FDA urges caution in weighing risks of ADHD drugs

Jun 15, 2009 By MATTHEW PERRONE , AP Business Writer

(AP) -- Federal health regulators are urging parents to keep their children on attention deficit drugs like Ritalin and Adderall, despite new evidence from a government-backed study that the stimulants can increase the risk of sudden death.

Published Monday in the American Journal of Psychiatry, the study suggests a link between use of the stimulant drugs and sudden death in children and adolescents. The drugs, used to treat attention deficit and hyperactivity disorder, already carry warnings about risks of heart attack and stroke in children with underlying heart conditions, but researchers have questioned whether they pose the same risks to children without those problems.

Healthy children taking the medications were more likely to die suddenly for unexplained reasons than those not taking the drugs, according to the study from the National Institute of Mental Health.

The study was partially funded by the , but agency experts said its methods - which relied on interviews with parents and physicians years after the children's deaths - may have caused errors.

"Since the deaths occurred a long time ago, all of this depended on the memory of people - relatives and physicians - involved with the victims," said Dr. Robert Temple, the FDA's director of drug review.

The agency urges parents to discuss safety concerns with their doctor, but to keep children on the treatments.

The study compared a sample of 564 children who died of unexplained causes to 564 children who were killed in car accidents. Among the unexplained deaths, 10 children were taking an ADHD compared with two of the patients killed in car accidents.

The researchers used car accident victims as a comparison group because sudden childhood deaths are rare and difficult to track.

"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," the authors conclude.

But the FDA said it is collecting data for a larger, more in-depth study of the drugs that should be completed by the fall.

"We're not sure this study tells us something we didn't know," Temple said of Monday's publication. "We didn't think it gave an unequivocal answer as to whether there is such a risk."

About 2.5 million U.S. children currently take drugs for ADHD, according to government researchers. The American Heart Association recommends doctors consider giving children echocardiograms before starting them on ADHD drugs, though experts stress there is little hard data about the drugs' risks.

Sales of the drugs topped $4.8 billion last year, according to health care analysis firm IMS Health. The most popular brands include Shire's Adderall, Johnson & Johnson's Concerta and Novartis' Ritalin.

©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Explore further: Study finds sharp rise in opioid treatment among pregnant women

add to favorites email to friend print save as pdf

Related Stories

Pediatric Ritalin may affect young brains

Jul 18, 2007

U.S. medical researchers have discovered use of the attention deficit hyperactivity disorder drug Ritalin by young children might affect their brains.

Epilepsy drug may increase risk of autism in children

Dec 01, 2008

A new study shows that women who take the epilepsy drug valproate while pregnant may significantly increase their child's risk of developing autism. The preliminary research is published in the December 2, 2008, print issue ...

FDA weighs approval of psychiatric drugs for kids

Jun 05, 2009

(AP) -- Three blockbuster psychiatric drugs currently approved for adults also appear to work in adolescents, though federal health officials have concerns about exposing younger patients to the drugs' side effects.

ADHD medications do not cause genetic damage in children

Nov 19, 2008

In contrast to recent findings, two of the most common medications used to treat attention deficit hyperactivity disorder (ADHD) do not appear to cause genetic damage in children who take them as prescribed, according to ...

Study links ADHD medicine with better test scores

Apr 27, 2009

(AP) -- Children on medicine for attention deficit disorder scored higher on academic tests than their unmedicated peers in the first large, long-term study suggesting this kind of benefit from the widely ...

Recommended for you

FDA proposes accelerated medical device approval plan

21 hours ago

(HealthDay)—The U.S. Food and Drug Administration has proposed a new program that would provide expedited access to high-risk medical devices intended for patients with serious conditions whose medical ...

Targeting drugs to reduce side effects

Apr 23, 2014

(Medical Xpress)—Consider ice cream – the base of which is frozen cream. Ingredients are then added to make different flavours. All these flavours are distinctly different but are created from the same foundation.

User comments : 0

More news stories

New breast cancer imaging method promising

The new PAMmography method for imaging breast cancer developed by the University of Twente's MIRA research institute and the Medisch Spectrum Twente hospital appears to be a promising new method that could ...

Breast cancer replicates brain development process

New research led by a scientist at the University of York reveals that a process that forms a key element in the development of the nervous system may also play a pivotal role in the spread of breast cancer.

Research proves nanobubbles are superstable

The intense research interest in surface nanobubbles arises from their potential applications in microfluidics and the scientific challenge for controlling their fundamental physical properties. One of the ...

Using antineutrinos to monitor nuclear reactors

When monitoring nuclear reactors, the International Atomic Energy Agency has to rely on input given by the operators. In the future, antineutrino detectors may provide an additional option for monitoring. ...