Heart exam, EKG recommended before children get ADHD drugs

[Wackerdan]

Heart exam, EKG recommended before children get ADHD drugs

By STEPHANIE NANO – 16 hours ago

NEW YORK (AP) — 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

National Resource Center on ADHD: http://www.help4adhd.org

[Wackerdan]

New Heart Alert for Some ADHD Drugs

Strongest Warning Focuses on Amphetamine-Based Drugs

By Miranda Hitti

WebMD Medical NewsReviewed by Michael W. Smith, MDAug. 22, 2006 -- Amphetamine-based drugs for ADHD, such as Adderall and Dexedrine, now come with a new, expanded 'black box' warning for an increased risk of sudden death in patients with heart problems.

A black box warning is the most serious warning added to a drug's label information.

Earlier this year, two FDA advisory panels recommended new warnings and information for all stimulant drugs used to treat attention deficit hyperactivity disorder (ADHD). But the panels didn't quite agree on the warnings.

In February, one panel recommended a black box warning. But, in March, a separate panel stopped short of recommending the black box warnings.

Since Adderall and Dexedrine are amphetamines, they already had a black box warning about amphetamine abuse.

That black box warning for the two drugs now includes the following sentence: "Misuse of amphetamines may cause sudden death and serious cardiovascular events." Notice of the warning for Dexedrine appeared on the FDA's site yesterday.

Ritalin and Concerta, two other drugs used to treat ADHD, aren't amphetamines. So they don't bear the black box warning about amphetamine use.

However, they are stimulants and do carry warnings about the risk of sudden death in people with heart problems. The FDA has not decided these drugs need to carry a black box warning.

Ritalin is made by Novartis. Concerta is made by McNeil Pediatrics. Adderall is made by Shire. Dexedrine is made by GlaxoSmithKline. All are WebMD sponsors.

ADHD Drug Warnings

Warning information for all stimulant ADHD drugs includes the following:

Sudden death has been associated with stimulants at usual doses in children and teens with structural heart abnormalities or other serious heart problems.

Children, teens, or adults who are being considered for treatment with stimulant medicines should have a careful checkup (including family history and a physical exam) to check for heart disease.

Patients who develop symptoms such as chest pain during exertion, unexplained fainting, or other possible heart symptoms should promptly get a heart evaluation.

Sudden death, stroke, and heart attack have been reported in adults taking stimulant drugs at usual doses for ADHD.

Adults are more likely than kids to have serious structural heart abnormalities, cardiomyopathy(a disease of the heart muscle), serious heart rhythm abnormalities, coronary artery disease, or other serious heart problems.

Adults with such heart abnormalities should also generally not be treated with stimulant drugs.

GlaxoSmithKline, maker of Dexedrine, said in a letter posted on the FDA web site that it added the warning based on recommendations from the FDA advisory committees.

WebMD contacted the makers of Ritalin, Concerta, and Adderall for their comments.

In a statement emailed to WebMD, McNeil Pediatrics spokeswoman Julie Keenan confirmed that McNeil Pediatrics has worked with the FDA to update the warnings section of the prescribing information for Concerta extended-release tablets.

The update was "based on recommendations regarding use of stimulant medications to treat ADHD from two FDA advisory committee meetings," Keenan says.

"We encourage parents whose children use Concerta to contact their physician if they have any questions," she adds.

The makers of Ritalin and Adderall didn't respond before deadline.

The ADHD drug Strattera isn't a stimulant, so it doesn't carry the same warnings. Strattera is made by Eli Lilly and Company, also a WebMD sponsor.

View Article Sources

SOURCES: News release, FDA. GlaxoSmithKline: "Important Prescribing Information," Letter to Doctors, Aug. 4, 2006. Novartis: "Prescribing Information for Ritalin." McNeil Pediatrics: "Prescribing Information for Concerta." Shire: "Prescribing Information for Adderall." WebMD Medical Reference from Healthwise: "Pediatric Cardiomyopathy." WebMD Medical News: "Experts Urge Stern ADHD Drug Warnings." WebMD Medical News: "New Warnings Urged for ADHD Drugs." Julie Keenan, spokeswoman, McNeil Pediatrics.

[AZCEP]

Hey, what do you know? I didn't think I'd live to see the day that the FDA put out something that acutally made sense.

Way to go Feds! :roll:

[Dustdevil]

Seriously. Although, I am a bit surprised to hear that there is no evidence of children on stimulants being at risk. I'd feel better if I could see some research on that.

As for the complaint that the cost of an EKG might dissuade some from getting the treatment, I have to call BS on that. I bet the incidence of families without some sort of insurance seeking ADHD treatment is pretty darn low. It's not just an economic thing. It's a social thing.

[AZCEP]

http://www.medscape.com/viewarticle/555229...&uac=4700ER

Stimulant Abuse May Increase Stroke Among Young Adults

There you go Dust. That should appease you for now.

[rock_shoes]

I think it's a great idea to put kid's through some testing prior to putting them on stimulant medications. All in all these medications are way over prescribed. More often than not ADHD can be controlled through behavioral methods. Having been on Dexedrine for ADHD myself I can assure you these medications aren't the cure all many would have you believe. The side affects can be terrible.