ADHD Drugs Need Better Warnings on Heart, Psychiatric Risks: FDA

All meds must now come with patient guideline inserts, agency says.

By Amanda Gardner
HealthDay Reporter
Wednesday, February 21, 2007; 12:00 AM

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WEDNESDAY, Feb. 21 (HealthDay News) -- U.S. health officials on Wednesday told manufacturers of all drugs used to treat attention-deficit hyperactivity disorder that they must develop patient medication guides warning of possible cardiovascular and psychiatric risks.

"We issued letters earlier today to manufacturers of all the ADHD products asking them to implement medication guides to alert patients and their families to certain risks that may be associated with these drugs when taken at usual doses," Dr. Tom Laughren, director of the psychiatry products division at the Center for Drug Evaluation and Research with the U.S. Food and Drug Administration, said at a Wednesday teleconference.

Experts hailed the move.

"A warning like this is important because it makes people think twice before they do this, and it stimulates more investigation," said Dr. Steven Lipshultz, chairman of the pediatrics department at the University of Miami Miller School of Medicine. "I think this is excellent, and can only be beneficial."

According to the FDA, ADHD affects 3 percent to 7 percent of school-aged children and about 4 percent of adults. An estimated 2.5 million U.S. children and 1.5 million adults now take medications for the treatment of ADHD -- a field that has seen its share of controversy.

Spiraling growth in use of these medicines -- the number of adults aged 20 to 44 using ADHD drugs surged more than 139 percent from 2000 to 2005 -- has already prompted safety questions.

One drug, Strattera, is now required to carry a black box warning that it might prompt suicidal thoughts in children. Last year, Health Canada briefly pulled another drug, Adderall, from the market because of reported cardiac risks. And in the United States, Adderall XR carries a warning that patients with heart conditions should not use the drug.

Last year, an FDA pediatric advisory panel recommended against putting black box warnings about psychiatric and cardiac risks on ADHD drugs. Instead, the panel recommended that the medications use simpler language and include more information on the label.