ADHD Drug Label Changes Announced By FDA

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ADHD Drug Label Changes Announced By FDA
Date: 22 Aug 2006 - 8:00am (PDT)


Dexedrine and Ritalin are drugs used to treat ADHD (attention-deficit
hyperactivity disorder). The FDA announced changes to their labels, and
possibly those of some other ADHD drugs, to include a warning of a risk of
heart problems and psychotic behaviour.

The FDA has received reports of sudden death among children and teens who
had heart problems and took Dexedrine. The agency says the new warning was
announced as a result of information it has received.

GlaxoSmithKline, the makers of Dexedrine, recently told doctors about the
drug's new labelling. The company warned 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.

A spokesperson for Glaxo confirmed the company agreed with the FDA's request
to add the warning - it also complied with the FDA's wording of it.

Two separate panels of outside 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.

Written by: Christian Nordqvist