New Warnings Urged for ADHD Drugs
FDA Panel Recommends Warnings of Rare Reports of Aggressive Behavior or Psychotic Symptoms
March 23, 2006 -- Government advisors urged new warnings and information for
parents of children using drugs to treat attention deficit hyperactivity
disorder (ADHD), though they avoided strong safety alerts backed by a separate
panel last month.
A committee of mostly pediatric experts urged the FDA to warn doctors and
parents about reports linking popular stimulant drugs to aggressive behavior,
manic episodes, and psychotic symptoms like hallucinations.
The reports remain rare among the estimated 2 million American children who
fill stimulant prescriptions each month. But experts said that events appeared
often enough that parents and their doctors should be alerted so that they can
stop the drug if such problems arise in their children.
They recommended that warnings be included in medication guides distributed
to parents along with children's prescriptions.
"[Parents should] be aware that this could happen, and it may be a
justification for stopping the drug," says Robert Nelson, MD, a critical care
specialist at the Children's Hospital of Philadelphia and the panel's
Some reports of suicidal thoughts or behaviors have cropped up in children
and adolescents taking some stimulant medications. Those reports were most
common with the ADHD drug Strattera, which is not a stimulant and already
carries a "black box" alert warning of potential suicide risk. The committee
concluded that further suicide warnings for stimulant drugs, including Ritalin,
Concerta, and Adderall XR, are not warranted at this time.
The agency received hundreds of reports of aggressive behavior during the
last five years in children taking stimulant drugs. Most of the events were
reported as mild, though up to 20% resulted in a significant injury or
hospitalization, the agency says. The labels of most stimulant drugs don't warn
of a potential for aggressive behavior.
Aggression is a common symptom of ADHD, so some outbursts would still be
expected in patients taking medication, researchers say.
But reports in the studies appeared to be significantly more common in
children taking active drugs than in those who took placebos, and experts urged
the FDA to add new warnings alerting parents and doctors to consider
withholding treatment if new aggressive behavior arises with the drug.
"Take the child off of it, see what happens. Those are messages we don't
give out enough," says Lauren L. Leslie, MD, a member of the panel and a
researcher at the Child and Adolescent Services Research Center in San
Experts also recommended new labels warning of a possibility of
hallucinations and mania amid dozens of reports that such symptoms can arise
for the first time in children taking ADHD drugs.
Tom Laughren, MD, head of the FDA's division of psychiatric products, says
the committee appeared "unimpressed" by more than 350 reports of suicidal
thoughts or behaviors in treated children over the last five years. Up to 20%
of middle and high school students already report such thoughts, and it was
unclear that drugs other than Strattera led to increased risk, he noted.
But Jacqueline Bessner, of Ishpeming, Mich., told the committee in a tearful
statement that she and her husband were never told to be on the lookout for
suicidal behavior in their daughter, Leanne. The 15-year-old committed suicide
last October 2.5 months after starting treatment with Concerta.
"There was no warning to us that this could have psychiatric behaviors" as
side effects, Bessner tells WebMD.