Medical History Can Identify Serious Drug Treatment
Risks
by Richard Rubin, MD
Clinical Associate
Professor, University of Vermont College of Medicine
Decision dilemmas about ADHD medicine safety are
significantly helped by initial careful review of an
individual’s health history and physical condition.
Two serious health events have recently raised
concern: sudden cardiac death with Mixed Amphetamine
Salts (Adderall) and liver toxicity with Atomoxetine
(Strattera). MAS sudden heart death has occurred at
a rate of approximately 2 in a million patients over
6 years time and only 1 atomoxetine liver toxicity
case has been documented among 3.5 million patients
in 3 years. Despite this rarity, warnings are now
included in the official public medicine
information, known as the Package Insert or Product
Label. While the data are not as clear, the U.S.
Food and Drug Administration is also considering
updated warning language about sudden cardiac death
with the Methlyphenidate stimulants (Ritalin,
Metadate, Concerta, Focalin).
Health assessment before starting medicine is
particularly important because there are no specific
tests for predicting either the cardiac or hepatic
events in healthy people. Sudden cardiac death has
been associated with a history of structural heart
defects and may account for several of the reported
MAS deaths. Therefore MAS should not be prescribed
with these pre-existing conditions. If a heart
disorder has not been diagnosed, unexplained deaths
in family members below age 30 may provide another
clue. Current health signs are important also,
particularly high blood pressure and fainting
episodes. If present, more extensive heart testing
for silent defects is justified before MAS or other
stimulant medicines are prescribed. Additional
caution is wise during intense cardiac stress
exposures, such as football players training in hot
weather and bike racers producing high pulse rates.
In the absence of these past or current risk
factors, there appears to be no cardiac risk reason
to avoid ADHD treatment with MAS, and probably the
Methylphenidate stimulants also.
Because the one documented case of acute liver
toxicity associated with Atomoxetine has been
officially called “idiosyncratic”, meaning no
identifiable cause, prior health condition risks
have not been identified. However, increase in the
blood levels of certain liver enzymes (ALT, AST,
GGT) occurs in liver injury from multiple causes
that may be confused with possible Atomoxetine
effects. These include virus illnesses, alcohol use,
and common medicines such as acetominophen
(Tylenol). Since mild liver enzyme elevations can
occur for many reasons, further evaluation is
usually needed only if the person becomes sick, the
increase is over twice the normal range, or
additional tests are abnormal. While absence of
these prior health problems makes heart and liver
medicine harm very rare in healthy people, ongoing
awareness and study are needed to keep learning more
about ADHD medicine risks relative to potential
benefits.
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.
