[NYAPRS Enews] ABC News: Study Links ADHD Drugs to Sudden Death in Children

[Matt Canuteson]

ADHD Drugs Linked to Sudden Death

Some Parents Believe New Study Reinforces Link Between Stimulants,
Cardiac Death

 

By Dan Childs and Todd Neale ABC News 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
<http://abcnews.go.com/Health/story?id=3855328&page=1> , or ADHD
<http://abcnews.go.com/Health/story?id=3855328&page=1> . And like an
estimated 2.5 million other children
<http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5434a2.htm>  in the United
States, he was taking medication
<http://abcnews.go.com/Health/MindMoodNews/story?id=7424298&page=1>  for
the condition. 

It was Ann Hohmann who gave Matthew his Adderall XR
<http://abcnews.go.com/Health/Diet/story?id=4515712&page=1>  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
<http://abcnews.go.com/Health/Cholesterol/story?id=2507842&page=1>  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. 

Currently, however, it appears unlikely that this new study will have an
effect on the FDA's approach to these drugs. 

"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," the FDA said in a
statement released this morning. "Therefore, the FDA believes that this
study should not serve as a basis for parents to stop a child's
stimulant medication. Parents should discuss concerns about the use of
these medicines with the prescribing healthcare professional." 

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." 

 

http://abcnews.go.com/Health/MindMoodNews/story?id=7829005&page=1

 

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