Article date: March 2009
The European Medicines Agency (EMA) has completed a review of the benefits and risks of methylphenidate after recent concerns about its cardiovascular, cerebrovascular, and psychiatric safety and its long-term effects.
The EMA’s Committee for Medicinal Products for Human Use concluded that on the basis of currently available data, the benefits of methylphenidate continue to outweigh the risks when used in its licensed indication. Methylphenidate is indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in children aged 6 years or older and adolescents, who are diagnosed according to DSM-IV criteria or guidelines in ICD-10 and when remedial measures alone are insufficient.
European Medicines Agency makes recommendations for safer use of ritalin and other methylphenidate-containing medicines in the EU on their website. Also see some answers on the review of medicines containing methylphenidate.
See the recommended elements to include in summaries of product characteristics for methylphenidate-containing medicinal products authorised for the treatment of ADHD in children aged 6 years and above as well as adolescents.
For more information on brands of methylphenidate available in the UK, see the British National Formulary (BNF).
$CTA Contraindications—methylphenidate should not be used in patients with:
- diagnosis or history of severe depression, anorexia nervosa or anorexic disorders, suicidal tendencies, psychotic symptoms, mania, schizophrenia, severe mood disorders, or psychopathic or borderline personality disorder
- diagnosis or history of severe and episodic (type I) bipolar (affective) disorder that is not well-controlled
- pre-existing cerebrovascular disorders—eg, cerebral aneurysm and vascular abnormalities, including vasculitis or stroke
- unless specialist cardiac advice has been obtained: in pre-existing cardiovascular disorders, including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias, and dysfunction of cardiac ion channels
For pretreatment screening, you should:
- assess the patient’s baseline cardiovascular status, including blood pressure and heart rate before prescribing
- carry out a complete history, documenting concomitant medicines, past and present medical and psychiatric disorders or symptoms, family history of sudden cardiac death, unexplained death, or malignant arrhythmia and accurate pretreatment height and weight on a growth chart - patients who are being considered for treatment with methylphenidate should also have a physical examination for the presence of heart disease
- provide patients with specialist cardiac evaluation if findings suggest such history or disease - caution should be used when treating patients whose underlying medical conditions might be compromised by increased blood pressure or heart rate
For ongoing monitoring you should:
- record the blood pressure and pulse on a centile chart at every dose adjustment and then at least every 6 months
- record the height, weight, and appetite at least every 6 months on a growth chart
- monitor development or worsening of pre-existing, psychiatric symptoms at every dose adjustment and then at least every 6 months, and at every visit - ethylphenidate could cause or worsen some psychiatric disorders such as depression, suicidal thoughts, hostility, anxiety, agitation, psychosis, and mania
- look out for signs of diversion (transfer of the medicine from the individual for whom it was prescribed to one for whom it is not prescribed), misuse, and abuse of methylphenidate
- carry out a prompt cardiac evaluation for patients who develop symptoms such as palpitations, exertional chest pain, unexplained syncope, dyspnoea, or other symptoms suggestive of heart disease during methylphenidate treatment
There is a lack of data on the long-term effects of methylphenidate. For patients who take methylphenidate for extended periods (ie, >1 year), physicians should periodically interrupt treatment at least once a year to determine whether continuation is necessary. The longer-term safety of methylphenidate remains under close review, and the results of ongoing studies to better characterise the known or potential risks of ADHD medicines will be evaluated when available.
Guidance from National Institute for Health and Care Excellence (NICE)
NICE recommends that drug treatment should be offered as a first-line treatment in severe ADHD and severe impairment in school-age children and young people.
Article citation: Drug Safety Update March 2009, vol 2 issue 8: 2