The findings of a new study failed to find any correlation between the potential side effects of Ritalin, Adderall and other Attention-Deficit/Hyperactivity Disorder (ADHD) medications and an increased risk of death in children.
The study, published online this week by the medical journal Pediatrics, contradicts findings of a 2009 study by the National Institute of Mental Health, which first raised concerns about a risk of sudden death from heart problems in otherwise healthy children treated with ADHD medications. FDA has been investigating the possibility of such a link since the 2009 report.
Researchers from the University of Pennsylvania looked at two databases covering all children ages 3 to 17 with prescriptions to ADHD drugs. They found that there was no statistically significant difference between the mortality rate due to heart problems of children who were taking ADHD and those who were not. They also looked at deaths from strokes and the mortality rates in general and found no statistically significant differences.
ADHD medications are used by nearly 3.3 million American children under the age of 20. Some estimates have placed usage of ADHD drugs as high as 10% among 10 year old American boys, and many experts believe that the drugs are often prescribed to individuals for whom the benefits do not outweigh the risks associated with the medications.
For years, some experts have been warning about a potential link between stimulant drugs meant to treat ADHD, such as Concerta, Adderal XR, and Ritalin, and heart problems like cardiac arrest.
In 2007, mounting evidence led the FDA to require more stringent warning labels on the medications, highlighting the possible link between ADHD drugs and increased blood pressure, rapid heart rate, and risk of sudden death for those with cardiovascular problems. The FDA launched a safety review of the drugs following the 2009 study, which compared the rate of cardiac death among ADHD drug users to auto fatalities among nonusers and found that 10 children who died from problems like sudden cardiac disturbance were taking the drugs, compared with only two who died in a motor vehicle accident.