FDA: Concerned w/Psychiatric Risks with ADHD Drugs

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_http://www.smartmoney.com/bn/ON/index.cfm?story=ON-20050628-000653-1405_

(http://www.smartmoney.com/bn/ON/index.cfm?story=ON-20050628-000653-1405)

 

FDA: Concerned With Psychiatric

Risks With ADHD Drugs

June 28, 2005

 

By Jennifer Corbett Dooren

Of DOW JONES NEWSWIRES

 

 

WASHINGTON -(Dow Jones)- The Food and Drug Administration said it intends to

make labeling changes for a certain class of drugs used to treat attention

deficit hyperactivity disorder over concerns about psychiatric events

associated with the drugs.

 

The FDA said it would make labeling changes to Johnson & Johnson's (JNJ)

Concerta and other methylphenidate products describing psychiatric events

" such as visual hallucinations, suicidal ideation, psychotic behavior, as well

as

aggression or violent behavior. " The drugs are used to treat ADHD in adults

and children. Other drugs in the category include Novartis AG's (NVS)

Ritalin, which is also available as a generic.

 

The FDA made the statement Tuesday as part of background material posted to

its Web site ahead of a pediatric advisory committee meeting Wednesday and

Thursday.

 

An FDA spokeswoman declined to discuss the number of psychiatric adverse

event reports it has received related to Concerta and similar drugs, saying

the

data would be presented to the pediatric panel on Thursday.

 

A Johnson & Johnson spokeswoman wasn't immediately available to comment on

Concerta. ADHD is a disorder in which people have attention, or inattention,

problems that cause impairment in academic, work or social settings. People

with ADHD are often hyperactive and impulsive. ADD is a similar disorder

without the hyperactive behavior that is often associated with adults more than

children.

 

The panel of outside medical experts will be discussing adverse event

reports in children for several drugs including Concerta. The reports are

mandated

by law for drugs approved specifically for use in children and are discussed

before the pediatric panel on a periodic basis.

 

" In addition we believe it is critical to examine the other stimulant

products approved for ADHD...to determine if they too are associated with these

adverse events, " the FDA said in its statement. The agency also said it would

look at atomoxetine, a nonstimulant product sold under the brand name

Strattera by Eli Lilly and Co. (LLY).

 

The agency said it was currently reviewing adverse event reports for

so-called amphetamine products like Shire Pharmaceuticals PLC's (SHPGY)

Adderall as

well as for Strattera and hoped to bring the review to the pediatric panel

in early 2006.

 

Meanwhile, the FDA is seeking the panel's advice on what information it

should provide to the public about the ADHD drugs that are widely used in

children while it's collecting information on the number of types of

psychiatric

events possibly associated with ADHD drugs along with possible cardiovascular

risks.

 

The agency is concerned with possible cardiovascular events in people using

the drugs. Earlier this year Health Canada ordered Adderall off the market

after reports of sudden death in 20 patients, including 12 reports of stroke.

 

Last year the FDA required Shire to update Adderall's label in the U.S. to

warn that it should not be used in children or adults with structural cardiac

abnormalities.

 

The FDA said it's too soon to tell if ADHD drugs really increase

cardiovascular risk and that it was " pursuing additional means to better

characterize

the cardiovascular risks for all drug products approved for ADHD. " Among the

options, the FDA said, was long-term safety trials to look at cardiovascular

risks.

 

 

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