NPC Archive Item: EMEA recommendations for safer use of methylphenidate-containing medicines

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4th February 2009

The EMEA’s Committee for Medicinal Products for Human Use (CHMP) has reviewed methylphenidate due to concerns over cardiovascular and cerebrovascular risks. They also considered the risk of psychiatric disorders, the effects on growth and sexual maturation, as well as the effects of long-term treatment. The Committee concluded that methylphenidate-containing medicines remain suitable for the treatment of children aged six years or older and adolescents with attention deficit/hyperactivity disorder (ADHD). However, in order to maximise the safe use of these medicines, product information should contain new information on prescribing, pre-treatment screening and ongoing monitoring of patients.

The CHMP recommends that:

  • Before treatment, all patients should be screened to see if they have any problems with their blood pressure or heart rate. The family history of cardiovascular problems should also be checked. Any patients with these problems should not be treated without specialist evaluation.
  • During treatment, blood pressure and heart rate should be monitored regularly. Any problems that develop should be investigated promptly.
  • For patients who take methylphenidate for more than a year, doctors should interrupt treatment at least once a year to determine whether continued treatment with methylphenidate is necessary.
  • All patients should be carefully screened for psychiatric disorders before treatment and monitored regularly for psychiatric symptoms during treatment.
  • The height and weight of patients treated with methylphenidate should be monitored during treatment.

What is the background to this?
The CHMP review focussed on the cardiovascular risks (hypertension, heart rate increases and arrhythmias) and cerebrovascular risks (migraine, cerebrovascular accident, stroke, cerebral infarction, cerebral vasculitis and cerebral ischaemia) associated with methylphenidate treatment. In addition, it considered whether there is any evidence for a link between methylphenidate and psychiatric problems, reduced growth and sexual maturation, and looked at information on the long-term effects of treatment.

What did the review discover?
The CHMP concluded that there was no need for an urgent restriction to the use of methylphenidate-containing medicines and that the benefits of these medicines continue to outweigh their risks, when they are used in their approved indication for children aged six years or over and adolescents with ADHD, as part of comprehensive treatment programmes. However, it concluded that new recommendations on prescribing these medicines and on pre-treatment screening and ongoing monitoring of patients are needed to maximise their safe uses.

How does this fit with NICE guidance?
As we have previously blogged, NICE issued guidance on the diagnosis and management of ADHD in children, young people and adults in September 2008. NICE advise that drug treatment should be offered as the first-line treatment in school-age children and young people with severe ADHD and in adults with ADHD. Drug treatment should always form part of a comprehensive treatment programme that addresses psychological, behavioural and educational or occupational needs. Methylphenidate should normally be tried first. However, it is not currently licensed for use in adults.

The recommendations made by the CHMP are in accordance with NICE guidance. NICE advises that, before starting drug treatment, children, young people and adults with ADHD should have a full assessment, which should include:

  • Full mental health and social assessment.
  • Full history and physical examination, including:
    – assessment of history of exercise syncope, undue breathlessness and other cardiovascular symptoms.
    – heart rate and blood pressure (plotted on a centile chart).

    – weight (plus height in children and young people, both plotted on a growth chart)

    – family history of cardiac disease and examination of the cardiovascular system.

  • An electrocardiogram (ECG) if there is past medical or family history of serious cardiac disease, a history of sudden death in young family members or abnormal findings on cardiac examination.
  • Risk assessment for substance misuse and drug diversion.

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