FDA Strengthens Warnings on ADHD Psychostimulant Drug Risks - New York Times
Tuesday, 22 August 2006
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.
These drugs which are controlled narcotics serve as gateways to incrementally more toxic psychotropic drugs and are prescribed for at least 4 million people (mostly children) who are diagnosed with the controversial "condition"-- ADHD (attention deficit hyperactivity disorder).
"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 AND AMPHETAMINE LIKE SUBSTANCES E.G. METHYLPHENIDATE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS."
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| MATTHEW SMITH DIED FEBRUARY 2000.HIS PARENTS VIEWS: |
According to Dr. Ljuba Dragovic, the Chief Pathologist of Oakland County, Michigan, upon autopsy, Matthew's heart showed clear signs of small vessel damage caused from the use of Methylphenidate (Ritalin).
The certificate of death reads: "Death caused from Long Term Use of Methylphenidate, Ritalin."
I was told by one of the medical examiners that a full-grown man's heart weighs about 350 grams and that Matthew's heart's weight was about 402 grams. Dr. Dragovic said this type of heart damage is smoldering and not easily detected with the standard test done for prescription refills. The standard test usually consists of blood work, listening to the heart, and questions about school behaviors, sleeping and eating habits.
What is important to note here is that Matthew did not have any pre-existing heart condition or defect.
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DANGER WARNING 'KEEP OUT OF THE REACH OF CHILDREN' BUT NOT OUT OF THEIR MOUTHS OR BODIES.THIS DRUG HAS EXACTLY THE SAME PHYSIOLOGICAL EFFECTS AS HEROIN,COCAINE AND AMPHETAMINES. (COURTESY OF WIKIPEDIA) |
See:
http://www.fda.gov/cder/foi/label/2006/011522s034s037,021303s013lbl.pdf:
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.
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.
http://www.nytimes.com/2006/08/22/health/policy/22fda.html?
THE NEW YORK TIMES
August 22, 2006
F.D.A. Strengthens Warnings on Stimulants' Risks
By GARDINER HARRIS
Earlier this year(2006), a FDA advisory panel voted 8–7 to add a black-box warning to the labeling of stimulants (eg, amphetamine mixtures, dexmethylphenidate, dextroamphetamine, methylphenidate), used to treat attention-deficit/hyperactivity disorder (ADHD) to alert prescribers about cardiovascular risks associated with use of the drugs. Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, or other serious cardiac problems that may be exacerbated by sympathomimetic effects. In adults, sudden death, stroke, and myocardial infarction have been reported with use of stimulants for ADHD.
The Food and Drug Administration (FDA) has received reports of more than 20 deaths associated with use of ADHD drugs, reviewers said. But, said Kate Gelperin, a medical officer in FDA's Office of Drug Safety, cardiovascular signals in ADHD adverse events reported to the agency were "not conclusive."
The Food and Drug Administration (FDA) has received reports of more than 20 deaths associated with use of ADHD drugs, reviewers said. But, said Kate Gelperin, a medical officer in FDA's Office of Drug Safety, cardiovascular signals in ADHD adverse events reported to the agency were "not conclusive."
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| STEPHANIE HALL DIED IN HER SLEEP THE FIRST NIGHT HER STIMULANT MEDICATION WAS INCREASED MARKEDLY.HER PARENTS CHALLENGED THE 'NATURAL CAUSES' VERDICT. |
Ritalin heart attacks warning urged after 51 deaths in US (GUARDIAN FEB 2006)
Move to highlight risks of drug prescribed to hyperactive children
Sarah Boseley, health editor
The Guardian, Saturday 11 February 2006
Ritalin, extensively prescribed to calm hyperactive children in the UK, should carry the highest-level warning that it may increase the risk of death from heart attacks, US experts recommended yesterday.
There have been 51 deaths among children and adults taking drugs for ADHD (attention deficit hyperactivity disorder) in the US since 1999. Yesterday the UK licensing authority, the Medicines and Healthcare Products Regulatory Agency (MHRA), said nine children had died in this country among a smaller population on medication. They declined to reveal the children's ages because of the possibility of identification.
In the US, doctors write 2m prescriptions for ADHD drugs for children every month and 1m for adults. In the UK, nobody knows how many people are on the drugs, which are licensed for children as young as six - although there are reports of them being given to children as young as three. A total of 361,832 prescriptions were written last year for Ritalin and other drugs of the methylphenidate class, which averages 30,153 a month.
The cause of death for two of the nine children who died in the UK was specifically heart-related: one had a heart attack and a second an enlarged heart. One was recorded as a "sudden death". One died of a haemorrhage in the brain and another of a swelling in the brain, two committed suicide and the last died of neonatal respiratory distress syndrome - presumably the mother was on the drugs.
The recommendation by an advisory panel of the Food and Drug Administration to put a "black box" warning - the most serious possible - on all ADHD drugs in the US is likely to be accepted. Pressure will mount now on the British authorities to warn publicly of the risk.
There is growing concern about the rising numbers of children being put on drugs. This class of drugs, known as methylphenidates, are amphetamine-based and it is thought they could cause heart problems in some children and adults because they raise blood pressure. There is already a warning on the drug most widely used in the US, Adderall, which is not licensed in the UK.
The FDA advisers said it was not certain the drugs contributed to the 51 deaths. "The data is only suggestive at this point, but because of the gravity of the side-effect, namely sudden death, physicians need to be made clearly aware of that concern," said Dr Peter Gross, the panel chairman and head of internal medicine at Hackensack University Medical Centre in New Jersey. One member of the panel was clear that he hoped the warning might slow down the soaring rate of prescription of the drugs to children who are inattentive or badly behaved at school. "I want to get people's hands to tremble a little bit before they write that [prescription]," said Steven Nissen, a panel member and cardiologist at the Cleveland Clinic.
Dave Woodhouse, psychologist and director of the Cactus Clinic, attached to Teesside University, which offers parents an alternative to drugs in the form of nutritional guidance and counselling, said: "One of the main issues is that fact that in the case of a lot of kids given Ritalin you don't know if they have a heart condition or not."
There are three methylphenidate drugs licensed in the UK - the bestselling Ritalin, Concerta and Equasym. The MHRA said there had been 521 reports of suspected adverse drug reactions, most of them in the past five years as more children have been put on them. It added that methylphenidate "is recognised to cause cardiovascular adverse effects", such as a racing or abnormal heartbeat and palpitations and increased blood pressure.
'Unexplained deaths higher among children taking Ritalin, study says,'
Children taking stimulant drugs such as Ritalin to treat attention-deficit hyperactivity disorder (ADHD) are several times as likely to...
By Shankar Vedantam
The Washington Post
Children taking stimulant drugs such as Ritalin to treat attention-deficit hyperactivity disorder (ADHD) are several times as likely to suffer sudden, unexplained death as children who are not taking such drugs, according to a study published Monday that was funded by the Food and Drug Administration (FDA) and the National Institute of Mental Health.
While the numbers involved were small and researchers stopped short of suggesting a cause and effect, the study is the first to rigorously demonstrate a connection between ADHD drugs and sudden death among children.
Doctors have speculated about such a connection because stimulants increase heart rate and have other cardiovascular effects. Physicians currently are advised to evaluate patients for cardiac risks before prescribing the drugs, and FDA officials said Monday that those guidelines do not need strengthening. Some 2.5 million children in the United States take ADHD medications such as Ritalin and Adderall.
FDA officials said Monday that given the seriousness of ADHD and the rarity of sudden death — which strikes fewer than 1 in 10,000 children — the benefits of the drugs outweigh their risks. Agency officials urged parents to discuss concerns with doctors rather than deciding on their own to discontinue a child's medication. The study's lead author, Madelyn Gould, said she agreed with the FDA's advice.
Gould and colleagues obtained information about 564 children who died suddenly and inexplicably between 1985 and 1996 and evaluated how many had been taking stimulant drugs by asking parents and caregivers and by reviewing medical documents.
For every such child the researchers then found another child closely matched in age, sex and other variables who died in a traffic accident.
Gould found that 10 children in the group that suffered sudden, unexplained death had been taking stimulant drugs, whereas only two children in the group killed in traffic accidents were taking such medications.
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