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Concerns About Concerta - Hypertension and other Cardiovascular Conditions
Courtesy of the FDA
Caution is indicated in treating patients whose underlying medical conditions
might be compromised by increases in blood pressure or heart rate, eg, those
with preexisting hypertension, heart failure, recent myocardial infarction, or
hyperthyroidism. Blood pressure should be monitored at appropriate intervals in
patients taking CONCERTA®, especially patients with hypertension.
In the
laboratory classroom clinical trials in children (Studies 1 and 2), both
CONCERTA® qd and methylphenidate tid increased resting pulse by an average of
2-6 bpm and produced average increases of systolic and diastolic blood pressure
of roughly 1-4 mm Hg during the day, relative to placebo.
In the
placebo-controlled adolescent trial (Study 4), mean increases from baseline in
resting pulse rate were observed with CONCERTA® and placebo at the end of the
double-blind phase (5 and 3 beats/minute, respectively). Mean increases from
baseline in blood pressure at the end of the double-blind phase for CONCERTA®
and placebo-treated patients were 0.7 and 0.7 mm Hg (systolic) and 2.6 and 1.4
mm Hg (diastolic), respectively.
Weitz & Luxenberg is no longer accepting Concerta cases.
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