Healthy Skepticism Library item: 5920

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Publication type: news

Harris G.
F.D.A. Strengthens Warnings on Stimulants' Risks
New York Times 2006 Aug 22
http://www.nytimes.com/2006/08/22/health/policy/22fda.html?_r=1&hp&ex=1156219200&en=50705e06df3eb2a7&ei=5094&partner=homepage&oref=slogin

Full text:

THE NEW YORK TIMES
August 22, 2006
F.D.A. Strengthens Warnings on Stimulants’ Risks
By GARDINER HARRIS

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 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.