I thought that this drug has been around a long time, has a long
standing track record of safety and was well known and well tested?
After this drug has been used for fifty years could we now be finding
out that someone in the FDA or pharm corp might have been wrong or
(HEAVEN FORFEND) willfully misleading us???

First off, I have seen studies saying numbers much higher than 1 in a
1000 additional cases of psychosis, I will try to find some and post
it. Anyway, without even investigating it, the number "1 in a 1000
additional cases" sounds hokey to me. The number is so small it is
statistically meaningless. If there are two groups of children of 5
million each. One group getting Ritalin and the other group
unspecified. Medicated? Unmedicated? Which medication? The number
bandied about is 1% psychosis. That means out of 5 million chidren
in each group there would be 50,000 cases as opposed to 50,050
cases. Is this a statistically significate number? It most
certainly is not. There has also never been any sort of comparision
study done with 10 million children. I see some wool that is trying
to be pulled over my eyes here.
Kol Tuv
Nachum

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FDA Directs ADHD Drug Manufacturers To Notify Patients About
Cardiovascular Adverse Events And Psychiatric Adverse Events
26 Feb 2007

The U.S. Food and Drug Administration (FDA) today directed the
manufacturers of all drug products approved for the treatment of
Attention Deficit Hyperactivity Disorder (ADHD) to develop Patient
Medication Guides to alert patients to possible cardiovascular risks
and risks of adverse psychiatric symptoms associated with the
medicines, and to advise them of precautions that can be taken.

"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 concerns."

Patient Medication Guides are handouts given to patients, families
and caregivers when a medicine is dispensed. The guides contain FDA-
approved patient information that could help prevent serious adverse
events. Patients being treated with ADHD products should read the
information before taking the medication and talk to their doctors if
they have any questions or concerns.

ADHD is a condition that affects approximately 3 percent to 7 percent
of school-aged children and approximately 4 percent of adults. The
three main symptoms are inattention, hyperactivity, and impulsivity.
People with ADHD may have difficulty in school, troubled
relationships with family and peers, and low self-esteem.

An FDA review of reports of serious cardiovascular adverse events in
patients taking usual doses of ADHD products revealed reports of
sudden death in patients with underlying serious heart problems or
defects, and reports of stroke and heart attack in adults with
certain risk factors.

Another FDA review of ADHD medicines revealed a slight increased risk
(about 1 per 1,000) for drug-related psychiatric adverse events, such
as hearing voices, becoming suspicious for no reason, or becoming
manic, even in patients who did not have previous psychiatric
problems.

FDA recommends that children, adolescents, or adults who are being
considered for treatment with ADHD drug products work with their
physician or other health care professional to develop a treatment
plan that includes a careful health history and evaluation of current
status, particularly for cardiovascular and psychiatric problems
(including assessment for a family history of such problems).

As part of the Agency's ongoing regulatory activity, in May 2006 the
FDA directed manufacturers of these products to revise product
labeling for doctors to reflect concerns about adverse cardiovascular
and psychiatric events. These changes were based on recommendations
from the FDA Pediatric Advisory Committee and the Drug Safety and
Risk Management Advisory Committee. To help patients understand these
risks, an additional part of this revised labeling process is the
creation of a Patient Medication Guide for each individual product.