woensdag, juni 25, 2008

116. ADHD - Scientology Kerk wint WOB zaak over medicijn ADHD

Vooraf

Er is in onderzoek een directe samenhang geconstateerd tussen de gevolgen van vaderloosheid, scheiding en gezinsbreuk en de de afgelopen decennia sterk toegenomen prevalentie van de hyperactiviteitsstoornis ADHD bij scheidingskinderen.

Om deze negatieve gevolgen en symptomen van vaderloosheid en gezinsbreuk te onderdrukken, worden scheidingskinderen in de zgn. "zorgindustrie" (jeugdzorg, kinderbescherming, farmaceutische industrie, huisartsenij) vervolgens reeds op zeer jeugdige leeftijd onderworpen aan psychiatrische medicatie (Amfetamine-achtigen als Concerta en Ritalin en het nieuwste middel Strattera) en tot "dopies" gemaakt. Aan de achterliggende oorzaken van vaderloosheid en gezinsbreuk wordt daarbij echter niets gedaan.

De zorgindustrie probeert de negatieve gevolgen van de farmaceutische medicatie op jonge kinderen daarbij bovendien achter te houden en te verbloemen. De Scientology Kerk heeft in haar strijd tegen de psychiatrische medicatie van kinderen nu gelijk gekregen van de rechter. De zorgindustrieautoriteiten moeten openheid van zaken geven. In dit geval betreft het ondermeer het verhoogde risico op depressie en zelfmoord bij ADHD kinderen behandeld met het nieuwe middel Strattera. Hulde aan de Scientology Kerk daarom voor dit belangrijke resultaat voor kinderen.

Drs. P.A.N. Tromp
Vaderkenniscentrum


Kerk wint zaak over medicijn ADHD

nrc.nl - Binnenland - Door onze redacteur Frederiek Weeda- Gepubliceerd: 24 juni 2008 - 21:37

Amsterdam, 24 juni. De weigering van het College ter Beoordeling Geneesmiddelen (CTBG) om een rapport openbaar te maken over mogelijke schadelijke bijwerkingen van het psychiatrische medicijn Strattera deugt niet.

Dit blijkt uit een uitspraak, gisteren, van de bestuursrechter in Amsterdam, over een WOB-verzoek (Wet openbaarheid bestuur) van de Scientology Kerk aan het CTBG om het rapport over Strattera te publiceren. Het verweer dat openbaarmaking de privacy van patiënten zou schenden, vindt de rechter niet sterk genoeg.

In Nederland wordt Strattera (van farmaceut Ely Lilly) vooral gebruikt door kinderen vanaf zes jaar die lijden aan de psychiatrische stoornis ADHD. Het is pas drie jaar op de Nederlandse markt. Het middel is populair (nu 11.000 kinderen in Nederland) omdat dit het eerste medicijn is tegen de hyperactiviteitsstoornis ADHD dat niet is gebaseerd op amfetamine. De oudere medicijnen Ritalin en Concerta, die massaal worden gebruikt, zijn dat wel.

De Scientology Kerk verzet zich wereldwijd tegen psychiatrische medicatie. Eind 2005 werd de bijsluiter bij Strattera al aangepast omdat uit nieuwe studies in Amerika was gebleken dat één op de 227 kinderen die het slikten ‘suïcidale gedachten’ kreeg. Eén kind deed een zelfmoordpoging.

Het college krijgt zes weken om een nieuwe beslissing te nemen over openbaarmaking van het rapport over Strattera. Het moet met betere argumenten tegen publicatie komen, vindt de rechter.

Eerder stelde het college dat privacygevoelige informatie over patiënten en concurrentiegevoelige productiegegevens op straat komen te liggen als het rapport openbaar wordt. De rechter weerlegt dat: „Er is overwegend sprake van klinische onderzoeksgegevens over het gebruik van Strattera en de geconstateerde bijwerkingen.” Bovendien kunnen die gevoelige gegevens worden geschrapt, stelt de rechter.

Het college stelt ook dat publicatie de relatie met de Engelse autoriteiten op dit gebied bemoeilijkt omdat het rapport afkomstig is van het Engelse college ter beoordeling van geneesmiddelen. Volgens de rechter blijkt uit de correspondentie met de Engelsen niet dat die relatie onmogelijk wordt.


Press release: Updated warnings on the attention deficit hyperactivity disorder drug Strattera

UK Medicines and Healthcare products Regulatory Agency – MHRA Press release - 17 Feb 2006 - 11:53

Subject: Strattera

Contact: Press Office 020 7084 3535/3564 or press.office@mhra.gsi.gov.uk; Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) has led a Europe-wide review on the health risks and benefits of Strattera®, a prescription-only medicine used to treat attention deficit hyperactivity disorder (ADHD).

The conclusions of this European review are:

● overall the balance of risks and benefits of Strattera in the treatment of ADHD in children and adolescents remains positive;

● prescribers should be reminded that Strattera should only be initiated by and under the supervision of a specialist;

● warnings on the risk of seizures (fits) and abnormal heart rhythm should be included in the product information;

● the current warnings in the product information about the risk of liver disorders and suicidal thoughts and behaviour accurately reflect the available data.

As a result of this, new advice is being issued to doctors. Additionally the Patient Information Leaflet will be updated.

Dr June Raine, Director of Medicines post-licensing at the MHRA said, “We have written to health professionals to ensure that they are fully aware of the side effects of Strattera to allow them to make informed prescribing decisions. Children who are doing well on this medication should continue their treatment. If any unusual symptoms occur, medical advice should be sought.”

Patients and healthcare professionals are urged to report any suspected adverse reactions to Strattera® via the Yellow Card Scheme. They can be completed on the web at www.yellowcard.gov.uk.

Notes to Editor

1. The MHRA is the government Agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. We keep watch over medicines and devices, and we take any necessary action to protect the public promptly if there is a problem. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks.

2. Strattera® (atomoxetine) is used to help control the symptoms of attention deficit hyperactivity disorder (ADHD - inability to pay attention, impulsiveness and hyperactivity) in children and adolescents. It has been on the UK market since July 2004.

3. It is estimated that approximately 15,000 patients have been treated with Strattera® in the UK in the past year. It is not extensively used in the UK. Methylphenidate is the main drug used in the treatment of ADHD.

4. The Yellow Card Scheme enables healthcare professionals and patients to report any suspected adverse drug reaction to the MHRA. www.yellowcard.gov.uk


Updated warnings on the attention deficit hyperactivity disorder drug Strattera - information for healthcare professionals

UK Medicines and Healthcare products Regulatory Agency – MHRA - 16th February 2006


Message from Professor G Duff, Chairman, Commission on Human Medicines

16th February 2006 CEM/CMO/2006/

Dear Colleague,

Strattera (atomoxetine) – conclusions of risk:benefit review

I wrote to you in September 2005 to inform you about new evidence of an increased risk of suicidal thoughts or behaviour in association with the use of Strattera (atomoxetine). Strattera is authorised for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children of 6 years and older, and in adolescents, as part of a comprehensive treatment programme. It must be initiated by, or under the supervision of, a physician with appropriate knowledge and experience in treating ADHD.

Strattera has been marketed in the UK since July 2004 but has been available in the United States since November 2002. Worldwide exposure is estimated at 3.7 million patients as of November 2005. In light of the concern about the increased risk of suicidal thoughts and behaviour, a Europe wide review of available data on the risks and benefits of Strattera was initiated. This review has concluded that the overall balance of risks and benefits of Strattera remains positive in the treatment of ADHD in children of 6 years and older and in adolescents. However, in order to optimise the safe use of Strattera it is important that prescribers are aware of the following:

New advice to prescribers

• Seizures are a potential risk with Strattera and therefore it should be introduced with caution in patients with a history of seizure. Discontinuation of Strattera should be considered in any patient developing seizure or if there is an increase in seizure frequency.

• Reports of QT interval prolongation have been received in association with Strattera. Therefore, it should be used with caution in those with congenital or acquired long QT or a family history of QT prolongation. This risk may be increased if Strattera is used concomitantly with other drugs that produce QT prolongation, drugs that can cause electrolyte disturbances and those that inhibit cytochrome P450 2D6.

Reminder of previous advice

• Due to concerns about an increased risk of suicidal thoughts and behaviour, patients should be monitored for signs of depression, suicidal thoughts or suicidal behaviour and referred for appropriate treatment if necessary.

• There is a risk of rare, but sometimes severe, hepatic disorders. Strattera should be discontinued in patients with jaundice or laboratory evidence of liver injury, and should not be restarted.

The Strattera product information for prescribers (the Summary of Product Characteristics) and patients (the Patient Information Leaflet) are currently being updated to include appropriate warnings about the risk of seizures and QT interval prolongation.

Please report any suspected adverse reactions to Strattera via the Yellow Card Reporting Scheme to the CHM/MHRA

For further information please call the Medicines and Healthcare products Regulatory Agency on 020 7084 2000 or visit the website (www.mhra.gov.uk).

Yours sincerely,

Professor Gordon Duff
Chairman, Commission on Human Medicines

Attached documents:

  • Dear Doctor Letter - Strattera (atomoxetine) - Conclusions of risk:benefit review -16 February 2006
  • Strattera (atomoxetine) - question and answer document

Dear Doctor Letter - Strattera (atomoxetine) - Conclusions of risk:benefit review

UK MHRA – Medicines and Healthcare products Regulatory Agency -16 February 2006


MESSAGE FROM PROFESSOR G DUFF, CHAIRMAN, COMMISSION ON HUMAN MEDICINES.

16th February 2006 CEM/CMO/2006/

Dear Colleague,

Strattera(atomoxetine) – conclusions of risk:benefit review

I wrote to you in September 2005 to inform you about new evidence of an increased risk of suicidal thoughts or behaviour in association with the use of Strattera (atomoxetine). Strattera is authorised for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children of 6 years and older, and in adolescents, as part of a comprehensive treatment programme. It must be initiated by, or under the supervision of, a physician with appropriate knowledge and experience in treating ADHD.

Strattera has been marketed in the UK since July 2004 but has been available in the United States since November 2002. Worldwide exposure is estimated at 3.7 million patients as of November 2005. In light of the concern about the increased risk of suicidal thoughts and behaviour, a Europe wide review of available data on the risks and benefits of Strattera was initiated. This review has concluded that the overall balance of risks and benefits of Strattera remains positive in the treatment of ADHD in children of 6 years and older and in adolescents. However, in order to optimise the safe use of Strattera it is important that prescribers are aware of the following:

New Advice to prescribers

Seizures are a potential risk with Strattera and therefore it should be introduced with caution in patients with a history of seizure. Discontinuation of Strattera should be considered in any patient developing seizure or if there is an increase in seizure frequency.

Reports of QT interval prolongation have been received in association with Strattera.

Therefore, it should be used with caution in those with congenital or acquired long QT or a family history of QT prolongation. This risk may be increased if Strattera is used concomitantly with other drugs that produce QT prolongation, drugs that can cause electrolyte disturbances and those that inhibit cytochrome P450 2D6.

Reminder of previous advice

Due to concerns about an increased risk of suicidal thoughts and behaviour, patients should be monitored for signs of depression, suicidal thoughts or suicidal behaviour and referred for appropriate treatment if necessary.

There is a risk of rare, but sometimes severe, hepatic disorders. Strattera should be discontinued in patients with jaundice or laboratory evidence of liver injury, and should not be restarted.

The Strattera product information for prescribers (the Summary of Product Characteristics) and patients (the Patient Information Leaflet) are currently being updated to include appropriate warnings about the risk of seizures and QT interval prolongation.

Please report any suspected adverse reactions to Strattera via the Yellow Card Reporting

Scheme to the CHM/MHRA

For further information please call the Medicines and Healthcare products Regulatory Agency on 020 7084 2000 or visit the website (www.mhra.gov.uk).

Yours sincerely,

Professor Gordon Duff

Chairman, Commission on Human Medicines


Strattera (atomoxetine) - question and answer document

UK MHRA – Medicines and Healthcare products Regulatory Agency


Questions and Answers

Conclusions of European review of risks and benefits of Strattera (atomoxetine)

1. What is Strattera (atomoxetine)?

Strattera (atomoxetine) is a drug that can help control the symptoms of attention deficit hyperactivity disorder (ADHD - inability to pay attention and impulsiveness and hyperactivity) in children and adolescents.

Strattera is licensed for the treatment of ADHD in children of 6 years and older and in adolescents as part of a comprehensive treatment programme. Treatment must be initiated by or under the supervision of a doctor with appropriate knowledge and experience in treating ADHD.

2. How long has Strattera been on the market?

Strattera has been marketed in the UK since July 2004 but has been available in the United States since November 2002.

3. How many patients are taking Strattera in the UK?

It is estimated that up to 15,0000 patients have been treated with Strattera since it was marketed.

4. What is the issue?

New advice is being issued to doctors and the product information for doctors and patients is being updated following the completion of a Europe wide review of the risks and benefits of Strattera. This review has concluded that the benefits of Strattera in the treatment of ADHD in children of 6 years and older and in and adolescents outweigh the potential risks.

5. What advice is being given?

The Chairman of the Commission on Human Medicines (CHM) is writing to doctors to inform them of the outcome of this review and advise them of two newly identified risks - seizures (fits) and abnormal heart rhythm (QT interval prolongation). The letter also reminds doctors of the previously identified risks of liver damage and the potential for suicidal thoughts and behaviour in association with Strattera.

6. What is the new advice regarding seizures (fits)?

Doctors have been advised that Strattera is associated with a risk of seizure (fits). Careful consideration should be given to its use in patients with a history of seizures (fits) and continued use reviewed in patients who experience a seizure whilst on treatment.

If you or your child have ever suffered from a seizure (fit) you should discuss carefully with your doctor about whether Strattera is suitable for you/ your child as your risk of having a seizure may be increased.

7. What is the new advice regarding abnormal heart rhythm (QT interval prolongation)?

Due to concern about a risk of a particular heart rhythm abnormality known as QT interval prolongation, doctors have been advised that Strattera should be used with caution in certain patients and when used in combination with certain drugs (these include antidepressants such as fluoxetine, paroxetine sertraline and venlafaxine). Individuals with underlying problems relating to heart rhythm, namely congenital or acquired long QT, and those with a family history of QT prolongation may be at increased risk. If you are concerned or unsure whether this applies to you or your child you should discuss these concerns with your doctor.

8. What advice has previously been issued on suicidal thoughts and behaviour?

Doctors have been advised to monitor patients for signs of depression, suicidal thoughts or suicidal behaviour and refer them for appropriate treatment if necessary.

9. What advice has previously been issued on liver damage?

Doctors and patients have been informed of the risk of rare, but sometimes severe, liver disorders with Strattera. Treatment should be discontinued in patients with jaundice or laboratory evidence of liver injury, and should not be restarted.

10. Why was this European review conducted?

Strattera is recognised to cause some potentially serious side effects (for example liver damage and suicidal behaviour). Because of these side effects it was decided that a review of all available data should be carried out to find out if the benefits of using Strattera to treat children and adolescents with ADHD outweigh the risks of the side effects of the drug.

11. Is Strattera safe?

All medicines including Strattera and the other drugs available for the treatment of ADHD can cause side effects in some people.

We have sought advice on the safety of Strattera from experts on the Commission on Human Medicines (CHM) and a working group that included child and adolescent psychiatrists as well as lay representation. Based on the available evidence and since Strattera should only be initiated by or under the supervision of a specialist, the Commission considered that the benefits of taking Strattera for the treatment of ADHD outweigh the potential risks.

The conclusions of the UK CHM were endorsed in the subsequent European review.

12. Should I/ my child stop taking Strattera?

You/ Your child should not stop taking Strattera without talking to your doctor. If you or your child are feeling well you need not be concerned. Those who are concerned or unwell should consult their doctor to discuss the best course of action. It’s important that together you weigh up the possible risks of Strattera with the need to treat your/your child’s ADHD.

13. Are there alternatives to taking Strattera?

Methylphenidate and dexamphetamine are other drugs which are licensed for the treatment of ADHD in the UK.

Methylphenidate (trade names are Ritalin, Concerta XL and Equasym) is an amphetamine like drug which has been available in the UK for decades and was licensed as part of a comprehensive treatment programme for ADHD in children aged 6 years and older in 1988. Treatment should be under the supervision of a specialist in childhood behavioural disorders.

14. Do alternative treatments carry the same risks?

It is recognised that methylphenidate (trade names are Ritalin, Concerta XL and Equasym), another medicine licensed for the treatment of ADHD, can cause seizures (fits), liver problems, heart rate and rhythm abnormalities and may worsen an individual’s underlying depression.

15. Should I/ my child switch to another treatment?

No product is risk free. All medicines including Strattera and the other drugs available for the treatment of ADHD can cause side effects in some people. It should also be remembered that there are risks associated with untreated ADHD. If you have any concerns about you / your child’s treatment with Strattera you should discuss these with your doctor. Together you can and decide whether treatment with Strattera should be continued.

16. What should I do if I/my child suffer an adverse drug reaction on Strattera?

If you experience an adverse reaction while taking Strattera please consult your doctor, who is best placed to advise you on the most appropriate course of action.

17. Shouldn’t this drug be withdrawn from the UK market?

No. The efficacy of Strattera in helping control the symptoms of ADHD has been clearly shown and outweighs the risk of adverse effects from taking Strattera.

18. What does the MHRA do?

The MHRA is a Government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem.

In keeping with our aim to protect the public’s interests, the Agency also works to make sure that the public is kept informed and updated on the best scientific evidence and advice on drug safety issues.


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