News and Educations

No change on safety profile of stimulant medication used in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD)


The U.S. Food and Drug Administration (FDA) reported that no conclusions can be drawn regarding the change of the safety profile of this class of medicinal products from the results of the recently published study which, based on 10 cases, established an association between sudden death and the use of stimulant medications to treat children and adolescents with ADHD.

The study, published in The American Journal of Psychiatry on 15 June 2009, is a retrospective study of pairs based on death data (vital statistics). 560 children aged between 7 and 19 who died suddenly (most probably of cardiovascular causes) and the identical number of children who died in traffic accidents have been compared. By examining the toxicological analyses of samples taken at autopsy, it was observed that 10 children who died suddenly and 2 children who died in traffic accidents had traces of stimulant medications in their blood. The link between a sudden death and use of psychostimulants proved to be statistically significant. Despite such statistical significance, the study has a number of limitations and its results cannot serve as a basis for conclusions about the change of the benefit/risk ratio of this class of medicinal products for use in children and adolescents.

Parents are advised not to discontinue the therapy with stimulant medications in children with ADHD, and physicians to adhere to the approved Summary of Product Characteristics, and prior to introduction of therapy with psychostimulants, to take a detailed medical history of each child and examine their cardiovascular system.

In Croatia, among the stimulants for ADHD treatment, the approved medicinal product is Concerta (metilphenidate). This medicinal product is approved for treatment of children older than 6 years of age, and the marketed dosages are 18 mg and 36 mg. Since 2007, only one batch of any individual dosage has been released in the market. The medicinal product is not on the HZZO list. As for the psyschostimulant medicinal products included in the above study which do not have a marketing authorisation for Croatia, the Agency for Medicinal Products and Medical Device has so far issued an import approval for 25 packagings of the medicinal product Strattera (atomoxetine).

No adverse event associated with the medicinal product Concerta has been reported in Croatia. The Agency for Medicinal Products and Medical Devices will continue to monitor the safety of psychostimulants in the treatment of ADHD and to report on all new safety information.

The FDA press release can be found here.
The entire article published in The American Journal of Psychiatry on 15 June 2009 can be found here.