- Medicines and Healthcare products Regulatory Agency
- Therapeutic area:
- Paediatrics and neonatology and Psychiatry
The design and content of the Patient Information Leaflets for methylphenidate products are being updated with the latest guidance on safe and effective use for patients and carers
Article date: January 2010
Methylphenidate is a stimulant treatment for children aged 6 years or older and adolescents with attention-deficit hyperactivity disorder (ADHD).
The design and content of the Patient Information Leaflets for methylphenidate products are being updated with the latest guidance on safe and effective use for patients and carers.
This includes a tear-off section for children and adolescents who are taking methylphenidate. This tear-off section includes the most important messages written in an engaging style for children and adolescents. The leaflets have been tested with adults, children, and adolescents, and the key messages for safe use have been readily found and easily understood. Youngsters very much appreciated having their own specially drafted section. Examples of these leaflets can be found here.
Reminder for healthcare professionals to support safer use of methylphenidate
Updated guidance from MHRA on the safer use of methylphenidate recommends that patients should have careful ongoing monitoring during treatment and that the need for long-term treatment is re-evaluated at least yearly.
The product information for prescribers of methylphenidate has recently been updated with guidance to support safer use of:
- treatment with methylphenidate should be supervised by a specialist in childhood or adolescent behavioural disorders
- dagnosis being made according to DSM-IV (Diagnostic and statistical Manual of Mental Disorders, 4th edition) criteria or ICD-10 (International Classification of Diseases 10th revision) guideline, and should be based on a complete history and evaluation and not solely on the presence of one or more symptom(s)
- ensuring children and adolescents having rigorous pretreatment screening, including a complete history and relevant examination (including psychiatric disorders or symptoms, cardiovascular status, height, and weight)
- patient being monitored regularly during methylphenidate treatment, including: blood pressure and pulse; height, weight, and appetite; onset or worsening of psychiatric symptoms (such as depression, suicidal thoughts, hostility, anxiety, agitation, psychosis, or mania); and symptoms suggestive of heart disease (which should prompt specialist cardiac evaluation)
- treatment being interrupted at least yearly to determine whether continuation is needed
Studies of cytogenetic effect of methylphenidate
In 2005, a small study1 suggested significant damage to chromosomes in children with ADHD treated with methylphenidate. The study had important methodological limitations that reduced its reliability. 2 3 Concerns about the potential for methylphenidate to cause genetic damage and cancer prompted several further in vitro, in vivo, human, and pharmacoepidemiological studies investigating this issue. 4 5 6 7 8 9
These important new studies have been assessed and included in a review by MHRA of all relevant data on this issue to date. Most of the in vitro and in vivo studies did not show any clear evidence of the potential for methylphenidate to increase the risk of mutations, cause malignancies, or cause chromosomal damage that can lead to the formation of cancers. Importantly, several further studies4–6,8 of humans after the initial El-Zein study1 with improved design all failed to replicate the preliminary findings: they did not show any chromosomal damage associated with methylphenidate treatment for ADHD.
The Commission on Human Medicines advised on the review, concluding that overall there is no strong evidence from a range of data sources that methylphenidate causes chromosomal damage, and that the evidence provides no clear basis for suspecting an increased risk of cancer with this treatment.
The benefits of methylphenidate continue to outweigh the risks when used to treat ADHD in children aged 6 years or older and adolescents. The longer-term safety of methylphenidate remains under close review, and the results of ongoing studies to characterise the known or potential risks of ADHD medicines will be evaluated when available.
Further information on methylphenidate is available in the March 2009 issue of Drug Safety Update.
Article citation: Drug Safety Update Jan 2010, vol 3 issue 6: 5.
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