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

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

WEDNESDAY, Feb. 21, 2007 (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.

A month before that, however, another FDA advisory committee, the Drug Safety and Risk Management Committee, reached the opposite conclusion when it called for a black box warning on ADHD drugs because of possible cardiac risks.

The FDA essentially followed the advice of the pediatrics committee, and new warning language was incorporated into the labels by last fall.

Wednesday's action is also a result of those meetings last year.

"It has taken us longer to develop language for the medication guides, and we expect that the companies will quickly implement the new language," Laughren said. In fact, companies have 30 days to comply with the directive.

The patient medication guides address two areas of concern.

The first is cardiovascular adverse events in patients with underlying heart problems or defects, along with reports of stroke and heart attack in adults with certain risk factors.

"It's possible that the events might have been caused by the underlying disease, but the advisory committees advised us to alert clinicians to the possibility that the drugs might have had a role," Laughren said.

The second area of concern involves psychiatric events, primarily psychotic symptoms such as hallucinations or delusional thinking or the emergence of manic symptoms, even in patients who have no history of psychiatric problems. The occurrence of these events is roughly one in 1,000 people treated.

Officials hope that the guides, which are given to patients at the time the drug is dispensed, will alert doctors and patients to the importance of taking a careful medical history, doing a physical exam, and carefully monitoring patients for symptoms that may indicate a problem.

The medications affected by the action include Adderall, Adderall XR, Concerta, Daytrana, Desoxyn, Dexedrine, Focalin, Focalin XR, Metadate CD, Methylin, Ritalin, Ritalin SR, Ritalin LA and Strattera.

Laughren emphasized, however, that ADHD drugs do provide real benefit for certain patients.

"In no way do we consider this a general prohibition against using these drugs," he said. "We view the drugs as quite safe and effective, and in no way are we trying to inhibit appropriate prescribing."

"We just want prescribers and patients to be aware of certain risks, so patients can be safely treated," he added.

More information

View drafts of the patient medication guides at the U.S. Food and Drug Administration.

SOURCES: Feb. 21, 2007, teleconference with Tom Laughren, M.D., director, division of psychiatry products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration; Steven Lipshultz, M.D., professor and chairman, department of pediatrics and dean of child health, University of Miami Miller School of Medicine
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