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FDA Panel Recommends "Black Box" Warnings on ADHD drugs


On Thursday, February 9, 2006, an advisory committee to the U.S. Food and Drug Administration (FDA) urged the most serious FDA warning, the “black box”, be placed on all drugs prescribed to treat the so-called psychiatric disorder Attention Deficit Hyperactivity Disorder (ADHD).  The recommendation followed evidence that these drugs are linked to deaths and cardiovascular problems such as heart attacks and strokes. 

The FDA’s database documents 25 deaths and 54 cases of serious cardiovascular problems in children and adults treated with ADHD drugs.

These cases included heart attack, stroke (sudden loss of brain function), hypertension (high blood pressure), palpitations (rapid, strong heart beats) and arrhythmia (irregular heart beats). 

Experts estimate that only 1% to 10% of serious drug reactions are reported to the FDA, so the deaths and serious adverse effects are undoubtedly much higher. 

There are six million U.S. children who have been prescribed ADHD drugs including Ritalin, Adderall and Concerta.  Government figures show that about 10% of all 10-year-old boys in the U.S. are on these drugs.  Prescriptions of ADHD drugs for adults has increased 90% in the last three years.

The advisory committee’s recommendation for the “black box” warning took FDA officials by surprise.  The committee’s original purpose was only to recommend ways to study the effects of ADHD drugs.  However, after reviewing the deadly effects of the drugs, the committee urged immediate action.

Peter Gross, chairman of the advisory committee, stated the reason for the recommended warnings were, "No. 1, because of the seriousness of the side effects – the sudden deaths. No. 2, there is a sense maybe the diagnosis of ADHD is being applied where it shouldn't be applied."

Advisory committee member Dr. Steven Nissen, a cardiologist, explained the urgency, "This is out-of-control use of drugs that have profound cardiovascular consequences.  We have got a potential public health crisis. I think patients and families need to be made aware of these concerns." 

Over 350 news outlets are now running this story internationally including: 

the front pages of the Los Angeles Times and New York Times; USA Today, Boston Globe, Washington Post, Chicago Tribune, Miami Herald, Houston Chronicle, San Francisco Chronicle, Tapei Times, The Australian, Reuters UK and United Press International and Associated Press.

Click here to read the LA Times article

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