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Sparlon Not Approved for ADHD Treatment

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An FDA advisory panel voted against recommending the approval of the drug Sparlon for the treatment of ADHD in children and teenagers.
 
Their main concern was the risk of Stevens-Johnson Syndrome, a rare but serious skin disorder manifested by blistering and rashes which often requires hospitalization and can even be fatal.
 
The drug is already used under the name Provigil as a sleep disorder treatment for adults.

ADHD drug not safe for kids

News-Medical.net - 3/26/2006 7:15 PM

According to a panel of experts advising the U.S. Food and Drug Administration (FDA), the drug Provigil, although effective in treating attention deficit hyperactivity disorder (ADHD) in children and teenagers, is not safe enough to win approval.
 
The experts say they are most concerned about the risk of skin rashes that can lead to hospitalization and have called on the drugmaker Cephalon to conduct more clinical trials.
 
The committee has recommended that Cephalon carry out a 3,000-patient trial to determine what risk the drug may pose for the sometimes fatal skin disease Stevens-J
 
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