Accidental overdoses and side effects from
attention deficit drugs likely send thousands
of children and adults to emergency rooms,
according to the first national estimates
of the problem.
Scientists at the U.S.
Centers for Disease Control and Prevention
estimated problems with the stimulant drugs
drive nearly 3,100 people to ERs each year.
Nearly two-thirds overdoses and accidental
use could be prevented by parents locking
the pills away, the researchers say.
Other patients had side effects, including
potential cardiac problems such as chest pain,
stroke, high blood pressure and fast heart
rate.
Concerns over those effects have led some
doctors to urge the
Food and Drug Administration to require
a "black box," its most serious warning, on
package inserts for drugs such as
Ritalin, Concerta and Adderall. Yet
even doctors advising the FDA don't agree
on whether that's warranted.
The issue was discussed in a series of letters
in the New England Journal
of Medicine, including some from doctors
worried about the dangers of not treating
attention deficit hyperactivity disorder.
"The numbers (of side effects) are puny compared
to the numbers of stimulant prescriptions
per year," said Dr. Tolga Taneli, a child
and adolescent psychiatrist at University
of Medicine and Dentistry of New Jersey in
Newark. "I'm not alarmed."
Other health experts assert their positions
that Ritalin and other ADHD drugs are completely
unnecessary to treat ADHD and that there are
healthier and safer alternatives such as educational,
behavioral, nutritional and herbal therapies
which are touted as far more effective with
little or no risk at all.
An estimated 3.3 million Americans who are
19 or younger and nearly 1.5 million ages
20 and older are taking ADHD medicines. Ritalin
is made by Novartis Pharmaceuticals Corp.
of East Hanover, N.J.; Concerta by Johnson
& Johnson of New Brunswick, N.J., and
Adderall by Shire US Inc. of Newport, Ky.
Twenty-five deaths linked to ADHD drugs,
19 involving children, were reported to FDA
from 1999 through 2003. Health officials estimate
the problem could be significantly large since
most deaths linked to ADHD remain unreported
to the FDA. Fifty-four other cases of serious
heart problems, including heart attacks and
strokes, were also reported. Some of the patients
had prior heart problems.
Still, there hasn't been a clear estimate
of the scope of side effects. The
CDC report, while not a rigorous scientific
study, attempts to provide that by using a
new hospital surveillance network.
From August 2003 through December 2005, the
researchers counted 188 ER visits for problems
with the drugs at the 64 hospitals in the
network, a representative sample of ERs monitored
to spot drug side effects.
Doctors linked use of stimulant ADHD drugs
to 73 patients with side effects or allergic
reactions. Another 115 accidentally swallowed
ADHD pills, including a month-old baby, or
took too much.
"These are cases where a young child took
someone else's medication or they took too
much of their own," CDC epidemiologist Dr.
Adam Cohen said of the second group.
Nearly 1 in 5 patients was admitted to the
hospital, 1 in 5 needed stomach pumping or
treatment with medicines, and 1 in 7 had cardiac
symptoms. Sixteen percent of the side effects
involved interaction with another drug.
Besides cardiac problems, common symptoms
included abdominal pain, rashes and spasms,
pain or weakness in muscles, according to
Cohen. No patients died.
Extrapolating to all U.S. hospitals, the
researchers estimated 3,075 ER visits occur
each year.
In another letter in the journal, the heads
of the American Psychiatric Association and
the American Academy of Child and Adolescent
Psychiatry wrote they are concerned a black
box warning would discourage use of ADHD drugs,
raising patients' risks of academic failure,
substance abuse and other problems.
This past February, an FDA drug safety advisory
panel voted 8-7 for a black box warning. The
next month, another FDA panel instead recommended
data on cardiac and other risks go in a new
"highlights" section the agency plans to add
to the top of drug inserts.
Dr. Marsha Rappley, pediatrics professor
at Michigan State University, and two other
doctors on the advisory panels believe the
vote for a black box was premature.
She said studies show the drugs raise blood
pressure and pulse rates a bit, but it's unknown
whether that would harm children taking them
for years, and that cardiac risks may be higher
for adults.
Dr. Steven Nissen, cardiology chief at the
Cleveland Clinic, who had pressed for a black
box warning at the FDA panel meeting, said
ADHD drugs are powerful stimulants and inherently
risky. Nissen and other doctors say the drugs
are being prescribed to some who don't need
them.
This week, the FDA said it is "working diligently"
on "labeling changes that we feel accurately
reflect the available data and the advice
of the committees." The agency declined interview
requests.