Methylphenidate is a stimulant drug that is authorised in children over six years of age as part of a comprehensive treatment programme for attention deficit hyperactivity disorder. Treatment should be under the supervision of a specialist in childhood behavioural disorders. Its safety is closely monitored by the Medicines and Healthcare products Regulatory Agency in conjunction with other European regulatory authorities.
Stimulants such as methylphenidate are recognised to cause cardiovascular adverse effects such as tachycardia or palpitations, (increased or fast heart rate), arrhythmias (abnormal heart rhythm), changes in blood pressure (usually increased) and angina. There are warnings about these potential risks in the United Kingdom product information for methylphenidate, which also states that these products should not be used in patients with certain heart conditions.
Concerns have arisen about the risk of serious cardiovascular events (including sudden deaths) in association with stimulant treatment in children and adolescents with structural heart defects. Although it is recognised that some serious heart conditions alone carry an increased risk of sudden death, in the United States the Food and Drug Administration has requested that the product information for stimulant medications, including methylphenidate, be amended to reflect this risk and to advise that they should not be used in those with known serious structural cardiac abnormalities and also to strengthen warnings about the risk of other cardiovascular adverse effects.
The MHRA, with other European regulatory authorities, has also carefully evaluated the available data relating to the reports of sudden death in children with structural heart defects and taken into account the work of the United States FDA. As a result of these Europe-wide discussions, the product information for methylphenidate is being updated accordingly to advise about serious cardiovascular adverse effects and to recommend that methylphenidate should not be used in children or adolescents with known serious structural cardiac abnormalities. This will result in alignment of UK and European recommendations with those of the FDA.
Methylphenidate is only authorised for the treatment of attention deficit hyperactivity disorder in children aged six years and over and should only be initiated by or under the supervision of a specialist in childhood behavioural disorders. These restrictions on its use are clearly stated in the summary of product characteristics, which provides prescribing guidance to health care professional, and are also reflected in the British national formulary for children which is distributed on behalf of the Department to all general practices.