Healthy Skepticism Library item: 3890

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Publication type: news

Harris G.
Panel Advises Disclosure of Drugs' Psychotic Effects
New York Times 2006 Mar 23
http://www.nytimes.com/glogin?URI=http://www.nytimes.com/2006/03/23/health/23fda.html&OQ=_rQ3D1Q26eiQ3D5094Q26enQ3De18b3ebe56dce6bfQ26hpQ3DQ26exQ3D1143090000Q26partnerQ3DhomepageQ26pagewantedQ3Dprint&OP=3136e9cbQ2FQ2AQ2FCQ5CQ2A1qbmGqqjlQ2AlQ24Q249Q2AQ24dQ2AldQ2AzCoMjzQ2AldQ3B1oQ5BzjEM

Keywords:
hallucinations Ritalin ADHD

Notes:

Ralph Faggotter’s Comments:

“…out of 100 patients treated for a year with stimulants, 2 to 5 will
suffer serious psychotic episodes like hallucinations.
“It’s a small number, but it’s real,” said Dr. Robert M. Nelson…”

Excuse me, but 5% of children suffering such disturbing reactions adds up to over 100,000 children in the USA alone- hardly a small number!

Full text:

http://www.nytimes.com/2006/03/23/health/23fda.html?ei=5094&en=e18b3ebe56dce
6bf&hp=&ex=1143090000&partner=homepage&pagewanted=print
THE NEW YORK TIMES
March 23, 2006
Panel Advises Disclosure of Drugs’ Psychotic Effects
By GARDINER HARRIS

GAITHERSBURG, Md., March 22 –
Stimulants like Ritalin lead a small number of children to suffer
hallucinations that usually feature insects, snakes or worms, according to
federal drug officials, and a panel of experts said on Wednesday that
physicians and parents needed to be warned of the risk.

The panel members said they hoped the warning would prevent physicians from
prescribing a second drug to treat the hallucinations caused by the
stimulants, which one expert estimated affect 2 to 5 of every 100 children
taking them. Instead, they said, the right thing to do in such cases was to
stop prescribing the stimulants.

On Feb. 9, a different advisory committee voted 8 to 7 to recommend that the
Food and Drug Administration place its most serious warning label, a
so-called black box, on the labels of stimulants to warn that they could
have dangerous effects on the heart, particularly in adults. That
recommendation grew out of reports that 25 people, mostly children, had died
suddenly while taking the drugs.

The twin conclusions come more than 50 years after Ritalin was first
approved to treat attention deficit disorder and hyperactivity. Since then,
stimulants have become among the most widely prescribed medicines in the
world. In the United States alone, about 2.5 million children and 1.5
million adults take them; as many as 10 percent of boys ages 10 to 12 do. In
addition to Ritalin, two other stimulants, Adderall and Concerta, are
popular.

The drugs have been studied in hundreds of trials over five decades and have
proven to be extremely effective. But they have always been controversial,
with some experts saying they are overprescribed. It is a measure of the
difficulty of uncovering the physiological effects of medicines that experts
are only now grappling with some of the drugs’ serious, though rare,
physical and mental effects.

Dr. Thomas B. Newman, an epidemiologist at the University of California, San
Francisco, who is a member of the pediatric advisory committee, estimated
that out of 100 patients treated for a year with stimulants, 2 to 5 will
suffer serious psychotic episodes like hallucinations.
“It’s a small number, but it’s real,” said Dr. Robert M. Nelson, an
intensive-care physician at Children’s Hospital of Philadelphia and chairman
of the committee.

Dr. Kate Gelperin, an F.D.A. drug-safety specialist, told the committee that
the agency had discovered a surprising number of cases in which young
children given stimulants suffered hallucinations. Most said that they saw
or felt insects, snakes or worms, Dr. Gelperin said.

Dr. Gelperin described the case of a 12-year-old girl who said that insects
were crawling under her skin. Another child was found by his parents
crawling on the ground and complaining that he was surrounded by
cockroaches. In both cases, the hallucinations disappeared after drug
therapy was stopped. The boy’s doctor persuaded his parents to give him
stimulants again, and his hallucinations reappeared.
F.D.A. officials made clear to the advisory panel that they considered the
reports of hallucinations a problem that deserved a label warning.
“We were struck by the hallucinations,” said Dr. Rosemary Johann-Liang,
deputy director of the division of drug-risk evaluation at the F.D.A. “We
felt it was a drug effect.”

The agency does not have to follow the conclusions of its advisory panels,
but it usually does. Dr. Robert Temple, director of the Office of Medical
Policy at the agency, said after the meeting that the agency would “turn
quite quickly to implementing the recommendations we’ve gotten.”
Dr. Temple added, “The area of uncertainty is what to do about the black-box
warning on cardiovascular risks in adults.”

After the advisory committee meeting in February, agency officials said they
had no intention in the near future of placing such warnings on stimulant
labels about their potential heart risks.

Wednesday’s panel, made up mostly of experts in pediatric medicine and
psychiatry, discussed only the potential risks of the drugs among children,
while February’s group focused mostly on the risks to adults. The pediatric
panel agreed with the earlier group that children who have heart problems
should probably not be given stimulants. But most children who die suddenly
from heart ailments never knew they were at risk, and most children put on
stimulant therapy are not given thorough heart evaluations.
“You can’t screen 2.5 million children” with intensive heart evaluation
tests, Dr. Nelson said. Copyright 2006The New York Times Company