ADHD drugs safe, doctors say ahead of FDA panel

Drugs to treat attention deficit hyperactivity disorder, or ADHD, are generally safe, some doctors said on Thursday after U.S. health officials announced a meeting to discuss possible heart risks.

“It’s not a big deal for patients without a cardiac history,” Dr. Adelaide Robb, a psychiatrist at Children’s National Medical Center in Washington, told Reuters.

The Food and Drug Administration has scheduled a Feb. 9 meeting of outside advisors to weigh the risk of heart attack, high blood pressure and stroke associated with ADHD drugs, and to decide whether more studies are needed.

The FDA said the meeting was part of an ongoing review and was not triggered by specific new reports. “The FDA has no new information to suggest that the drugs may increase heart risk,” agency spokeswoman Susan Cruzan said.

“The few controlled clinical studies of longer term drug treatment of ADHD provided little information on cardiovascular risks,” the FDA said in a notice for the meeting.

There are different types of drugs to treat the disorder, in which people have trouble paying attention and may be hyperactive or impulsive.

One category, known as methylphenidates, includes Johnson & Johnson’s Concerta and Novartis AG’s Ritalin and Focalin.

Others, called amphetamines, include GlaxoSmithKline Plc’s Dexedrine and Shire Pharmaceuticals Group Plc’s Adderall and Dextrostat.


Drugs to treat the disorder have been around for decades, and overall help patients more than they harm them, several psychiatrists said.

“Everybody knows that these medications, at higher-than-normal doses can have effects on the heart,” Robb said.

She added that most doctors already watch for possible heart and other problems, but more data and possible label changes could help alert parents about the link.

Dr. Andrew Adesman, a behavioral pediatrician at New York’s Schneider Children’s Hospital, said the FDA panel was important, but that the heart risk doesn’t affect his practice.

“At this point we don’t have any credible data to suggest there’s any increased risk,” he said.

Others expressed concern that too many drug warnings about every possible side effect will make such alerts useless.

Last June, the FDA said it was planning to update ADHD drug labels with information about psychiatric problems following reports of suicidal thoughts and other psychiatric problems involving Concerta.

At the time, agency officials said the behavior may be tied to other medicines in the same family, and the FDA aimed to review data and report on the risk in early 2006.

FDA’s Cruzan could not immediately report on the progress of that review.

ADHD treatments already come with warnings about hallucinations, abnormal thinking and other mental problems.

Since then, Eli Lilly and Co. added a warning about suicidal behavior linked to Strattera, which already carried a warning about liver injury. In March, Abbott Laboratories Inc. pulled Cylert from the U.S. market, citing declining sales, but the FDA later said liver problems made it too risky.

Provided by ArmMed Media
Revision date: July 5, 2011
Last revised: by Jorge P. Ribeiro, MD