Understanding the Latest ADHD Medicine
Warnings
by Richard Rubin, MD
Clinical Associate Professor, University of
Vermont
On Feb. 21, the national news media reported
that the FDA issued new warnings about sudden
cardiac death and increased psychiatric
disturbance. However, this action is not
based on new harm events. It is the fourth
step in a review process beginning three
years ago. The first was review by Canadian
and American authorities of 20 death and
stroke events in children and adults taking
stimulants for ADHD in 2005. A Canadian
government medical panel concluded that such
adverse events were not clearly due to the
medicines, but required ongoing concern and
study, particularly in people with
pre-existing heart abnormalities. Second, the
American FDA advisory committee reached
similar conclusions in March 2006. It
directed the FDA to update the class specific
warnings in all ADHD medicine package inserts
provided to doctors, many with decades old
language. This third step was published in
October 2006, covering both the cardiac risks
and worsening psychiatric conditions that
seem medicine related. The committee also
advised that pharmaceutical companies should
develop patient information guides under FDA
supervision. The Feb. 21 announcement is this
fourth step, the availability of these
guides. In addition to public distribution by
doctors and pharmacies, they can be accessed
now at www.fda.gov.
Combining multiple recent medical education
and scientific reports, the responsibility of
prescribing doctors for all the currently
approved ADHD medicines now is identification
of patients with sudden death risks. These
people will require further cardiac
evaluation before prescribing. 1) Take a
medical history of the patient for
pre-existing heart structure and function
diagnoses. 2) Take a family history of heart
disorders and young adult unexplained death.
3) Question about current signs such as
fainting or chest pain during exercise. In
the absence of such factors, the sudden death
risk from ADHD medicines is unknown at this
time, according to a statement Feb. 21 by the
National Institute of Mental Health director.
The risk for causing or worsening severe
psychiatric disorder is focused on two
circumstances. First, approximately 1 in 1000
children have developed psychotic symptoms
such as hallucinations on stimulants. These
usually resolve when the medicine is stopped.
Secondly, all the medicines, both stimulants
and non-stimulants, are reported to
precipitate or exacerbate bipolar disorder
(previously called manic-depressive illness)
in children and adults. While all such
adverse events cannot be predicted,
prescribing doctors have a duty to identify
those at higher risk. 1) Take initial history
of past signs and disorders. 2) Take family
history for such thought and mood disorders.
3) Examine for current disturbance combined
with or mimicking ADHD. This includes the
common problems of covert substance abuse and
emotional trauma. Such disorders do not
necessarily exclude ADHD medicine, but they
may require treatment first or in addition.
Further, as these risks can emerge at any
time, the patient on medicine needs continued
monitoring. The doctor should confirm with
the patient and parents their responsibility
to report new signs of disturbance. All in
all, these new information guides can improve
our understanding and appropriate use of
medicines, compared to the risks of not
treating ADHD.
Dr. Rubin practices Child and Adult Psychiatry,
directs The Clinical Study Center in Burlington
Vermont, and serves as Clinical Associate
Professor
at the University of Vermont College of Medicine.
