EMA Recommends Strengthening Restrictions on Valproate Use in Woman

Global Success for all the Patient led Groups across Europe

OACS Charity is overwhelmed with the success that their members that took part had a significant part to play in the decision making processes of the Committee back in June.

PRAC recommends strengthening the restrictions on the use of valproate in women and girls

Women to be better informed of the risks of valproate use during pregnancy

The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended strengthening the restrictions on the use of valproate medicines due to the risk of malformations and developmental problems in children exposed to valproate in the womb.

Valproate should not be used to treat epilepsy or bipolar disorder in girls and in women who are pregnant or who can become pregnant unless other treatments are ineffective or not tolerated. Women for whom valproate is the only option after trying other treatments, should use effective contraception and treatment should be started and supervised by a doctor experienced in treating these conditions.

Women who have been prescribed valproate should not stop taking their medicine without first consulting their doctor.

In countries where valproate medicines are authorised for the prevention of migraine, women must not use valproate for preventing migraine when they are pregnant. Pregnancy should be excluded before starting treatment for migraine, and women should use effective contraception.

The PRAC also recommended that doctors who prescribe valproate provide women with full information to ensure understanding of the risks and to support their decisions.

These recommendations follow a review of available data on the effects of valproate exposure during pregnancy. During the review the PRAC also consulted representatives of patients and families who have been affected as well as a group of experts and specialists. While valproate remains an option for patients where other treatments have failed or are not tolerated, the Committee concluded that women and healthcare professionals need to be better informed about the risks of valproate exposure in the womb and of the need for effective contraception.

Recent studies have shown a risk of developmental problems of up to 30 to 40% in pre-school children exposed to valproate in the womb, including delayed walking and talking, memory problems, difficulty with speech and language and lower intellectual ability.

In addition, data show that children exposed to valproate in the womb are at an approximately 11% risk of malformations at birth (such as neural tube defects and cleft palate) compared to a 2 to 3% risk for children in the general population. Available data also show that children exposed to valproate in the womb are at increased risk of autistic spectrum disorder (around 3 times higher than in the general population) and childhood autism (5 times higher than in the general population). There are also limited data suggesting that children exposed to valproate in the womb may be more likely to develop symptoms of attention deficit hyperactivity disorder (ADHD).

The PRAC recommended that educational materials should be provided to all healthcare professionals in the EU and to women prescribed valproate to inform them of these risks. Doctors will be required to review the treatment of girls and women on a regular basis, including at puberty and when a woman plans to become pregnant. The PRACemphasised that women should not stop taking valproate without first consulting their doctor.

See this link for full details

http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fnews_and_events%2Fnews%2F2014%2F10%2Fnews_detail_002186.jsp&mid=WC0b01ac058004d5c1

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For more information about Fetal Anti Convulsant Syndrome you can contact us between

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O.A.C.S Liaison Officer for Ireland:-  Karen Keely Walsh

Email: karen7411@live.ie

 

Contact us for caring and understanding support.

REMEMBER! We’ve experienced this too!

OACS Newsletter

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OACS Sept Newsletter Final Pre Post 28.09.2014 v2 (1)

OACS Newsletter, 

Thank you to everyone that has contributed, hope you all enjoy it.
Fantastic Art Competition in there open to all the children affected by Fetal Anti-Convulsant Syndrome!

OACS are the only Charity set up to Support families and children affected by Fetal Anti-Convulsant Syndrome

OACS was established in January 1999 and became a registered Charity in 2006.

OACS is a support group for those who were born with a Fetal Anti-Convulsant syndrome (FACS) and their carers.  It was created by those that love and care for those affected.  Today OACs is proactive in their approach, determined to make a real difference in the lives of those affected and of those that care for them.

FACS is caused when a fetus is adversely prenatally exposed to anti-convulsant medication.  Today it is not known why some people are susceptible and others are not, so it is important to seek advice from a medical professional before getting pregnant. 

OACS provide information and support for those prenatally affected by AED’s, their carers and the professionals who support them.

OACS promotes awareness and an understanding of FACS.
OACS is proactive in their approach, creating initiatives to enhance our present understanding of FACS and its affects. 

Registered Charity Number 1116497

Fetal Valporate Neurodevelopmental Effects “What Next? Another Operation”

Having a child that has been effected by Sodium Valproate, you never know what is lurking around the corner!

This week has been extremely difficult for me. Tomas has had issues since a baby with his ears, they use to bleed at times this was very difficult.

Tomas had his Adenoids and Tonsils out at the age of 3-4, a grommet in his left ear.

3rd of March Tomas had to go in for his fifth operation connected with his Fetal Valproate Neurodevelopmental Effects, for the last 18 months he’s had a constant stream of fluids running down his right ear, the doctors have prescribed ear drops and in the last 6 months he’s had approx 5 lots of ear drops. Tomas had a hearing test in January and the Ear Nose and Throat Consultant had his hearing tested, he showed hearing loss in the right ear. The consultant advised that he required a grommet, I was a little concerned that he had to have an operation like any parent would but having had the procedure before I was happy.

Tomas has aspergers and the day of the operation was a complete stress explosion! He was on the anaesthetists trolley, waiting for the needle and he had a complete melt down, they were really good his whole body was trembling he was in shock. The anaesthetist eventually persuaded Tomas to have Gas & Air that he called laughing gas and eventually the needle went in, off I went, he gave big yawn as a tears rolled down my face.

Dave an I were waiting what seems like for ever for Tomas to be wheeled back to the ward like all the other kids but instead the surgeon was walking towards us! My stomach dropped as he asked do you mind if I sit down, (that never sounds good) he said I am really sorry but I was unable to fit Tom’s grommet. (I thought oh no he has another ear infection again)

what he then explained seemed to go into a bubble, “Tomas has a Retraction Pocket with a Cholesteatoma”

In plain English what this is “Cholesteatoma is a destructive and expanding growth consisting of keratinizing squamous epithelium in the middle ear and/or mastoid process. Although these are not strictly speaking tumours or cancers they can still cause significant problems because of their erosive and expansile properties resulting in the destruction of the ossicles as well as their possible spread through the base of the skull into the brain. They are also often infected and result in chronically draining ears.”

Symptoms

The majority (98%) of patients with cholesteatoma have ear discharge or hearing loss or both in the affected ear.
Other more common conditions, such as otitis externa may also present with these symptoms, but cholesteatoma is much more serious and should not be overlooked. If a patient presents to a doctor with ear discharge and hearing loss, the doctor should consider the patient to have cholesteatoma until the disease is definitely excluded.

Other less common symptoms (all less than 15%) of cholesteatoma may include: pain, balance disruption, tinnitus, ear ache, headaches and bleeding from the ear. There can also be facial nerve weakness. Balance symptoms in the presence of a cholesteatoma raises the possibility that the cholesteatoma is eroding the balance organs, which form part of the inner ear.

Some children with Fetal Valproate Syndrome/Neurodevelopmental Effects, their tubes in the Middle Ear are not formed correctly causing them to have wet ears that in turn causes this problem with the Retraction Cholesteatoma’s.

There is no one in government that will step forward to help our children, I work full time and have to fight this on my own, with all the other parents in the same situation. We are all taking our kids back ad forth to hospital and GP appointments up and down the UK & Republic of Ireland. Please pass my blog around to someone anyone that will listen.

If you need help Please Contact:-

The only UK Registered Charity for Fetal Anti Convulsant Syndrome. FACS

Reg No.1116497 – Organisation for Anti-Convulsant Syndrome (OACS)

Has been there for families affected by Epilepsy drugs in the UK and has advised families Internationally.

http://www.oacs-uk.co.uk If you have been taking, Sodium Valproate or any other Epileptic Medication and need advice contact OACS.

 

“Fetal Valproate Neurodevelopmental Effects”

A New Label but the same drug at the heart of the problem!

Sodium Valproate

This seems to be the new diagnosis that specialists are now giving deformities, Neurodevelopmental Delays and Autism, caused by the drug Sodium Valproate.  Since my journey started in February 2013, I have now got this diagnosis for Tomas, this has answered one question but now I have so many more!

This new label that runs along side of Fetal Valproate Syndrome, as the effects of the drug Sodium Valproate, will it be recognised and counted exactly the same way or will the MHRA start the count to zero and say we’ve only had a few people diagnosed with?

When I have asked this question I haven’t been able to get a clear answer why?

What defines Fetal Valproate Syndrome different to Fetal Neurodevelopmental Effects, parents are experiencing different levels of continuity when they seek diagnosis and it very much a postcode lottery, as many GP’s don’t recognise Fetal Valproate Syndrome (FVS).

If you need help Please Contact:-

The only UK Registered Charity for Fetal Anti Convulsant Syndrome. FACS

Reg No.1116497 – Organisation for Anti-Convulsant Syndrome

Has been there for families affected by Epilepsy drugs in the UK and has advised families Internationally.

http://www.oacs-uk.co.uk If you have been Taking Epilim, Sodium Valproate or any other Epileptic Medication and need advice contact OACS.

 

End of One Chapter onto the Next

Thursday the 12th September 2013, this is the day I finally get the Diagnosis for my Son Tomas!

I get home from a late shift at work to find a letter on the table from a renowned Doctor with a diagnosis for Tomas.

As I read the letter I was shaking, finally the closure of one chapter in my fight for justice.

Tom’s diagnosis was “Fetal Valproate Neurodevelopmental Effects” this was a label to combine all the issues from the drug that Tom has.   I cried today for many reasons sadness, relief and anger, so many things swimming about in my head right now.  All I can think about is the overwhelming sickness inside of if only I hadn’t taken the drug.  I followed the guidelines I received from my clinicians at the time, I only wish I could rewind back the time.

Now that I know more, I am now able to step up another level and really fight for changes in the system to stop, any other parents having to wait for the sort of diagnosis I have had.

You can reach us on:

For any help contact OACS http://www.oacs-uk.co.uk 

Having a Fetal Valproate Child you Never Know whats Next!

Being measured for special insoles to help straighten his feet whilst walking!

This is what we as parents go through on a daily basis, never knowing what we are going to find next!

I believe the drugs that I took for my Epilepsy caused my son’s Autism and physical problems.

Due to legal reasons these are my own opinions

Is this right where is the follow up, once we as women take Epilepsy drugs during pregnancy?

We are told to fill in a Yellow Card by the MHRA, to tell them all that is wrong with our drugs and what symptoms our Children have.

Shouldn’t they put steps in place to stop this in the first place?

“DO NOT STOP TAKING YOUR MEDICATION and READ the PATIENT INFORMATION LEAFLET ask your doctor to explain it to you, it’s been updated quite a few times in the last couple of years.

Also read the NICE guidelines [2012] and the updated BNF.
Epilepsy treatment advice has been changed to reflect developing scientific knowledge showing 40% chance of birth defect in babies exposed to Sodium Valproate. Unfortunately the UK medicine regulator (MHRA) refuse to issue warnings so GPs still aren’t being advised. This is why http://www.facsaware.net are protesting. We as patients should be able to make an informed decision and this isn’t being provided at the moment. Meeting on 3rd Sept with Health Minister Norman Lamb MP to discuss this issue.”

You can reach us on:

UK: 0116 2200486

Other: +44 116 2200486

Chat on Facebook

Follow us on Twitter: @facsaware

Email the editor:

editor@facsaware.net

Emma Friedmann

FACT

PO Box 30

Leicester

LE1 7ZX

MHRA Need to move quickly on Regulations to Stop Harm to Babies

MHRA Need to move quickly on Regulations to Stop Harm to Babies

The drugs now causing birth defects are anti epilepsy drugs, with the ingredient sodium valproate. The defects are varied but include spina bifida, cleft palate, and neuro-developmental disorders. The drugs including Epilim, used since 1978, and associated with Fetal Anticonvulsant Syndrome (FACS), and birth defects for almost as long as it has been available. The characteristic facial features are a thin upper lip, small crowded teeth and wide nasal bridge. Whilst the effect of sodium valproate is not the dramatic loss of limbs, as is the case with Thalidomide, the effects are life limiting and debilitating.

Learn more: http://www.naturalnews.com/035933_Epilim_birth_defects_thalidomide.html#ixzz2cKniE5k9

My Story

I was too late but I want others to know the truth and to get the right advise.

Emma Friedmann of http://www.facsaware.net says

“DO NOT STOP TAKING YOUR MEDICATION and READ the PATIENT INFORMATION LEAFLET ask your doctor to explain it to you, it’s been updated quite a few times in the last couple of years.
Also read the NICE guidelines [2012] and the updated BNF.
Epilepsy treatment advice has been changed to reflect developing scientific knowledge showing 40% chance of birth defect in babies exposed to Epilim. Unfortunately the UK medicine regulator (MHRA) refuse to issue warnings so GPs still aren’t being advised. This is why www.facsaware.net are protesting. We as patients should be able to make an informed decision and this isn’t being provided at the moment. Meeting on 3rd Sept with Health Minister Norman Lamb MP to discuss this issue.”

You can reach us on:

UK: 0116 2200486

Other: +44 116 2200486

Chat on Facebook

Follow us on Twitter: @facsaware

Email the editor:

editor@facsaware.net

Emma Friedmann

FACT

PO Box 30

Leicester

LE1 7ZX

MHRA Need to Ensure Pregnant Women Get the Message

MHRA Need to Ensure Pregnant Women Get the Message

My Story

I was too late but I want others to know the truth and to get the right advise.

Emma Friedmann of http://www.facsaware.net says

“DO NOT STOP TAKING YOUR MEDICATION and READ the PATIENT INFORMATION LEAFLET ask your doctor to explain it to you, it’s been updated quite a few times in the last couple of years.
Also read the NICE guidelines [2012] and the updated BNF.
Epilepsy treatment advice has been changed to reflect developing scientific knowledge showing 40% chance of birth defect in babies exposed to Epilim. Unfortunately the UK medicine regulator (MHRA) refuse to issue warnings so GPs still aren’t being advised. This is why www.facsaware.net are protesting. We as patients should be able to make an informed decision and this isn’t being provided at the moment. Meeting on 3rd Sept with Health Minister Norman Lamb MP to discuss this issue.”

You can reach us on:

UK: 0116 2200486

Other: +44 116 2200486

Chat on Facebook

Follow us on Twitter: @facsaware

Email the editor:

editor@facsaware.net

Emma Friedmann

FACT

PO Box 30

Leicester

LE1 7ZX

MHRA Protester’s Send a Clear Message!

MHRA Protester’s Send a Clear Message!

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 will be represented by Branwen Mann at a meeting with 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.

 

Contact us

 

You can reach us on:

UK: 0116 2200486

Other: +44 116 2200486

Chat on Facebook

Follow us on Twitter: @facsaware

Email the editor:

editor@facsaware.net

Emma Friedmann

FACT

PO Box 30

Leicester

LE1 7ZX

 

Paul Flynn MP’s Blog “Worse than Thalidomide”

Paul Flynn MP’s Blog “Worse than Thalidomide”

Worse than Thalidomide

MP Paul Flynn supports the campaign for FACS (Fetal Anti-Convulsant Syndrome)

Support your MP’s spread the word #facsaware 

100 MPs have signed Early Day Motions showing support to FACS in the UK.  

Please ask your MP to sign.  1035 1021 1197 9

http://www.facsaware.net/ #facsaware