An ongoing FDA investigation of the side effects of Ritalin and other ADHD medications is raising concerns that the drugs may be linked to sudden, fatal heart problems in children.
In a statement issued on June 15, the FDA warns that a very limited study of the rate of death among children using stimulants to treat Attention-Deficit/Hyperactivity Disorder (ADHD) found that there may be an association with sudden death due to heart problems in healthy children. However, the FDA cautioned that parents should not stop their child’s medication based on the study.
The FDA noted that the study, which was funded by the National Institute of Mental Health and the FDA, had several limitations which make the data inconclusive. A larger, more focused, study is being funded by the FDA to specifically investigate if there is truly a link between heart problems and ADHD drugs like Ritalin, Concerta, Cylert and Dexedrine.
The study, which was published Monday in the American Journal of Psychiatry compared the use of ADHD drugs in 564 healthy children who died suddenly, most likely due to sudden cardiac problems, to the use of the drugs among 564 children who died in automobile accidents.
Although there was a low frequency of stimulant use reported in both the study group and the control group, the study 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.
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, healthcare professionals have warned of a 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. However, the new study raises concerns about a potential risk for children who were considered healthy.
The FDA advises parents not to take their children off the medications at this time, but to discuss any concerns with their child’s doctor.
There were several problems with the study’s methodology that could have skewed the findings, FDA said. First, the deaths occurred between 1985 and 1996, but the data on their medication was collected from 1997 to January 2008, leading to potential errors due to the time lag. Additionally, the FDA points out that the differences in the circumstances of the deaths may have accounted for differences in the family’s recall of what medications were being used, with a sudden unexplained death of a child being more likely to trigger an inquiry into the cause of death than a fatality suffered in an automobile accident.
These and other questions about the study have led the FDA and the Agency for Healthcare Research and Quality (AHRQ) to sponsor a large epidemiological study. The FDA estimates that data collection for the new study will be available later this year.