Published: June 28, 2005 2:06 PM
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.
– By Jennifer Corbett Dooren, Dow Jones Newswires;
202-862-9294;
jennifer.corbett@dowjones.com.
(END) Dow Jones Newswires
06-28-05 1405ET
Source:
http://www.smartmoney.com/bn/ON/index.cfm?story=ON-20050628-000653-1405
