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FDA Panel Recommends “Clearer” Labels on ADHD ADD Drugs Today – Last Month Another Panel Recommended “Black Box” Warnings On Ritalin and Adderall

March 22nd 2006

FDA Panel Recommends “Clearer” Labels on ADHD ADD Drugs Today – Last Month Another Panel Recommended “Black Box” Warnings On Ritalin and Adderall

Clearer Labels Recommended

A Food and Drug Administration (FDA) pediatric advisory panel recommended strong warnings on drugs used to treat attention deficit disorder (ADD) today, but stopped short of the black-box warnings recommended by another FDA advisory panel on drug safety last month. The panel heard about cases in which children experienced frightening hallucinations while using the medications.  These hallucinations often involved bugs and snakes.

The panel heard from psychiatrists and other experts that these drugs fill a critical need for treating mental health problems in children, and they feared the black box warnings would scare patients away from treatment.  The black-box warnings are the strongest warnings issued by the FDA.

There have been concerns about heart attack and stroke since most of the medications are stimulants and raise blood pressure.  Ricardo Alonso-Zaldivar wrote in the LA Times that “Members of the pediatrics committee said such a drastic warning is not needed for children, since they have a very low overall risk of heart problems.”  The committee said that children with heart problems should not take the drugs.


The drug manufactures say that the risk is low for serious side effects.  Their data show that the rates for heart problems, hallucinations, and aggressive behavior are essentially the same as those in the general population. 

The FDA usually follows through with their advisory panel’s guidelines, but in this case there is a conflict.  Both panels do agree that patients and doctors need to be educated about the hazards of the drugs.  Last month the panel presented evidence of the heart risks, but added more studies are needed to confirm this risk.

The FDA reviewers were surprised at the number of hallucination reports.  According to reports, these hallucinations usually went away after the patients quit using the drugs.  Some of the drug manufacturers said that the children could have had underlying psychiatric problems that emerged when their ADHD was brought under control by the drugs.    


Some news reports said the FDA recommended stronger or tougher warnings.  According to a report on ABC News, panel chair Dr. Robert Nelson said “I wouldn't use the word 'tougher’.  Clearer”.  Wednesday’s panel believes the labels should be rewritten.      

A prescription drug benefit program, Medco Health Solutions Inc., says there are nearly 3.3 million Americans under the age of 20 that used ADHD drugs last year.  These drugs include Ritalin, Adderall and Strattera. 

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By Dan Wilson
Best Syndication

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Keywords and Misspellings: ADD ADHD attention deficit disorder atention defecit attension dissorder

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Copyright 2005 Best Syndication                                            Last Updated Saturday, July 10, 2010 09:50 PM