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FDA Panel: No Black Box Warning for ADHD Drugs

FDA Panel: No Black Box Warning for ADHD Drugs

Moving with decidedly unbureaucratic
swiftness, an FDA
advisory panel has reversed an earlier call by another committee for
restrictive black box labeling on
medications prescribed for children
with attention deficit hyperactivity
disorder (ADHD).

"Do parents need to worry about the
risks? In a word, no," said Robert W.
Nelson, MD, chair of the FDA's Pediatric
Advisory Committee, at the end
of the committee's March meeting at
which it called for improved communications
between the agency and physicians
and parents.

"The important thing to remember
is that this meeting was about children,"
he said. "The data for the efficacy of
the medications was quite strong. We
did feel that there is a need for the FDA
to improve its communications. But,
while there are some concerns, they did
not rise to [the] level of a black box

"The committee was not impressed
with the level of cardiovascular risk
to children," added Robert Temple,
MD, director of the FDA's Office of
Medical Policy.

Nelson's committee was responding
to the action of the FDA's Drug Safety
and Risk Management
Advisory Committee,
which had
voted in February to recommend adding
a black box warning on labels for stimulants
used in the treatment of ADHD.

The DSaRM recommendation, which
was approved by an 8 to 7 vote with 1
abstention, came after the committee had
reviewed evidence of cardiovascular

151;including reports of sudden

151;in patients taking the stimulants.

Its action in recommending
black box warning
caught FDA officials
by surprise and drew some
criticism from adolescent and child
psychiatrists who felt the panel was
lumping concerns about children with
those of adults.

Black box warnings represent the
most extreme level of caution from the
FDA. They are widely perceived to
influence prescribing; a study of more
than 320,000 prescriptions that was
published in the Archives of Internal
Medicine earlier this year reported that
99.3% were written in compliance with
black box warnings.

According to the FDA, "black box
warnings are designed to highlight
special problems, particularly those
that are serious, and to give health care
professionals a clear understanding of
a potential medical complication associated
with a drug. Black box warnings
provide physicians with important
insights as to how to prescribe a drug
that may be associated with serious side
effects in a way that maximizes its benefits
and minimizes its risks."

In addition, the panel voted 15 to 0
with one abstention to recommend that
the FDA develop "MedGuides" (the
descriptive pamphlets given out by
pharmacists with prescription medications
to make patients aware of potential
side effects or concerns about a
drug) to warn of potential cardiovascular
risk from stimulant drugs used in
the treatment of ADHD.

"The [DSaRM] committee was
composed largely of people working with
adults, said David Fassler, MD, clinical
professor of psychiatry at the University
of Vermont College of Medicine, who
testified at the March hearing.

"They were more focused on adult
treatment and didn't include input from
clinicians who actually work with children
and adolescents. I was surprised
by their actions, since the agenda of the
committee was to discuss appropriate
research methodology to determine
whether or not these medications posed
a risk in terms of cardiac functioning.
Instead, the committee decided to use
the hearing to make a statement about
its concerns related to the increased use
of these medications in general."

Fassler, testifying as a trustee of the
American Psychiatric Association
(APA), noted that "For the period 1999
to 2003, there were 25 reports of patients
who died and 54 reports of patients who
experienced other cardiac complications.
During this time, there were 78
million prescriptions for these medications
. . . [M]ost patients can and do
take these medications without significant
difficulties or complications."

"However, any side effects need to
be taken seriously, particularly when they
involve even the slightest risk of sudden
death. For this reason, I fully support
the call for more research on both the
safety and efficacy of medication used
in the treatment of ADHD. I also support
the call for updated labeling language
and for the development of MedGuides
and fact sheets specific to these medications.
Physicians and patients need and
deserve as much information as possible
in order to make fully informed decisions
about treatment options."

"If you talk to most psychiatrists who
are treating patients in their 50s with
ADHD, they wouldn't be putting them
on a stimulant, added Adelaide S.
Robb, MD, medical director of the
clinical trials unit at Children's National
Medical Center in Washington, DC. The
DSaRM committee, she said, "was like,
'Ooooh. This medication might make
the patient's blood pressure go up 1
point.' It had nothing to do with the
population that is being treated."

Robb pointed out that "one of the
things that has happened is that the FDA
is being pressured by outside groups,
including Congress, to take a look at
safety and efficacy issues. When reports
come out about safety questions, it's
important to take a look at them.

"The meeting in February of the
DSaRM committee was called to give
us advice on how to study these drugs,"
said Thomas Laughren of the FDA's
Office of Drug Evaluation. "They did
give us advice on labeling. The Pediatric
Advisory Committee meeting was
much more balanced and thorough in
terms of defining the benefits and risks.
I think we got some good advice."

"We were better prepared [at the
Pediatric Advisory] meeting to deal
with the question because it was on the
table," he added. "I think we got some
good background on options, from
doing nothing to the most severe warning,
which is a black box. After hearing
all the data, the committee decided
that the risk did not rise to a level that
would justify a black box."


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