Children Rx ADHD Drugs 7.4 times increased risk of sudden death

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Children Rx ADHD Drugs 7.4 times increased risk of sudden death

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Wednesday, 17 June 2009

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But FDA says keep taking the **medicines.** Empirical findings published

in the American Journal of Psychiatry lend validity to the long debated

claim by critics of stimulant drugs prescribed for ADHD: that the short and

long term risks are serious; the diagnosis, controversial; and the benefits

are short-lived.

 

 

The study, led by Dr. Madelyn Gould of the New York State Psychiatric

Institute and Columbia University, involved 564 children who died suddenly.

Those who had been taking stimulant drugs (i.e., amphetamines) were 7.4 times

more likely to die of cardiac arrest (sudden death) than those not taking

stimulants.

 

 

ADHD remains a controversial behavioral **condition** about which there

is no consensus either about diagnostic criteria or appropriate treatment.

Therefore, the risk of cardiac arrest from a controversial treatment is

unethical.

 

 

The researchers state: **Although sudden unexplained death is a rare

event, this finding should be considered in the context of other data about the

risk and benefit of stimulants in medical treatment.**

 

 

Not so, say FDA officials who were quick to defend the drugs, no doubt, in

order to help drug manufacturers, including: Shire Pharmaceuticals Group

PLC*s Adderall, Johnson & Johnson*s Concerta, Eli Lilly & Co.*s Strattera

and Novartis AG*s Ritalin--maintain profit margins.

 

 

The FDA, which partly funded the study, said there isn*t enough evidence

to conclude the drugs are dangerous and recommends people continue taking

their medications.

 

 

How many additional dead children will it take to convince these **public

servants** that their responsibility is protect children, not profit

margins of Shire, Johnson & Johnson, Eli Lilly and Novartis?

 

Posted by Vera Hassner Sharav

 

~~~~

 

 

_ADHD Drugs Linked to Sudden Death_

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Some Parents Believe New Study Reinforces Link Between Stimulants, Cardiac

Death

 

 

By DAN CHILDS and TODD NEALE

ABC News Medical Unit in Collaboration with MedPage Today

June 15, 2009—

 

 

For Ann Hohmann, Oct. 21, 2004, began just about like any other day.

 

 

On that morning, the 54-year-old mother of two living in McAllen, Texas,

was preparing to take her eldest son to school. She had an early

appointment, so her husband, Rick Hohmann, would be dropping off younger son,

14-year-old Matthew, at his school that day.

 

 

About a month earlier, Matthew had been diagnosed with attention deficit

hyperactivity disorder, or ADHD. And like an estimated 2.5 million other

children in the United States, he was taking medication for the condition. It

was Ann Hohmann who gave Matthew his Adderall XR pill that morning with a

glass of water. But it was her husband who later found him after he had

collapsed on the bathroom floor. **To me, he seemed fine,** she recalled. **My

husband had seen him walking around, brushing his teeth. Then he walked in

and found him flat down on the floor in the bathroom. When he turned him

over, his lips were blue,** Hohmann said.

 

 

She said that her husband called her first, and then he called 911. He

performed CPR until the ambulance arrived. But it was too late.

** They worked on him for a while, but he was dead,** she said.

 

 

Ann Hohmann is one of a handful of parents across the country who believes

that their children*s sudden death was due to the use of drugs to control

ADHD. And she said she hopes a new study released this morning, which

suggests that the use of stimulants is tied to an increased risk of sudden

unexplained death among children and teens, will open the eyes of the public to

what she sees as the cause of her son*s demise.

 

 

** When my doctor gave this to my son, I thought it was a light dose,**

she said. ** I had no idea that it was going to kill him. It ruined our

lives. ... There was no warning.**

 

 

Findings May Add Fuel to ADHD Drug Debate

 

 

In the study of 564 children and teens who died suddenly, researchers led

by Madelyn Gould of the New York State Psychiatric Institute and Columbia

University in New York City found that that those who died suddenly were

7.4 times more likely than not to have been taking the stimulant medications.

The results of the study are reported online in The American Journal of

Psychiatry.

 

 

** Although sudden unexplained death is a rare event,** the researchers

said, ** this finding should be considered in the context of other data

about the risk and benefit of stimulants in medical treatment.**

 

 

ADHD Medication Concerns Have Arisen in Past

 

 

Reports of cases of sudden unexplained death among children taking

stimulants for ADHD have raised concerns over use of the medications in the

past.

The U.S. Food and Drug Administration*s adverse event reporting system

identified 11 sudden deaths in pediatric patients taking methylphenidate -- the

active ingredient in Ritalin and other ADHD drugs -- from January 1995 to

February 2005.

 

 

While this rate of sudden death appears very low, the researchers there

may be more cases that go unreported.

 

 

In 2006, the issue saw two FDA advisory committees come to opposite

conclusions regarding the need to include a boxed warning of the risk of sudden

death on the labels of stimulants. Later that year, information was added

to the regular warnings section of the medication labels noting the

association between sudden death and stimulant use at standard doses in

children

with serious heart problems.

 

 

The companies that manufacture these medicines maintain that these

products are safe and that their risks are properly disclosed.

 

 

** Based on several reviews of these reports, the frequency of sudden

cardiac death in children and adolescents taking a stimulant medication at the

time of their death has not been shown to be higher than the incidence seen

in the general population,** Shire Pharmaceuticals, which produces

Adderall XR, said in a statement issued Friday before the study*s release.

 

 

A spokesperson for Novartis, the company that manufactures the ADHD drug

Ritalin, said that a review of the company*s safety data ** failed to detect

an increased risk in sudden cardiac death associated with [Ritalin] use.

** McNeil Pediatrics, the company that manufactures the ADHD drug Concerta,

had no comment when contacted by ABC News.

 

 

Still, the findings will likely reignite a debate within the medical

community over the safety and proper use of the popular medications.

 

 

** It is astonishing that these drugs are used so widely with children --

5 percent of the school-aged population on a daily basis,** said William

Pelham, professor of psychology, pediatrics and psychiatry at the State

University of New York at Buffalo. ** When this study is published, I suspect

that the professional and advocacy groups that continue to ignore the

accumulating evidence showing absence of benefit on long-term outcomes will

have

a more difficult time defending the widespread practice of using

stimulants as first line and sole treatment for ADHD in children.**

 

 

Controversy Remains Over Stimulant Drugs for ADHD

 

 

Other medical professionals said more research is necessary before making

any conclusions. ** As far as the study design goes, I*m reminded of the

old adage that *correlation is not causation*, ** said Jay Reeve, chief

executive officer of the mental health services organization Apalachee Center

Inc. in Tallahassee, Fla. ** The downside of this study may be a wholesale

rejection of the use of stimulants for children, which would be terrible.**

 

 

** While caution is an excellent practice in child psychiatry, too many

children are helped by the use of these meds ... to abandon prescribing these

meds entirely,** he said.

 

 

Daniel Cox, professor of psychiatry and neurosciences at the University of

Virginia in Charlottesville, agreed, adding that he fears the study will

have an overall negative effect on the health of these young patients if the

public misinterprets its findings.

 

 

** This article cannot address a possible large question: How many lives

are saved because of stimulant medications,** he said. ** How many children

do not impulsively run out in the street, are inattentive to a car

turning into their lane of traffic, don*t climb out on a roof and fall because

they are appropriately medicated and less impulsive and inattentive because

of the therapeutic effects?**

 

 

Still, Ann Hohmann said that the circumstances behind her son*s death are

hard to ignore.

 

 

** We didn*t know anything until we saw the death certificate, which said

* sudden cardiac death, myocarditis*, ** she said. ** When I

saw that, it blew me away. How can a healthy 9-year-old have a heart attack?

**

 

 

And while Shire noted that it provides warning language about the use of

these medicines by patients with serious heart problems, Ann Hohmann said

that her son had no such history.

 

 

** He had seen doctors several times prior to that, and he had a physical

a year before that. The last time he saw a doctor, they listened to his

heart.**

 

 

Keeping Kids With ADHD Safe

 

 

Last year, the American Heart Association recommended considering routine

heart screening tests known as electrocardiograms, or ECGs, prior to

starting children with ADHD on stimulant drugs and called for future studies to

assess the risk of sudden death.

 

 

Reeve said that he feels such testing could go a long way in determining

which children should not be taking the medications.

 

 

Some Support Heart Screenings for Kids on ADHD Drugs

 

 

** I think that the AHA recommendations on ECG screening made a lot of

good sense and go along with the idea that caution should be the first

standard in medicating children,** he said.

 

 

Not all doctors agreed, however. ** There is no evidence that suggests

doing [ECGs] on all children taking stimulant medication will decrease

incidences of sudden death,** noted Dr. Francisco Xavier Castellanos,

professor

of child and adolescent psychiatry at the New York University's Langone

Medical Center in New York City. ** What we need is to move from spasmodic

concern -- ** let*s do something fast ** -- to an urgency to get targeted

research going that will provide crucially needed knowledge about who is at

risk.**

 

 

As for Hohmann, she said that she has started telling her friends to make

sure that they do not put their children on stimulant ADHD medications. She

added that she would advise any parents who had children who were taking

an ADHD medication to have their children*s hearts checked on a regular

basis, both prior to beginning treatment with the drug and while they are

taking it.

 

 

**When you lose a child, it*s the most devastating thing you could ever,

ever go through,** she said. ** Something needs to be done.**

 

 

ABC News* Cathy Becker contributed to this report.

 

 

 

Copyright © 2009 ABC News Internet Ventures

~~~~~~~~~~~~~~~~~~

 

 

 

The Wall Street Journal, page D6

JUNE 16, 2009

FDA Cites Limitations of ADHD Drug Study

By JARED A. FAVOLE

 

 

The Food and Drug Administration on Monday said children shouldn*t stop

taking drugs that treat attention deficit hyperactivity disorder, or ADHD,

despite a study showing the stimulants may be associated with sudden death.

 

 

A study released in the American Journal of Psychiatry found an

association between the stimulants, which include drugs such as Ritalin, and

sudden

death in children who take the medicines.

 

 

The FDA, which partly funded the study, said there isn*t enough evidence

to conclude the drugs are dangerous and recommends people continue taking

their medications. The study compared 564 healthy children who died suddenly

to 564 who died in a motor-vehicle accident. The study found that two

patients in the motor-vehicle group were taking stimulants, while 10 in the

group of those who died suddenly were taking the medicines. The children died

between 1985 and 1996, before certain stimulants, such as Adderall, became

more commonly used.

 

 

** Given the limitations of this study*s methodology, the FDA is unable to

conclude that these data affect the overall risk and benefit profile of

stimulant medications used to treat ADHD in children,** FDA said.

 

 

One of the major limitations of the study, said FDA*s Robert Temple, was

that so few children who were studied were on stimulants.

 

 

These stimulants are aimed at helping kids and adults concentrate. Some

leading ADHD drugs include Shire Pharmaceuticals Group PLC's Adderall,

Johnson & Johnson*s Concerta, Eli Lilly & Co.*s Strattera and Novartis AG*s

Ritalin.

 

 

Dr. Temple said the FDA has had its eye on whether ADHD medications cause

heart problems and sudden death for years.

 

 

In 2006, the FDA required makers of ADHD drugs to update the drugs* labels

to warn of rare but increased risks for psychiatric problems, heart

attacks and strokes.

 

 

The FDA is conducting two more studies to determine the relation of ADHD

medicines to death and stroke. One involves children and should be completed

in the fall, while the other, in adults, likely won*t be released until

2010.

 

 

 

 

* Email Jared A. Favole at _jared.favole_

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