The Food and Drug Administration on Wednesday announced its decision to require
manufacturers of medications approved to treat Attention Deficit Hyperactivity
Disorder (ADHD) to inform patients of possible adverse effects of using all
types of ADHD drugs and approaches that can be used to minimize the risks.
The drugs of concern include Adderall, Adderall XR,
Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Focalin XR, Metadate CD,
Methylin, Methylin, Ritalin, Ritalin SR, Ritalin LA, and Strattera, which are manufactured
by a host of drug companies including Eli Lilly and Co, Novartis AG, Johnson
& Johnson, and Shire plc.
The ADHD drug makers have been told to produce Patient
Medication Guides to alert patients of possible risks of adverse cardiovascular
and psychiatric symptoms and the precautions they may take to minimize these
Patient Medication Guides are given to the patient, families
and caregivers when an ADHD medicine is dispersed. The information is intended
to prevent serious adverse side effects and remind patients of the possible
risks associated with the ADHD drugs.
Patients being treated with ADHD drugs are advised to read the
information in the FDA-pre-approved guides before taking the medication and
talk to their doctors if they have any questions or concerns, the FDA says in a
"Medicines approved for the treatment of ADHD have real
benefits for many patients but they may have serious risks as well," said
Steven Galson, M.D., Director, Center for Drug Evaluation and Research (CDER).
"In our ongoing commitment to strengthen drug safety,
FDA is working closely with manufacturers of all ADHD medicines to include
important information in the product labeling and in developing new Patient
Medication Guides to better inform doctors and patients about these
ADHD, which is characterized by three major symptoms, inattention,
hyperactivity and impulsivity, affects 3 to 7 per cent of schoolchildren and 4
percent of adults.
An estimated 2
million people in the
suffer from this condition.
"People with ADHD may have difficulty in school,
troubled relationships with family and peers, and low self-esteem
control," the FDA says.
The FDA's decision to provide patients with the information
on ADHD drugs came after the agency reviewed reports of cases in which patients
experienced adverse effects and concluded that patients who take ADHD drugs may
be at slightly increased risk of cardiovascular adverse events or psychiatric
According to the FDA, there have been reports of sudden
death in patients on an ADHD drug with underlying serious heart problems or defects
and reports of stroke and heart attack in adults with certain risk factors.
Taking ADHD medicines also increases risk by 1 per 1000 for
drug-related psychiatric events such as hearing voices, becoming suspicious for
no reason, or becoming manic, even in patients who did not have previous
The FDA requires the drug makers to produce a patient
medication guide for each ADHD medicine to give patients information on reported
adverse events, who should not take the drug, common side-effects, drug
and some basics about the medication.
Taking Adderall as an example, reported heart related
adverse events associated with this ADHD drug include sudden death in patients
who have heart problems or defects, stroke and heart attack in adults,
increased blood pressure and heart rate.
Again taking Adderall as an example, reported mental or
psychiatric problems associated with this ADHD medicine include new or worse
behavior and thought problems, bipolar illness, aggressive behavior or hostility
in all patients.
In children and
teenagers, the problems also include new psychotic symptoms including hearing
voices, believing things that are not true, and suspicious or new manic
Taking Adderall may also slow growth in children and cause
seizure, mainly in patients with a history of seizure, eyesight changes or
Common side effects with
this ADHD medicine include headache, decreased appetite, stomach ache,
nervousness, trouble sleeping dizziness, according to the patient medication
guide draft indicated for the medicine.
Other ADHD may have the same or similar adverse effects as
For the detailed guides for
each ADHD drug, visit http://www.fda.gov/cder/drug/infopage/ADHD/default.htm
The FDA recommends that patients who intend to use ADHD
drugs talk to their doctors or healthcare professionals to develop a treatment
plan that includes a careful health history and evaluation of current status,
particularly for cardiovascular and psychiatric problems.
In May 2006, the FDA already directed manufacturers of these
ADHD products to revise product labeling to remind doctors of adverse
cardiovascular and psychiatric events.
Critics complain that the FDA acts too slow.
In September 2006, Health
Canada already warned
patients of adverse cardiovascular events and psychiatric events associated
with all types of ADHD drugs.
For more information, visit the following
* Adverse effects of ADHD drugs
* List of Patinet Medication Guide Drafts
* ADHD drugs and Cardiovascular risk
General information on ADHD