The risk of cardiovascular adverse reactions from methylphenidate

Methylphenidate, (Equasym®, Motiron® and Ritalin®) must not be prescribed for patients with cardiovascular disorders, cardiac arrhythmia or severe hypertension.

The website of the American Food and Drug Administration (FDA) informs about the risk of serious adverse reactions, such as increasing blood pressure, myocardial infarctions and strokes, from treatment with central nervous system stimulants for treatment of attention deficit hyperactivity disorder (ADHD) in children. The FDA considers introducing a so-called “black box warning” to make the risks more apparent to patients.

In Denmark , three products containing central nervous system stimulants for treatment of ADHD are authorised. All of them contain the active substance methylphenidate (Equasym®, Motiron® and Ritalin®).

The Danish Medicines Agency would like to point out that methylphenidate is contraindicated for patients with cardiac arrhythmia and severe angina pectoris. The summaries of product characteristics specify that the blood pressure should be monitored with regular intervals in patients treated with methylphenidate, and especially in patients with hypertension. In Denmark , methylphenidate is primarily used for children aged 6-15, who have a small risk of heart disease and hypertension. In the fact box to the right, you can find a link to the article on the FDA’s website.

The Danish Medicines Agency’s adverse reaction database contains 10 reports on adverse reactions, such as cardiac arrhythmia and effect on blood pressure. None of these adverse reaction reports are about deaths.

For further information, please contact Doris Irene Stenver on dis@dkma.dk or on tel.: +45 4488 9247.

The Danish Medicines Agency, 14 February 2006