The FDA asks that medication guides note CV risks with ADHD drugs

Yael Waknine

February 27, 2007

Rockville, MD - On February 21, 2007, the FDA informed healthcare professionals regarding the development of new patient medication guides to be dispensed with all medications approved for the treatment of attention deficit hyperactivity disorder (ADHD) [1].

According to an FDA news release, ADHD is a condition that affects approximately 3% to 7% of school-aged children and about 4% of adults. The main symptoms are inattention, hyperactivity, and impulsivity; individuals with ADHD may have difficulty in school, troubled relationships with family and peers, and low self-esteem.

The guides are intended to inform patients and their families/caregivers of potential CV and psychiatric risks associated with use of ADHD medications and to advise of precautions that can be taken, according to an alert sent from MedWatch, the FDA's safety information and adverse-event reporting program.

Information provided in the guides is consistent with the FDA class-labeling initiative of May 2006 to revise ADHD drug-safety labeling for healthcare professionals according to recommendations from the agency's Pediatric and Drug Safety and Risk Management advisory committees.

Each guide contains a black-box warning for patients regarding reports of sudden death associated with use of ADHD drugs at normal doses in children and adolescents with structural cardiac abnormalities or other serious heart conditions.

Serious CV events (eg, sudden death, stroke, and MI) have also occurred in adults with certain risk factors such as serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, and coronary artery disease.

Children, adolescents, and adults who are being considered for treatment with ADHD therapy are advised to work with their physician or other healthcare professional to develop a treatment plan that includes a careful health history and evaluation of current status as well as family history of related disorders.

Patients should report heart problems, defects, high blood pressure, or a history of these problems to their healthcare provider. Use of ADHD drugs is not recommended in patients with structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems.

The need for regular monitoring of blood pressure and heart rate during therapy is also explained. Although usual mean increases are modest (2 to 4 mm Hg and 3 to 6 bpm, respectively), some patients may experience excessive changes. Particular caution is advised when physicians are treating those with preexisting hypertension, heart failure, recent MI, or ventricular arrhythmia.

Patients are advised to contact their healthcare provider immediately for cardiac evaluation of symptoms suggestive of cardiac disease such as chest pain, shortness of breath, or fainting.

The black box also warns that ADHD therapy can exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychiatric illness and explains the need for disclosure of current mental problems and family history of suicide, bipolar illness, or depression during the pretreatment screening process.

Findings from an FDA review of ADHD drugs are also provided, notably that use of ADHD drugs at normal doses in children and adolescents with no history of psychotic conditions has been linked to a slight increased risk (approximately one in 1000) for treatment-emergent psychotic/manic symptoms (eg, hallucinations, delusional thinking, and mania).

Patients are advised to contact their healthcare provider immediately for new or worsening mental behavior/thought problems, bipolar illness, or aggressive behavior/hostility. Children and teenagers may be at risk for new manic or psychotic symptoms, all of which should likewise be immediately reported.


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