Is Sudden Death of Children a Risk in ADHD Drugs?

Washington, DCThe jury is still out as to whether or not an ADHD drug could be viewed as a defective drug due to concerns with regard to the potential for sudden death in some children. A drug defect in this context has yet to be proven and drugs need not be labeled as defective medical products if the risk has not been nailed down.

However concern remains, thanks in part to a new study funded by the National Institute of Mental Health and the US Food and Drug Administration (FDA). The study, which will appear in The American Journal of Psychiatry and was posted online June 15th, suggests that children and teens who take drugs such as Ritalin to combat the effects of ADHD have an increased risk for sudden cardiac death.

The FDA is quick to point out that there are limitations with the study and that the real risk for cardiac death is quite small.

According to WebMD the FDA had this to say in a statement: "Given the limitations of this study's methodology, the FDA is unable to conclude that these data affect the overall risk-and-benefit profile of stimulant medications used to treat ADHD in children.

The FDA maintains that information on stimulant use was assembled years and in some cases ten years or more after the children from whom the data was collected, had passed on.

That said, WebMD reports that the study does, indeed provide corroborating evidence to support a long-standing concern over the potential for cardiac death.

According to the study, researchers collected data on stimulant use among 564 children and teenagers who died unexpectedly of unknown causes, together with an equal number who died as passengers in automotive accidents. It should be noted that many of the unexplained deaths were later attributed to previously undiagnosed cardiac arrhythmias.

The researchers concluded that the odds of using stimulant medication were six to seven times greater among the children who died suddenly of unexplained causes, than among those who died in car crashes.

Ten children who died of unknown causes (a tad under 2%) took stimulants, compared to two children (0.4%) who died in auto accidents.

Thus, the study does not prove that ADHD drugs cause cardiac deaths. But lead researcher Madelyn S. Gould, PhD commented to WebMD that the results suceeded in highlighting the importance of carefully screening children and teens for heart conditions when such medications are prescribed.

In an editorial published in concert with the study, Benedetto Vitiello MD, and Kenneth Towbin, MD of the National Institute of Mental Health wrote that the report "should underscore that stimulants are not innocuous and that their therapeutic use requires careful diagnostic assessment, diligent safety screening and ongoing monitoring."

It is estimated that more than 2.5 million children and teens in the United States take stimulants to control their ADHD.

According to the June 15th WebMD posting an FDA panel reported in March 2006 that between 1992 and 2005, 11 sudden cardiac deaths occurred in children taking Ritalin and Concerta, which both contain the stimulant methylphenidate and 13 sudden cardiac deaths occurred among children taking the amphetamine-containing stimulants Adderall and Dexedrine. Three sudden cardiac deaths were also reported among children taking the ADHD drug Strattera, which is not a stimulant.

Late last year, a special panel of the American Heart Association recommended screening all children and teens taking ADHD drugs for hidden heart problems. At the same time the panel also called for electrocardiogram (ECG) screening of all patients being placed on the stimulants for the first time.

A more recent concern appears to be that Ritalin, Concerta and other ADHD drugs are increasingly being used to boost academic or job performance, rather than for sound medical purposes.

Vitiello commented to WebMD that recreational users mistakenly think of these drugs as safe, but "these drugs are being widely misused and people need to know that they are not benign."

Can an ADHD drug be called a defective drug? It's still too early to tell. Additional research is in the works, research that will hopefully shed a more conclusive light on ADHD drugs in the months to come. Only then can a drug defect be proven in association with defective medical products. In the meantime, caution is the watchword.