Panel backs new warnings on ADHD drugs

...ba href=/hyperactivity/a/b disorder, or ADHD.

The condition causes trouble with focus as well as ba href=/hyperactivity/a/b and impulsiveness.

Other ADHD drugs include Johnson & Johnson's Concerta, Novartis's Focalin, GlaxoSmithKline Plc's Dexedrine and Eli Lilly and Co.'s Strattera.

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Reports of hallucinations, heart problems linked to popular ADHD ...

... KTBS - Health - Reports of hallucinations, heart problems linked to popular ADHD medications #header { background-image: url(http://images.bimedia.net/designimages/ktbs_header.gif);} .sectiondiv { background-image: url(http://images.bimedia.net/designimages/ktbs_blade.gif);} .sectiondiv2 { background-image: url(http://images.bimedia.net/designimages/ktbs_blade.gif);} .sectiondiv3 { background-image: url(http://images.bimedia.net/designimages/ktbs_blade.gif);} #nav { background-image: url(http://images.bimedia.net/designimages/ktbs_nav_bkg.gif); } #ticker { background-image: url(http://images.bimedia.net/designimages/ktbs_ticker_bkg.gif);} Wednesday, March 22, 2006 McConathy staying put at NSU The Tim Fletcher KTBS Sweet 16 Webcast.

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Ritalin, Adderall And Strattera are the drugs that are linked to serious risks, including heart attacks and hallucinations.Officials with the Food and Drug Admin...

US FDA staff questions Cephalon drug for ADHD

...ba href=/hyperactivity/a/b disorder, in documents made public on Wednesday.

The staff reports were released ahead of an FDA advisory panel meeting on Thursday to discuss Sparlon, already sold as Provigil to treat sleep disorders.

Cephalon shares plunged as a much as 9.5 percent shortly after the documents were released, but then recovered to close up $1.45, or 2 percent, to $73.31 on Nasdaq.

In October 2005, the agency told the company Sparlon could be approved pending certain conditions.

But one month earlier, a staff reviewer said the drug carries serious risks of skin rashes and psychiatric disorders and should not be approved for ADHD, according to the documents.

"Despite the demonstration of clinical efficacy, the safety profile demonstrates increased and, in this reviewer's opinion, unacceptable risks to children and adolescents," the reviewer said in a memo dated Sept.

26, 2005.

The FDA has not made a final decision, and is seeking advice from outside experts on whether or not to approve the new ADHD use for the drug, known generically as modafinil.

Sparlon will come in smaller, film-coated tablets than Provigil, as well as different strength doses.

Merrill Lynch analyst Gregg Gilbert said the documents weighed on the Cephalon's shares but it would be hard to predict the meeting's outcome.

He added in a research note that it was "important to consider" that top FDA officials had already supported the drug for ADHD.

Thursday's panel meeting will come on th...

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