrence of neural tube defects or other malformations when valproate has been used

Further information

Product information for Epilim and Depakote

Article citation: Drug Safety Update volume 7 issue 4, November 2013: A2.

References

  • 1 Meador KJ, et al. Lancet Neurol 2013; 12: 244–52.
  • 2 Bromley R, et al. J Neural Neurosurgery Psychiatry 2013; 0: 1–7.
  • 3 Christensen J, et al. JAMA 2013; 309: 1696–703.
  • 4 Veiby G, et al. Epilepsia 2013; 54: 1462–72
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European Review into Sodium Valproate

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The last few months Janet and I have been so busy with regards to where our National campaign is presently at. For the past year we have been holding meetings with MHRA (Medicines Healthcare Regulatory Agency) about the surrounding topic of Epilepsy mediciations being taken during pregnancy. When we first met with them we explained in depth how bad the present situation is and they agreed with our figures that approximately 20,000 children have been harmed by Epilepsy drug Epilim. There were many things we discussed and are still working on them also but one of the points we raised was for Epilim to be looked at again. A lot of emerging evidence has been reported in the last few years in medical journal papers stating that if a foetus is exposed to Sodium Valproate there is a risk that 40% of the exposed babies could have the chance of developing Neuro Development Disorders (Autism) We expressed that this figure is to high and naturally they also agreed.

INFACT (me and Janet) initiated that a European Review should be held by the European Medicines Agency as Sodium Valproate is sold in Europe and worldwide. Believe it or not they actually agreed to this. The meeting is held under PRAC (Pharmacovigillence Risk Assessment Committee) and this means that all evidence with regards to Sodium Valproate has to be submitted so that every bit of data can be looked at and assessed. Sanofi (drug company) have been ordered to produce all evidence of clinical trials and other information they held before Sodium Valproate was licscensed.

We have been told by MHRA and we both can’t believe this, but never before have a patient group/organisation ever been involved at the European Medicines Agency and PRAC with any drug or health issue. We are representing all women taking Epilepsy medicines in UK and to be told we have set a prescedent, it’s just fabulous. To us we are just mums fighting for our children.
Our involvement with this has been very personal. We have asked all our mums on our database to write down an case studies of what has happened to them, with regards to before they were pregnant to how it affects them to this day. The amount of ladies that got in touch and provided their stories is overwhelming. When I was typing them out, with every case I was in tears. The heartbreak of what the parents have been through, with dealing with their epilepsy to go through pregnancy and then dealing with a poorly child, and cases where people don’t believe what you were saying. Families have had break ups, both parents have had break downs and that is without the lack of help and support within Health and Education. We also comprised a 40 question survey and this survey based on our results backs up everything these case studies have said, total system failure from the MHRA to Department of Health and Drug Company. The date has been set for INFACT and our colleagues (other groups affected by Epilim) in France and Belgium to present all our evidence and this will happen at the end of June. We have also found out this week our INFACT logo has officially been trademarked
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Our next meeting is 18th June our Annual APPG with Alec Shellbrooke MP and our colleagues from Thalidomide Campaign Team. This is always a great meeting as everyone that attends MPs etc are all passionate about this cause and all come up with different opinions and advise different routes for us to go down. We also get to catch up with Nick, Guy and Mikey from the Thalidomide Campaign Team. We normally go for lunch and spend a good 3-4 hours together explaining where we are up to. Their advice is imperative to us as they have been through this and won, and so to have them fully backing us, you just can’t get better.

If you are a woman reading this and have taken ANY Epileptic medicine such as
Phenytoin
Ethosuximide
Carbamazepine
Valproate
Lamotrigine
Topiramate
Zonisamide
please spare a few moments to fill in our survey https://www.surveymonkey.com/s/ZDSDNDV