EMEA reviewed methylphenidate (Ritalin) for ADHD and issued recommendations for its safer use

EMEA’s Committee for Medicinal Products for Human Use (CHMP) has reviewed methylphenidate for attention deficit/hyperactivity disorder (ADHD). Quoting the press release issued 22 January 2009:

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.

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.

Brand names for methylphenidate include: Ritalin, Ritalina, Rilatine, Attenta (in Australia), Methylin, Penid, and Rubifen; and the sustained release tablets Concerta, Metadate CD, Methylin ER, Ritalin LA, and Ritalin-SR.

Source: Press Release – European Medicines Agency makes recommendations for safer use of Ritalin and other methylphenidate-containing medicines in the EU

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