On April 21, 2008 the American Heart Association surprised the medical world by recommending that all children currently taking ADHD stimulant drugs or who are being considered for the treatment be given an EKG (electro-cardiogram) and have a complete history taken of all family history of heart problems. The recommendation was made because of known risks to children with congenital heart disease, such as obstructive cardiomyopathy, who take stimulant drugs that increase heart rates. Since these congenital heart conditions may be undiagnosed, the American Heart Association recommends a basic screening for heart risk that involves a relatively inexpensive procedure. The dangers of using stimulants with some congenital heart conditions is well known and undisputed. The Association cited evidence that these heart conditions are often undiagnosed. Dr. Victoria Vettter, who specializes in cardiology for children at the University of Pennsylvania School of Medicine headed the committee that made the recommendation. She reported that she had been doing these screenings for 3 years, and out of 1,100 children screened, approximately 2% had some kind of previously undiagnosed heart problem.

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The American Heart Association’s recommendations are consistent with prior information provided by the FDA (Food and Drug Administration). In 2006 the FDA released a study that 25 children and adults (19 of them children) had suffered sudden death after taking ADHD stimulant drugs from 1999 to 2003. The FDA also reported 54 cases of other very serious cardiovascular problems. In response a committee meeting on February 6, 2006 suggested a black box warning, the most serious level of warning for any drug allowed on the market, for the dangers of sudden death and other cardiac problems. Another committee disagreed in a March 26, 2006 meeting and recommended a less serious warning. The manufacturer of Dexedrine decided to place a black box warning on that drug in August 2006. The FDA told the remaining ADHD stimulant drug manufacturers to include a stronger warning, but did not require black box warnings. The FDA required these new warnings in August 2006; 6 months later the warnings had not been added and the FDA issued a second request. The new warnings were finally added to materials parents could read close to a year after the FDA first published the reports of several deaths.

Despite the reasonableness of the American Heart Association’s recommendation for more care in prescribing stimulant drugs, doctors who are financially tied to the manufacturers of ADHD drugs immediately protested the recommendation, claiming that requiring the screening would deter parents from giving the drugs to their children.

Some of the researchers who protested the AHA's recommendations include a Harvard team known for their controversial advocacy of off-label prescriptions of psychiatric drugs to children for conditions including ADHD and the psychiatric symptoms that might be created by ADHD drugs. Off-label prescribing means prescribing drugs that have not been tested for safety or effectiveness for the patient in question. Some psychiatric drugs, for example, are approved only for use in adults, since they may have different effects on children. It is legal for a doctor to prescribe off label, but illegal for a pharmaceutical company to urge them to do it. When researchers who are paid millions by drug companies urge doctors to use these untested drugs on children, this raises serious issues. If a child dies or is seriously injured by the drug use, the treating physician can claim there was no malpractice because a prominent Harvard researcher advocated using the drug, and so the doctor’s decision was reasonable. In this conflict of interest shuffle, the lives and well being of children are at stake.

An even greater danger to children may lie in the use of very powerful antipsychotic drugs to treat symptoms of ADHD. A Florida study of the Medicaid program showed that 40% of the antipsychotic drugs prescribed to children were for ADHD, though none of the drugs are approved by the FDA for the treatment of ADHD. Researchers at Harvard have been instrumental in promoting this off-label use, even with very small infants. The fact that doctors have been willing to prescribe extremely strong drugs with serious side effects to tiny infants without FDA approval or testing for safety and effectiveness raises serious ethical and professional questions all parents should know about.