ADHD changes to FDA medication warnings

[Guest guest]

There was an article on MEDSCAPE in regards to change in legislation for

packaging of ADHD drugs and as a parent who has lost a child I am happy

to see it!

Let me stress, I am not against medications - these can be of great

benefit - I am however, against their use in children who have not

undergone cardiology testing prior to its commencement. My child had a

structural heart defect that had never been identified.

I am fearful that some of the less approachable doctors will simply

shrug off their patient's request for testing; afterall, it is a

cost-efficient world where these exams take up time and money. That

said, I hope that people will be proactive and insist because their

children's health is what is at stake and no one knows which of us have

a child with a structural/rhythm heart problem unless the proper tests

are performed:

If using stimulant-type medications for symptoms of ADHD, request an

ultrasound of the heart, not simply an Electrocardiogram, but an

Echocardiogram.

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February 28, 2007

— On February 21, 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).

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 cardiovascular 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 cardiovascular events (eg, sudden death, stroke, and myocardial

infarction) 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 clinician 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 -

4 mm Hg and 3 - 6 bpm, respectively), some patients may experience

excessive changes. Particular caution is advised when treating those

with preexisting hypertension, heart failure, recent myocardial

infarction, 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 1 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 (eg, hearing voices, believing

things that are not true, or being suspicious) that should be reported

immediately.

Each patient medication guide will also include drug-specific

information regarding therapeutic contraindications and drug

interactions as well as appropriate dosing guidelines and other

potential adverse events (eg, the risk for severe liver damage in

patients receiving atomoxetine HCl therapy (Strattera capsules, Eli

Lilly and Co).

Products for which a patient medication guide is being drafted include

mixed salts of a single entity amphetamine product tablets and

extended-release capsules (Adderall and Adderall XR, made by Shire

Laboratories), methylphenidate HCl extended-release tablets (Concerta,

made by Alza Corp), methylphenidate transdermal system (Daytrana, made

by Noven Pharmaceuticals, Inc), methamphetamine HCl tablets (Desoxyn),

and dextroamphetamine sulfate spansule capsules and tablets (Dexedrine,

made by GlaxoKline).

Medication guides are also being developed for dexmethylphenidate HCl

tablets and extended-release capsules (Focalin and Focalin XR, made by

Novartis Pharmaceutical Corp); methylphenidate extended-release capsules

(Metadate CD, made by UCB Pharma, Inc); methylphenidate oral solution

and chewable tablets (Methylin, made by Mallinckrodt Inc);

methylphenidate tablets, sustained-release tablets, and extended-release

capsules (Ritalin, Ritalin SR, and Ritalin LA, made by Novartis

Pharmaceuticals Corp); and atomoxetine HCl capsules (Strattera, made by

Eli Lilly and Co).