By STEPHANIE NANO, Associated Press Writer
Children should be screened for heart problems with an electrocardiogram before getting drugs like Ritalin to treat hyperactivity and attention-deficit disorder, the American Heart Association recommended Monday.
Stimulant drugs can increase blood pressure and heart rate. For most children, that isn't a problem. But in those with heart conditions, it could make them more vulnerable to sudden cardiac arrest — an erratic heartbeat that causes the heart to stop pumping blood through the body — and other heart problems.
About 2.5 million American children and 1.5 million adults take medication for attention-deficit hyperactivity disorder, or ADHD, according to government estimates. Stimulant drugs, like Ritalin, Adderall and Concerta, help children with ADHD stay focused and control their behavior.
The medications already carry warnings of possible heart risks in those with heart defects or other heart problems, which some critics said were driven more by concerns of overuse of the drugs than their safety.
The heart group is now recommending a thorough exam, including a family history and an EKG, before children are put on the drugs to make sure that they don't have any undiagnosed heart issues.
"We don't want to keep children who have this from being treated. We want to do it as safely as possible," said Dr. Victoria Vetter, a pediatric cardiologist at the University of Pennsylvania School of Medicine and head of the committee making the recommendation.
The label warnings were added after a review by the Food and Drug Administration of its databases found reports of 19 sudden deaths in children treated with ADHD drugs and 26 reports of other problems including strokes and fast heart rates between 1999 and 2003. There were also reports of heart problems in adults; the committee didn't look at adults.
An EKG can detect abnormal heart rhythms that can lead to sudden cardiac arrest. Children who are already on ADHD drugs should also be tested, Vetter said. If problems are found, the child should be sent to a pediatric cardiologist. With careful monitoring, Vetter said, children with heart problems can take the medicines if needed.
The cost of an EKG varies depending on who does it and the location. For example, the amount that Aetna Inc. pays for an EKG in a doctor's office ranges from $24 to $50; Medicare's payment rate is about $23. Vetter said Children's Hospital of Philadelphia, where she works, has been doing EKG screening for three years and it has been covered by insurance.
She said a screening of about 1,100 healthy children found that about 2 percent of them had some kind of heart problem.
"We thought it was reasonable to include the electrocardiogram as a tool for the pediatrician, the psychiatrist so that this would help identify additional children who have heart disease," Vetter said.
But Dr. Steven Pliszka, a child psychiatrist at the University of Texas in San Antonio, said he was baffled by the EKG recommendation. He said there's no evidence that sudden death is a bigger problem for children taking stimulants than for children who aren't taking the drugs.
Pliszka said an EKG might deter people from seeking treatment because it's an added expense and hassle. Psychiatrists aren't likely to have an EKG machine, and pediatricians might not either, making patients go elsewhere to get the test, he said.
The American Academy of Child and Adolescent Psychiatry recently updated its treatment guidelines for ADHD, and did not recommend routine EKGs, said Pliszka, who was the lead author. He has received research support or served as a consultant for makers of ADHD drugs.
"We definitely did not feel we needed to screen everyone," Pliszka said.
He noted that the heart association doesn't recommended EKG screening for young athletes to prevent sudden death. The group has said it wasn't feasible or cost-effective to screen all student athletes.
Representatives for Shire PLC, which makes Adderall and two other ADHD treatments, and Norvartis Pharmaceuticals Corp., which makes Ritalin, said the labeling already suggests patients be evaluated for heart problems and an EKG done if needed.
"There's no new information here. And frankly, we're a little perplexed as to the purpose of the American Heart Assocation coming out with this statement at this time," said Shire spokesman Matt Cabrey.
An ADHD advocacy group called CHADD said parents should monitor their child's reaction to all medications. EKG screening "will bring an even further measure of safety to what is already a safe clinical treatment approach," the group said.
On the Net:
ADHD drugs: http://www.parentsmedguide.org/
American Heart Association: http://www.heart.org/
August 10, 2008
Heartwire 2008. © 2008 Medscape
August 1, 2008 — The American Academy of Pediatrics (AAP) has issued a new policy statement emphasizing that routine ECGs for children receiving medications for attention-deficit/hyperactivity disorder (ADHD) are not warranted . The statement comes after advice given by American Heart Association (AHA) earlier this year , that physicians consider ordering an ECG to aid them in deciding whether or not underlying heart disease is present before prescribing ADHD drugs.
A spokesperson for the AHA told heartwire that in May/June it "clarified" its original advice, issued in April, in a joint advisory from the AHA and the AAP , saying that an ECG should be at the physician's discretion and it is not mandatory to obtain one. The AHA also updated its original statement . "Our recommendations have not changed since we issued them this spring. Rather, we issued a clarification as a result of confusion and concern among the public and healthcare professionals. Routine use of ECGs to assess these children has not ever been part of our recommendations," the spokesperson said.
The current statement from the AAP, published in the August 2008 issue of Pediatrics, formalizes its position on the issue, an AAP spokesperson told heartwire. However, the two organizations still seem somewhat out of kilter on the strength of the advice they are issuing, with the AHA still more strongly recommending the use of an ECG than the AAP.
The AHA makes the following recommendations for children starting ADHD medications:
- A thorough patient and family history should be obtained for assessment of these children. This is a class I recommendation (using the ACC/AHA classes of recommendations and levels of evidence).
- Acquiring an ECG is a class IIa recommendation. This means it is reasonable for a physician to consider obtaining an ECG as part of the evaluation. It is not mandatory, but rather is left to the physician's discretion. Treatment of a patient with ADHD should not be withheld because an ECG is not done. The child's physician is the best person to assess whether there is a need for an ECG.
- It is reasonable to use ADHD medications with caution in patients with known congenital heart disease and/or arrhythmias if these patients are stable and under the care of a pediatric cardiologist.
Latest AAP Statement
The latest AAP statement says that the AHA's recommendation to obtain an ECG before starting medications to treat ADHD "contradicts the carefully considered and evidence-based recommendations of the American Academy of Child and Adolescent Psychiatry and the American Academy of Pediatrics." It notes that these organizations have concluded that sudden cardiac death in people taking medications for ADHD is a very rare event, occurring at rates no higher than those in the general population of children and adolescents. It also notes that it has not been shown that screening ECGs before starting stimulants have an appropriate balance of benefit, risk, and cost-effectiveness for general use in identifying risk factors for sudden death. "Until these questions can be answered, a recommendation to obtain routine ECGs for children receiving ADHD medications is not warranted," the statement concludes.
The AAP statement adds that the authors of the AHA statement acknowledge the lack of evidence showing a benefit of routine ECG screening for these children, but still assigned their recommendation for screening a IIa classification (weight of evidence/opinion is in favor of usefulness/efficacy) and a category C level of evidence (only consensus opinion of experts, case studies, or standard of care). The AAP disagrees with both of these classifications. "Using AHA criteria, the AAP would, at most, classify this recommendation as IIb ('the level of evidence is less well established by evidence/opinion . . . . Additional studies with broad objectives needed'). In addition, using the AAP classification of recommendations, the AAP would assign the recommendation a category D level of evidence (on the basis of expert opinion without even observational studies)," the statement says, adding that the AAP avoids making guideline recommendations with a category D level of evidence.
It further claims that expert opinion suggests that the harm outweighs the benefit of recommending routine ECGs for healthy children who are starting stimulant medication for ADHD. "Accordingly, the AAP would recommend against such routine ECG screening," the statement concludes.
The AAP makes the following recommendations:
- Careful assessment of all children, including those starting stimulants, using a targeted cardiac history (eg, patient history of previously detected cardiac disease, palpitations, syncope, or seizures; a family history of sudden death in children or young adults; hypertrophic cardiomyopathy; long QT syndrome) and a physical examination, which includes a careful cardiac examination (evidence quality: C; strength: recommendation). If patient history, family history, or physical exam is suggestive of cardiac disease, further evaluation is advised, with input from a pediatric cardiologist.
- Given current evidence, the AAP encourages primary care and subspecialty physicians to continue currently recommended treatment for ADHD, including stimulant medications, without obtaining routine ECGs or routine subspecialty cardiology evaluations for most children before starting therapy with these medications (evidence quality: D; strength: option).
- More research is needed on risk factors for sudden cardiac death among all children and adolescents, including those with ADHD who are treated with stimulant medications. Better methods of detecting hidden cardiac disease in children should be another focus of such research efforts.
Nissen Disagrees with AAPBut cardiologist Dr Steven Nissen (Cleveland Clinic, OH) says the AAP statement is misguided. He commented to heartwire: "It suggests that as many as 8% of children should be treated with amphetamines or related stimulant drugs. These drugs increase blood pressure and have not been studied in long-term trials. The statement asserts that sudden death is not more common in children receiving these drugs. However, the FDA has issued a warning for all of the ADHD drugs that states that they can cause sudden death at usual doses. It is irresponsible for a professional medical society to recommend to its members that they ignore an FDA-mandated warning. This is the second time in a few weeks where the AAP has issued poorly thought out guidelines that promote inappropriate drug use in children. The previous statement promoted statin use in children as young as 8 years of age."