FDA: Concerned With Psychiatric Risks With ADHD Drugs
June 28, 2005


By Jennifer Corbett Dooren
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.