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Warning worries parents of ADHD kids

Cheri Flores' middle son set fires, smashed furniture and brandished knives before he started taking medicine for attention deficit hyperactivity disorder.

"He was getting kicked out of school every other day," said Flores, 35, of Inverness. "Medication saved him."

Now the federal Food and Drug Administration may put strong warning labels on medications like the one Flores' son and millions of others take because of concerns that these stimulants may be linked to heart problems experienced by some patients.

For many parents, the news has created fresh worries. They have been calling their doctors and schools, asking if the medicines intended to help their children could end up hurting them.

For Flores, the medicine has proved so effective in helping her 12-year-old son's behavior that she already knows she wants to continue it. In fact, one of her other sons takes the same medicine.

"Taking my kids off these medications would be setting them up for failure," Flores said.

Others are not so sure.

"I had several parents go back to their children's doctors," said Dave Stone, director of Center Academy in Riverview, where about 60 percent of the children have been diagnosed with ADHD or ADD. "Some of them changed their medications. Some of them were assured the medications they were on were not going to harm them."

The risk of heart problems is small compared to the benefits of medication for children with ADHD, said three Florida child psychiatrists.

Dr. Mark Cavitt, medical director of pediatric psychiatry services at All Children's Hospital in St. Petersburg, has 500 to 600 patients who take Ritalin or a similar drug. Several have contacted him since the news came out, he said, but nobody has decided to take a child off the drug after talking it over.

"It's a point of concern," Cavitt said. "Parents need to be aware and physicians need to talk to parents . . . but it shouldn't necessarily rule out using psycho-stimulant medication. Because if ADHD goes untreated, it has risk factors too."

Children with untreated ADHD are more likely to have accidental injuries, experiment with drugs and have other behavioral problems, said Cavitt and other psychiatrists.

"People need to get the whole picture," said Dr. Elias Sarkis, associate clinical professor of child psychiatry at the University of Florida. "ADHD can be a devastating disorder with really bad consequences, or it can be treated with medications . . . and people can be very productive."

ADHD is the most frequently diagnosed mental health condition in American children, according to the American Psychiatric Association. Children with the disorder may be impulsive, unable to focus and hyperactive.

Stimulants such as Ritalin are designed to affect behavior by increasing the level of certain chemicals in the brain, such as dopamine, to make it easier for people to regulate their behavior.

About 2.5-million children between age 4 and 17 take ADHD drugs, according to federal survey data cited by the FDA.

Doctors say the medication needs to be prescribed on a case-by-case basis. Although some children with ADHD display disruptive behavior, others do not, and some children with ADHD may have other disorders as well, such as anxiety or depression, which also need treatment.

An advisory committee to the federal Food and Drug Administration recently voted to place a "black box" warning on the medicines, which include Ritalin, Concerta, Methylin and Metadate. The recommendation came after the committee heard about the deaths of 25 people, including 19 children, who had been taking the medications.

But even then, it was a close decision. The committee vote to recommend the warning label was 8-7, with one abstention, and all sides agree more study is needed. The FDA has not yet decided whether to adopt the recommendation, but it typically follows the advice of its advisory committees.

The medicines Adderall and Adderall XR, which are both amphetamines, already carry strong warnings. The heart risk warning would not be placed on Strattera, which is not a stimulant.

Dr. Esther Gonzalez, a pediatrician who runs the Comprehensive Behavioral Institute in Crystal River, knows parents are keenly aware of the warning label debate.

"Lots of people called here and were worried their kids would die," Gonzalez said.

Gonzalez and other doctors said they look at whether children have any history of heart problems before putting them on medication.

Compared to the large number of children taking the medicine, the risk of death is low, said Dr. Saundra Stock, assistant professor of psychiatry at the University of South Florida College of Medicine.

"I think a black box box warning for such rare events serves mostly to scare people," Stock said. "And delay treatment rather than benefiting the public."

Sarkis said more study is needed, but at this point, a warning label isn't.

Still, the drugs are known to increase pulse and blood pressure. In most people, the change is slight. But in a child with a real heart problem, perhaps some undiagnosed congenital defect, that increase could trigger heart problems, Cavitt said.

Even so, some studies suggest that the rate of sudden cardiac arrest may even be lower in people taking Ritalin than in the general population, Cavitt and Sarkis said.

About 70 percent of people with ADHD respond to Ritalin and other stimulants. Parents who have seen the drug make a difference are unlikely to drop it, Stock said.

"Most parents who have seen a positive response are continuing them on the medication," she said. "Only those who are taking it and not seeing a clear benefit are going to stop, I think."

Flores said parents and teachers need to be paying close attention to their children also. "They can tell if they're failing, can pay attention, are able to do their work," she said.

She has three sons who take ADHD medicines. Two of them take Metadate, one of the medicines that would be covered by the new warning labels. Her own experience has been positive.

Of her middle son, she said, "It's wonderful. No more broken furniture, knives, fire. He smiles. He's happy."



+ Don't panic. The risk of heart problems is extremely low compared with the number of children taking medication.

+ If your child has a heart problem or a family history of sudden cardiac death, discuss this with your doctor. Doctors might stop the medication, or do more testing to make sure your child is at low risk.

+ Some doctors recommend testing for hidden heart problems before the medication is prescribed. Consult your physician.

Source: Dr. Mark Cavitt, medical director of pediatric psychiatry services at All Children's Hospital in St. Petersburg