Ask Us
Safety Alert: Methylphenidate
MHRA Review of METHYLPHENIDATE and Risk of Genetic Damage and Update to Patient Information Leaflet
What does this mean?
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.
This safety alert is also a good reminder to all patients taking METHYLPHENIDATE and parents who care for children who take METHYLPHENIDATE to review the risks and benefits of treatment with your healthcare provider annually.
You can review some examples of the updated Patient Information Leaflets at these weblinks:
Concerta XL 18 mg: http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON068247&RevisionSelectionMethod=Latest
Concerta XL 27 mg: http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON068248&RevisionSelectionMethod=Latest
Ritalin: http://www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON068246&RevisionSelectionMethod=Latest
If you have any questions about this safety alert or if you have concerns about side effects from METHYLPHENIDATE (or its brand name products), please follow up with your doctor or other healthcare provider.
The January 2010 Drug Safety Update from the MHRA reports that the Commission on Human Medicines has finished its review of the data surrounding the concerns about the potential for METHYLPHENIDATE to cause genetic damage and cancer. Overall, there is no strong evidence that METHYLPHENIDATE causes chromosome damage, and the current evidence provides no clear basis for suspecting an increased risk of cancer with this treatment.
The MHRA also describes an update to the Patient Information Leaflets for METHYLPHENIDATE products, along with a reminder to healthcare professionals to support safer use. The new Patient Information Leaflets contain the latest information on safe and effective use for patients and carers and will include a tear-off section for children and adolescents who are taking METHYLPHENIDATE. This tear-off section includes the most important messages written in a style for children and adolescents.
To support safer use, the METHYLPHENIDATE product information for doctors and other prescribers has been updated with the following guidelines:
1) Treatment with METHYLPHENIDATE should be supervised by a specialist in childhood or adolescent behavioural disorders,
2) ADHD Diagnosis should be made according to accepted guidelines, such as DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition) criteria or ICD-10 (International Classification of Diseases 10th revision),
3) Children and adolescents should have rigorous pre-treatment screening, including a complete history and relevant examination (including psychiatric disorders or symptoms, cardiovascular status, height, and weight),
4) Patients should be 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),
5) Treatment should be interrupted at least yearly to determine whether continuation is needed.
METHYLPHENIDATE is a stimulant treatment for children aged 6 years or older and adolescents with attention-deficit hyperactivity disorder (ADHD) and other behavioural problems. It is also marketed under the names CONCERTA XL, EQUASYM, EQUASYM XL, MEDIKINET, MEDIKINET XL, and RITALIN.
For more information, please visit:
