NEWSclips Date: August 22, 2006
F.D.A. strengthens warnings on stimulants
By Gardiner Harris
New York Times
WASHINGTON - 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 doctors 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 Office of Medical
Policy at the drug agency. "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 dying
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.
But structural heart problems often go undiagnosed because the
tests needed to find them can be 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."
The new warnings state in part, "Sudden deaths, strokes and
myocardial infarction have been reported in adults taking
stimulant drugs at usual doses."
The warnings will be put on Adderall and Concerta as well as
Ritalin.
At a meeting in February, an F.D.A. advisory committee focused
attention on stimulants´ risks in adults after a report
suggested that the drugs might double the risk of strokes and
serious arrhythmias. Such an increase may not be significant in
children, whose heart risks are low, but it could cause concern
in adults, committee members said.
Dr. Steven E. Nissen, chairman of the cardiology department at
the Cleveland Clinic Foundation and a 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. 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.
Dr. Temple said the F.D.A. was exploring ways to study the
problem.
F.D.A. strengthens warnings on stimulants
By Gardiner Harris
New York Times
WASHINGTON - 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 doctors 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 Office of Medical
Policy at the drug agency. "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 dying
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.
But structural heart problems often go undiagnosed because the
tests needed to find them can be 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."
The new warnings state in part, "Sudden deaths, strokes and
myocardial infarction have been reported in adults taking
stimulant drugs at usual doses."
The warnings will be put on Adderall and Concerta as well as
Ritalin.
At a meeting in February, an F.D.A. advisory committee focused
attention on stimulants´ risks in adults after a report
suggested that the drugs might double the risk of strokes and
serious arrhythmias. Such an increase may not be significant in
children, whose heart risks are low, but it could cause concern
in adults, committee members said.
Dr. Steven E. Nissen, chairman of the cardiology department at
the Cleveland Clinic Foundation and a 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. 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.
Dr. Temple said the F.D.A. was exploring ways to study the
problem.
