FDA Panel Recommends
“Clearer” Labels on ADHD ADD Drugs Today – Last Month Another Panel
Recommended “Black Box” Warnings On Ritalin and Adderall
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
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
By Dan Wilson
Books on ADHD
Keywords and Misspellings: ADD ADHD attention deficit
disorder atention defecit attension dissorder