Cephalon ADHD drug effective but not safe: panel

...ba href=/hyperactivity/a/b disorder (ADHD) in children and teenagers, even though data showed it worked, a U.S.

advisory panel said on Thursday.

The Food and Drug Administration group of outside experts said it was most concerned about the risk of skin rashes that can lead to hospitalization and called on the drug maker to conduct more clinical trials.

"I think we‘re dealing with some fuzzy information," said panel chairman Wayne Goodman, a psychiatrist at the University of Florida, adding that more patients needed to be studied before approval.

"I don‘t want to do that experiment in the post-marketing arena," Goodman said.

Provigil is already approved to treat sleep disorders, but Cephalon is seeking to sell it under the name Sparlon for children and teenagers with ADHD.

The ADHD version of the drug, known generically as modafinil, would be smaller and come in a wider range of doses.

The FDA granted conditional approval for ADHD in October 2005, but sought expert advice over lingering concerns about rashes as well as mania, aggression and other possible psychiatric effects.

"They‘d have to do a lot more work to show a reason for it to be marketed" if the skin risk showed up in future studies, FDA‘s Director of Psychiatry Products Thomas Laughren told reporters after the meeting.

Even if the wider use is approved, another FDA official said he was "virtually certain" Sparlon would come with the strongest warning possible.

"It at least gets a black box," Dr.

Robert...

FDA Panel Says New Warnings Needed For ADHD Drugs

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

The panel said the new information should be added to the existing warnings section of the labels.

The warnings wouldn't be placed in a so-called "black-box," which is the agency's strictest warning.

"We did not feel it rose to the level of ...

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Promoting Media Sanity for Kids

...ba href=/hyperactivity/a/b disorder (ADHD).

At face, these results seem to counter previous research suggesting kids' television viewing increased their chances of getting ADHD However, this new study was conducted on children who were already in kindergarten, around 5 years old.

The previous studies (including this one) had found that it's viewing television at very early ages - in the 1 to 3 range - that increases a child's chances of ADHD.

The thought is that television's rapid pace can influence the development of very young minds, teaching them to expect a fast pace that the real world can't duplicate.

So the debate continues.

What do you think?

Technorati tags: ADHD Television Continue reading...

send post to a friend Kids and Obesity: Where Do Marketers Fit In?

By Editors of Common Sense Media, March 6, 2006 Two significant stories have hit the wires today about kids and obesity.

One finds that sugary drinks have become a major contributor to teen obesity rates.

The other predicts that global childhood obesity rates will have increased dramatically by 2010.

Dr.

Philip James, the head of the International Obesity Task Force, said that junk food marketing factors in significantly.

Kids are "being exposed to the world's marketing might," he said.

"There needs to be a ban on all forms of marketing, not just television adverts." So what do you think: do the makers of foods with low-nutritional value have an obligation to make sure that they aren't targeting kid...

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