The FDA Announces Label Changes for Ritalin and Dexedrine
Aug 2006
 Two of the most popular stimulants used to treat ADHD are going to be receiving changes to their labels to include a warning of a risk of heart problems and psychotic behavior, according to an FDA announcement.
The FDA has received reports of sudden death among children and teens who had heart problems and took Dexedrine. Any stimulant is potentially dangerous for someone with a heart condition, and most of the time a child, or teen, does not have his heart checked by a physician before he is prescribed a stimulant for ADHD.
The FDA says the new warning was announced as a result of new information it has received.
GlaxoSmithKline, the makers of Dexedrine, recently announced the new labelling. The company warned physicians (and parents) that there have been cases of sudden death, myocardial infarction and strokes among adult patients talking Dexedrine at normal doses.
There are also risks for patients with existing psychotic disorders when they take these drugs, such as delusional thinking, hallucinations and aggression.
Whether or not other drugs, such as Concerta (Johnson & Johnson) and Strattera (Eli Lilly) will also have to have new labels remains to be seen.
This newsletter reported earlier in detail that two separate FDA panels of experts had conflicting opinions on whether these drugs warranted a ‘black box' warning - the strongest possible label warning. As a result of this disagreement, it has taken the FDA a number of months to come to a decision. See our March 31 article: Parents and ADHD Patients Caught in the Middle as FDA Committees Disagree for background information.
Editor: I have never been opposed to the use of Ritalin or Dexedrine, or other medications for ADHD, even though I helped to develop Attend as an alternative to these medications. I recommend Attend, and I sell it through the web site. But I have seen over 900 children, teens, and adults benefit from the use of stimulants for the treatment of ADHD, so I have never "bad mouthed" medications as a treatment. I have only offered Attend, diet, and biofeedback as other choices to consider, and warned that stimulants must be used carefully if used at all. But I have to admit that with these FDA hearings I am "coming close" to "rethinking" my position on these medications. I guess I'm not quite there yet, but the evidence is starting to make me a bit more uncertain of my position.
So for now, I'll still recommend making sure the diagnosis is accurate, ruling out allergies or environmental toxins, ruling out depression or bipolar disorder. Then trying our diet, and 45 days of Attend, to see if they will do the job. If they don't work, then consider a trial of medication - but used carefully.
Doug Cowan, Psy.D.
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