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August 30, 2006 - Stronger warning
labels regarding the safety of several medications used to
treat attention-deficit/hyperactivity disorder (ADHD) are
now in place.
In February 2006, a Food and Drug Administration
(FDA) advisory panel recommended adding strong (black-box)
warnings about potential heart attacks and other cardiovascular
risks — including stroke, high blood pressure, palpitations
and arrhythmia — for some people taking certain ADHD
drugs. Another advisory panel considered whether the FDA should
strengthen warnings about rare psychiatric side effects such
as mania, psychosis and suicidal thinking.
In May 2006, the FDA decided that black-box
warnings weren't justified in either case. Instead, the FDA
asked manufacturers simply to strengthen the warnings about
serious cardiovascular and psychiatric events linked with
ADHD medications. ADHD medications now featuring the stronger
warnings include Dexedrine, Adderall and Concerta. Possible
changes to other ADHD medications — including Ritalin
and Strattera — are under review.
The potential side effects of various
ADHD medications are serious, especially if you have a personal
or family history of heart problems. The new warnings encourage
doctors to check for a family history or physical signs of
heart problems before prescribing ADHD medications. If you
or someone in your family is taking ADHD medications, talk
to your doctor about the benefits and risks.
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