EU Medicines Agency Recommends Safer Use Of Ritalin
January 22 2009 - 11:40AM
Dow Jones News
The European Medicines Agency, or EMEA, has concluded that
methylphenidate-containing medicines remain suitable for the
treatment of children aged six years or older and adolescents with
attention deficit/hyperactivity disorder, or ADHD.
It has also recommended that the product information be made
consistent across the European Union (EU) so that all patients,
carers and prescribers have the same information for safer and more
appropriate use of these medicines.
Methylphenidate has been available in the EU since the 1950s
under various trade names, including Ritalin, Concerta, Equasym,
Medikinet and Rubifen. In ADHD, it is used as part of a
comprehensive treatment programme that includes psychological,
educational and social interventions, when other measures have not
been effective in changing behaviour.
The EMEA's Committee for Medicinal Products for Human Use, or
CHMP, has reviewed methylphenidate due to concerns over
cardiovascular risks (hypertension, heart rate increases and
arrhythmias) and cerebrovascular risks (migraine, cerebrovascular
accident, stroke, cerebral infarction cerebral vasculitis and
cerebral ischaemia). In addition to these concerns, CHMP looked at
the risk of psychiatric disorders, the effect of methylphenidate on
growth and sexual maturation, and the effects of long-term
treatment.
Following review of the available data, the Committee concluded
that there was no need for an urgent restriction to the use of
methylphenidate-containing medicines, but that new recommendations
on prescribing the medicines and on pre-treatment screening and
ongoing monitoring of patients are needed to maximise the safe use
of these medicines.
Because information about their safety is not consistent across
the EU, the CHMP concluded that the product information of all
methylphenidate-containing medicines authorised in the Member
States should contain the following information:
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;
There is a lack of information on the long-term effects of
methylphenidate. 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;
The use of methylphenidate could cause or worsen some
psychiatric disorders such as depression, suicidal thoughts,
hostility, psychosis and mania. All patients should be carefully
screened for these 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.
In addition, the CHMP also asked that further risk minimisation
measures, including educational material for doctors, be put in
place and that further studies be carried out, particularly into
the long-term effects of methylphenidate.
The CHMP opinion has now been sent to the European Commission
for the adoption of a legally binding decision, applicable in all
EU countries.
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