SSRI-Research] FDA Strengthens Warnings on ADHD psychostimulant Drug Risks_NYT

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[sSRI-Research] FDA Strengthens Warnings on ADHD

psychostimulant Drug Risks_NYT

 

 

 

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

http://www.ahrp.org

 

The New York Times reports (below) that after months of foot dragging,

the FDA has finally issued additional warnings on the labels of widely

prescribed psychostimulant drugs--Ritalin, Adderall, Concerta--that

are prescribed for at least 4 million people (mostly children) who are

diagnosed with the controversial " condition " -- ADHD (attention deficit

hyperactivity disorder). These drugs serve as gateways to

incrementally more toxic psychotropic drugs.

 

" 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. "

 

Psychotropic drugs fall into three main classes: stimulants,

antidepressants, and antipsychotics. All these drugs have severe,

life-threatening adverse effects that can destroy normal brain

functioning. Increasingly, children are the market population targeted

by the drug industry with the aid and assistance of the FDA and the

psychiatric establishment--all of who are financially dependent on

drug manufacturers.

 

After years of denial, the evidence shows that stimulants cause the

same adverse effects that amphetamines do--which what these drugs are.

Psychostimulants have a " high potential for abuse " --i.e., they are

addictive; they can cause cardiac arrest in adults and children; and

FDA's own medical experts confirmed that these drugs cause

hallucinations in children.

 

In July, Shire added Black Box warnings to the label its

psychostimulant drug--Adderall--the following:

 

" AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF

AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG

DEPENDENCE. "

 

" MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS

CARDIOVASCULAR ADVERSE EVENTS. "

 

See:

http://www.fda.gov/cder/foi/label/2006/011522s034s037,021303s013lbl.pd

f:

See also July news report:

http://www.ahrp.org/cms/content/view/304/28/

 

If The New York Times had bothered to read independent critiques of

studies testing psychotropic drugs, it would surely not be repeatedly

transmitting uncritically, misleading, outworn arguments made by those

with a vested interest in the drug industry. The Times states: " dozens

of studies have shown [Ritalin] to be safe and effective. " However,

the poor quality of those studies have been severely criticized.

 

In 1999, the Agency for Healthcare Research and Quality reviewed 78

randomized controlled, peer reviewed, published studies of the drug

treatment of ADHD. It found that in 87% of the studies, the number of

dropouts and withdrawals and the reasons for such withdrawals were not

described, neither were the long-term effects and severity of adverse

effects: " overall, numerous deficiencies in the reporting of available

randomized controlled trials limit the assessment of their validity,

relevance, precision, and, therefore, their clinical application. Most

studies did not clearly describe clinically important information such

as the primary outcomes of interest "

(pp. 4-5). The reviewers could not conduct a comparative analysis of

the findings because of " the low quality of reporting and the large

number and heterogeneity of outcome measures and tests used in the

studies. " They reported that these scientifically flawed studies " show

a trend to general improvement over time regardless of treatment

Ritalin appears to reduce behavior problems in ADHD children as long

as it is taken. " (pp. 4-5).

 

See: Agency for Health Care Research & Quality. (1999). Treatment of

attention-deficit/hyperactivity disorder: Summary, evidence Report /

Technology assessment number 11. AHQR Publication No. 00-E005.

Retrieved

 

January 15, 2003 from http://www.ahrq.gov/clinic/adhdsum.htm

 

In 2006, the Oregon Drug Effectiveness Review Project, analyzed 2287

pieces of research -- virtually every investigation ever done on ADHD

drugs up to 2006 - to reach its conclusions: it found no evidence to

support the claims about these drugs' safety or the legitimacy of the

ADHD diagnosis. See:

http://www.ohsu.edu/drugeffectiveness/reports/documents/ADHD%20Final%

20Report%20Update%201.pdf

 

AHRP has received numerous reports from parents who say that after

taking stimulants, their children became manic and were then diagnosed

as having bipolar disorder (a.k.a. manic-depression) for which they

were then prescribed antipsychotics.

 

Contact: Vera Hassner Sharav

212-595-8974

veracare

 

 

http://www.nytimes.com/2006/08/22/health/policy/22fda.html?

hp & ex=1156219200 &

en=50705e06df3eb2a7 & ei=5094 & partner=homepage

 

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.

 

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