Hyperactivity

...ba href=/hyperactivity/a/b disorder should not carry strong "black-box" warnings about potential cardiovascular and psychiatric risks.

Rather, the Food and Drug Administration pediatric advisory committee recommended that the drug labels include warning language written so people can understand it.

"I wouldn‘t use the word ‘tougher,‘ said panel chair Dr.

Robert Nelson, of the Children‘s Hospital of Philadelphia.

"‘Clearer.‘" The FDA was poised Wednesday to follow the more recent recommendations.

Any updated language may not appear on labels until pharmaceutical companies begin using a recently adopted format, something that could take several years.

And the FDA may yet require black-box warnings on stimulants to treat ADHD that would alert adults to increased risk of heart attacks, strokes and other similar problems, Temple said.

Psychiatrists and others had urged the committee to move cautiously before recommending strengthened warnings associated with the drugs.

The FDA then asked the pediatric panel to examine that same issue, as well as reports that psychosis or mania can occur in some juvenile patients at normal doses of any ADHD drug.

"I suggest confusion, polarizing viewpoints, initial press hysteria.

But then what?

" asked Julie Zito, a University of Maryland associate professor in pharmacy and psychiatry.

Psychiatrists and mental health advocates said leaving the disease untreated could rival the risks the drugs may pose.

Ritalin is manufactured...

...ba href=/hyperactivity/a/b disorder in children until more is learned about a possible link to a serious skin disease, federal advisers said Thursday.A Food and Drug Administration advisory committee voted 12-1 against recommending modafinil as safe for children with ADHD.

Earlier Thursday, the psychopharmacologic drugs panel agreed unanimously that the modafinil works in treating ADHD.The FDA is not required to follow the recommendations of its advisory committees but usually does.The committee recommended that Cephalon Inc.

undertake a 3,000-patient trial to determine what risk modafinil may pose for Stevens-Johnson Syndrome.

Drug reactions cause nearly all cases of the sometimes fatal skin disease, which can produce widespread blistering and rashes, according to The Merck Manual.The FDA's drug chief, Dr.

Robert Temple, said one out of roughly 900 children involved in earlier studies of the drug developed the disease.Temple and Cephalon spokeswoman Jenifer Antonacci said the agency and company would discuss the committee's recommendation.

The Frazer, Pa.-based company does not see a "clear link" between its drug and the skin disease, Antonacci said.In December 1998, the FDA originally approved modafinil, under the brand name Provigil, to treat adults with sleepiness associated with narcolepsy.

The company has proposed calling a higher-dose version of the pill Sparlon when used to treat ADHD.Other drugs already approved by the FDA for ADHD include Ritalin, Strattera and Adderall.A differ...

...ba href=/hyperactivity/a/b disorder and oppositional defiant disorder.

By 5, he was swallowing stimulant medicines to quell his behavior.

But the medicine brought equally unwanted problems, including vomiting, headaches, pasty white skin, and dark circles under his eyes from lack of sleep.

Psychiatrists added another medicine to balance these side effects.

When he became wilder, and even more moody, the doctors wanted to add a third drug.

And that's when his father, Rob Stevens of Garden City, said "no" to drugs.

His son is now 16 and shows no evidence of his former out-of-control self.

He's attentive, athletic, happy and does well in school.

"He's doing great," his father said.

"You'd never think that he ever had ADHD." What finally worked for their son was a drastic change in diet - addressing an old and controversial theory that certain substances such as wheat, dairy and artificial food coloring and flavoring trigger mood and behavior problems - and sensory integration training, to treat auditory imbalances.

Amanda Rose of Sachem is now 14 and has spent virtually all of her school years taking stimulant medication for ADHD.

"It really helps me," Rose said.

"I can focus and it keeps me on track." Two kids, two different experiences.

Throughout its 50-year history, stimulant medicines have been extolled and defamed, but they have become the mainstay for millions of children with problems staying focused and in control of behavior.

As other psychiatric medicines for children have ...