European Medicines Agency Makes Recommendations For Safer Use Of Ritalin and Other Methylphenidate-containing Medicines In The EU

The European Medicines Agency (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 (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 (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 minimization
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.


Notes


1. More information is available in a
question-and-answer document.


2. Medicines containing methylphenidate are available in all EU Member
States.


3. The review was initiated by the European Commission under Article 31
of Directive 2001/83/EC, as amended, on the basis that some safety
concerns, including cardiovascular and cerebrovascular diseases,
potentially associated with methylphenidate treatment should be
evaluated at Community level. An Article 31 referral may be initiated in
specific cases where the interest of the Community is involved. The
expression 'Community interest' has a broad meaning but it refers
particularly to the interests of the public health in the Community, for
example following concerns related to the quality, efficacy and/or
safety of a medicinal product or new pharmacovigilance information.
4. Some methylphenidate-containing medicines can also be used to treat
narcolepsy in adults, but this indication has not been assessed in this
review.


5. This press release, together with other information about the work of
the EMEA, may be found on the EMEA web site at
emea.europa.eu.

EMEA


View drug information on Concerta; Ritalin LA.