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Study
Shows Possible Link Between Deaths and ADHD Drugs
By
Shankar Vedantam
Washington Post Staff Writer
Tuesday, June 16, 2009
Children taking stimulant
drugs such as Ritalin to treat attention-deficit hyperactivity
disorder are several times as likely to suffer sudden, unexplained
death as children who are not taking such drugs, according to a
study published yesterday that was funded by the Food and Drug
Administration and the National Institute of Mental Health.
While the numbers
involved in the study were very small and researchers stopped short
of suggesting a cause and effect, the study is the first to
rigorously demonstrate a rare but worrisome connection between ADHD
drugs and sudden death among children. In doing so, the research
adds to the evolving puzzle parents and doctors face in deciding
whether to treat children with medication.
Doctors have speculated
about such a connection in the past because stimulants increase
heart rate and have other cardiovascular effects. Physicians are
currently advised to evaluate patients for cardiac risks before
prescribing the drugs, and FDA officials said yesterday that those
guidelines do not need strengthening in light of the new study.
About 2.5 million children in the United States take ADHD
medications such as Ritalin and Adderall.
In a press briefing
called on short notice yesterday, FDA officials said 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, a professor in child psychiatry and epidemiology at Columbia
University, said she agreed with the FDA's advice.
"This study reports a
significant association or 'signal' between sudden unexplained death
and the use of stimulant medication, specifically methylphenidate,"
the study researchers concluded, referring to the chemical name of
Ritalin. "While the data have limitations that preclude a definitive
conclusion, our findings draw attention to the potential risks of
stimulant medications for children and adolescents."
Since an experimental
study comparing the risk of sudden death among children taking
medications with those not taking medications would have had to
include millions of children to generate a useful scientific result,
Gould and a number of colleagues conducted what is known as a
matched case-control study: They obtained information about 564
children in the United States who died suddenly and inexplicably
between 1985 and 1996. The researchers evaluated how many of the
children who died had been taking stimulant drugs by asking their
parents and caregivers and by reviewing medical documents.
For every child who died
suddenly and inexplicably, the researchers then found another child
closely matched in terms of age, sex and other variables who died in
a traffic accident. Taking a stimulant drug is unlikely to have
played any role in a child getting killed in an accident. If
stimulant drugs had nothing to do with sudden, unexplained death,
then the number of victims on stimulant drugs who suffered such
deaths and the number of victims on stimulant drugs who died in
traffic accidents ought to have been about the same.
But 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.
Robert Temple, director
of the Office of Drug Evaluation at the Center for Drug Evaluation
and Research at the FDA, said that the study had been well
conducted, but that he was concerned that not all parents may
accurately recall whether children who died were taking stimulant
drugs. When a child dies suddenly, he said, it is natural for a
parent to pay close attention to all the medications the child was
taking at the time and to report that to researchers. By contrast,
he said, parents whose children die in traffic accidents may be less
likely to note whether their children are taking medications -- and
less able to report it years later.
In an editorial
accompanying the study, Benedetto Vitiello of the National Institute
of Mental Health said that ADHD itself might have increased the risk
for sudden, unexplained death. If that were the case, he said, it
would explain why more children taking stimulant drugs were found in
the group that suddenly died than among the children who died in
traffic accidents.
The researchers who
conducted the peer-reviewed study acknowledged that its design
precluded definitive answers, but they said that they had taken care
to eliminate each of these potential confounders. They did not
consider cases of sudden death in which children had asthma or
cardiac abnormalities -- conditions known to be associated with ADHD
-- because those factors might have independently raised the risk of
sudden death. They also included one child who died in a traffic
accident who seemed to have been abusing amphetamines, rather than
taking an ADHD medication.
Gould said she had her
colleagues had compensated for biases not only on the part of
parents, but in medical records -- medical examiners are more likely
to conduct toxicology tests among children who die suddenly than
among children who die in traffic accidents. The researchers first
eliminated all records that relied on parental memories and looked
only at medical records. They then eliminated all cases that had
medical records and looked only at what parents reported. No matter
how the data were sliced, Gould said, there were significantly more
children taking stimulant drugs who suffered sudden, unexplained
death than those were killed in traffic accidents.
Vitiello said Gould's
study underscores that ADHD drugs are not innocuous. Indiscriminate
prescription of the drugs for general behavioral problems and the
growing number of healthy teenagers and adults using the drugs to
boost mental performance could have deadly consequences, he added.
http://www.washingtonpost.com/wp-dyn/content/article/2009/06/15/AR2009061502833.html?hpid=moreheadlines
June 16, 2009b
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