August 21, 2006
F.D.A. Orders Strong Warnings on Stimulants
By GARDINER HARRIS
The New York Times
WASHINGTON, Aug. 21 — Federal drug regulators have ordered
that strong
warnings be put on the labels of stimulants like Ritalin to
caution against
their use in adults or children with heart problems and to
alert physicians
that the drugs cause one child in a thousand to experience
hallucinations.
The new warnings are not as strong as those approved in
February by an
advisory committee for the Food and Drug Administration, but
they
significantly strengthen the risk information already on the
drugs.
“We’re not trying to scare people out of using these drugs,”
said Dr. Robert
J. Temple, director of the drug agency’s Office of Medical
Policy. “Still, I
would be extremely reluctant to put people with heart
failure on one of
these drugs.”
The warnings come after scattered reports of children
dropping dead suddenly
while taking the drugs. In some cases, the children were
later determined to
have had structural defects of the heart.
The new warnings advise against giving such children
stimulants. The
problem, though, is that structural heart problems
frequently go undiagnosed
because the tests needed to find such problems are often
expensive.
“The difficulty for parents is that doctors won’t do a
thousand-dollar heart
work-up for every kid,” Dr. Temple said. “The message here,
though, is that
you have to do your best to find these problems out. Listen
for murmurs.”
Heart problems are more common in adults.
The warnings state in part, “Sudden deaths, strokes and
myocardial infaction
have been reported in adults taking stimulant drugs at usual
doses.” In
addition to appearing on Ritalin, the warnings will be put
on the labels of
Adderall and Concerta.
At a meeting in February, an F.D.A. advisory committee
focused attention
unexpectedly on stimulants’ risks in adults after a report
suggested that
the drugs might double the risk for strokes and serious
arrhythmias in
children and adults. Such an increase may not be significant
in children,
whose overall heart risks are low, but could cause concern
in adults,
members said.
Dr. Steven E. Nissen, chairman of the cardiology department
at the Cleveland
Clinic Foundation and a prominent member of the February
committee, said in
an interview that he was pleased with the drug agency’s
action.
“I think this goes a long way,” Dr. Nissen said, “toward
properly warning
physicians and patients of the potential cardio and
psychiatric risks of
these drugs.”
Nearly four million people take stimulants to treat
attention deficit
disorder and hyperactivity, and their use is growing fastest
in adults.
One drug, Ritalin, has been marketed since 1955, and dozens
of studies have
shown it to be safe and effective. But no studies have been
of sufficient
duration or included enough participants to evaluate
stimulants’ long-term
effects on the heart.
Advisory committee members said they were concerned that any
heart risks
affecting adults who took stimulants could go undetected.
Dr. Temple said
the drug agency was exploring ways to study the problem.
Regards,
Catherine
Do not follow where the path may lead;
go instead where there is no path and
leave a trail.
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