Hyperactivity

...ba href=/hyperactivity/a/b disorder use, the FDA listed several safety concerns and precautions that needed to be addressed.

Cephalon wants to market its sleep disorder treatment Provigil under the brand name Sparlon for ADHD.

In 2005, Cephalon booked Provigil sales of $512.8 million, accounting for 44 percent of the company's annual revenue.

On Wednesday, the FDA released a review completed in September by FDA reviewer Glenn Mannheim, who said the drug posed "unacceptable risks to children and adolescents" and recommended that the agency tell the company the drug was not approvable.

Safety risks included serious skin rashes and psychiatric adverse events including suicidal thoughts.

The FDA said it had not made a final decision on the matter and awaited the advice of Thursday's advisory panel.

In a research note, JPMorgan analyst David Shaw, who rates Cephalon "Overweight," expects the agency to require a risk management plan, which closely tracks use of the drug, and post-market studies as a requirement for approval.

As evidenced in an FDA panel meeting Wednesday to discuss the risks of ADHD drugs as a whole, critics suggest that the class of drug be given a "black box" warning that spells out the risks of suicidal thoughts and aggressive behavior.

Analysts believe that the worst that will happen to Sparlon is that a black box label will be required.

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...ba href=/hyperactivity/a/b disorder.

The Food and Drug Administration asked its pediatric advisory committee to review reports of those potential risks and then recommend how to relay that information to the public.

The agency has struggled since last year with that latter task.

LocalLinks "This is really the crux of where we are trying to go," Dr.

Dianne Murphy, director of the FDA's office of pediatric therapeutics, told the panel today.

Last month, the FDA's Drug Safety and Risk Management advisory committee voted to recommend adding "black-box" warnings to stimulants used to treat ADHD, alerting doctors, patients and parents of the uncertainty regarding the risk the drugs may pose to the cardiovascular system.

The warnings are the most serious that prescription drugs may bear.

The FDA is not required to follow the recommendations of its advisory committees, but usually does.

The panel was expected to vote late in the day today, after several hours of testimony by drug manufacturers and the public.

The latest reviews show that psychosis or mania can occur in some juvenile patients at normal doses of any ADHD drug.

The reviews included roughly 90 studies of the drugs as well as reports from doctors, parents and others.

The ADHD drugs include Ritalin, manufactured by Novartis Pharmaceuticals Corp.

and in generic form by other companies; Adderall, made by Shire Pharmaceuticals Inc.; and Strattera, produced by Eli Lilly and Co.

FDA officials say patients and doctors should be aware that th...

...ba href=/hyperactivity/a/b disorder because agency scientists have found that the widely used medications can trigger hallucinations in some young children.

Doctors report that patients age 10 and younger have seen snakes, polka-dot alligators and spiders under the mattress and have felt bugs crawling over them.

The frightening visions usually ended after the medication was stopped.

The FDA pediatrics advisory committee will also consider last month's recommendation by another FDA panel — the safety committee — that the drugs, which are stimulants known to raise blood pressure, carry a strong warning about heart risks.

The drug safety and risk management advisory committee recommended adding "black-box" warnings to stimulants used to treat attention deficit ba href=/hyperactivity/a/b disorder, alerting doctors, patients and parents to the risk the drugs may pose to the cardiovascular system.

The warnings are the most serious that prescription drugs may bear.

The drugs include Ritalin, manufactured by Novartis Pharmaceuticals Corp.

and in generic form by other companies; Adderall, made by Shire Pharmaceuticals Inc.; and Strattera, produced by Eli Lilly and Co.

An estimated 5 million Americans, 3.3 million of them children, take medication for attention deficit disorder-ba href=/hyperactivity/a/b.

Use of the drugs is growing rapidly among adults.

The FDA has been trying for a year to communicate risks associated with increasingly popular drugs.

"This is really the crux of where we are trying to go," Dr.

...