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FDA Panel Rejects Strongest Warning for ADHD Drugs

Instead calls for simpler language and more information on labeling

WEDNESDAY, March 22, 2006 (HealthDay News) -- Drugs used to treat attention-deficit hyperactivity disorder should not carry the strongest warnings possible about the psychiatric and cardiac risks they can pose, a federal panel recommended late Wednesday.

The U.S. Food and Drug Administration's pediatric advisory committee reached a consensus that, instead of a "black box" warning, the medications should use simpler language and include more information on the labels.

Just last month, a different FDA advisory committee reached the opposite conclusion when it called for a "black box" warning on ADHD drugs because of possible cardiac risks.

Wednesday's news casts doubt on whether the federal agency will require "black box" warnings on all ADHD drugs. It typically follows the recommendations of its committees, but in this case there are areas of disagreement.

"The [pediatric] committee was skeptical about suicidality," Robert Temple, director of the FDA's Center for Drug Evaluation and Research, said at a news conference after the panel's day-long hearing. "We still have to come to grips with some of the recommendations made at the drug safety committee one-and-a-half months ago, but that pertained mostly to adults. The committee today was not impressed with the general cardiovascular risks for children, except in people with underlying heart disease... It was quite a satisfactory meeting that answered many of our questions, but we still have much work to do on adults."

Under consideration has been all marketed drugs for ADHD, including amphetamines (Adderall XR), methylphenidates (Ritalin, Concerta and Metadate) and the non-stimulant Strattera, along with Sparlon, a narcolepsy drug that is being considered as a treatment for ADHD. A separate FDA advisory committee will consider a new drug application for Sparlon's use as an ADHD drug on Thursday.

"These medications all have side effects, and the new alarm is just that they're trying to figure out whether the risk-benefit ratio is worth taking the risk," said Dr. Eugenio Rothe, an associate professor of psychiatry at the University of Miami School of Medicine.

During the hearing, psychiatrists urged the panel members to move cautiously in considering stronger warnings about rare but serious risks, contending that "black-box" warnings on some or all the drugs could cause more harm than good.

"I suggest confusion, polarizing viewpoints, initial press hysteria. But then what?" Julie Zito, associate professor in pharmacy and psychiatry at the University of Maryland, asked the panel according to the Associated Press.

"Black box warnings turn off some parents," said Dr. Karen Ballaban-Gil, a professor of clinical neurology and clinical pediatrics at Albert Einstein College of Medicine and Montefiore Medical Center in New York City. "There are [also] healthcare providers who will be more reluctant to prescribe stimulant medication if there is a black box warning."

Theoretically, any recommendation could eventually affect a large number of people: Some 2.5 million children and 1.5 adults now take ADHD medications. And some experts, including Dr. Lenard Adler, director of the Adult ADHD Program at New York University Medical Center and author of the forthcoming Scattered Minds: Help and Hope for Adults with ADHD, believe the condition is undertreated.

But even if more restrictive labeling is eventually recommended, experts say prescribing practices in this country won't necessarily change.

"People who are trained and comfortable and have knowledge about treatment are not going to change practice," said Ballaban-Gil. "People who are less comfortable may be more reluctant."

On the positive side, labeling changes could spur better care of people who use various ADHD medications.

"We know that these drugs cause changes in blood pressure and pulse that are relatively minor," Adler said. "These are areas where physicians and patients need to be aware. It's appropriate for them to have blood pressure and pulse monitored."

Controversy in this area is nothing new. Spiraling growth in use of the medicines -- the number of adults aged 20 to 44 using ADHD medications surged more than 139 percent from 2000 to 2005 -- has raised new 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 Adderall from the market because of reported cardiac risks. In the United States, Adderall XR carries a warning telling patients with heart conditions not to use the drug.

But there are also risks to not using the medications, one expert said.

"Nothing else has been shown to be as effective from an academic standpoint as stimulant medication [such as Ritalin]," Ballaban-Gil said. "Untreated ADHD puts children at risk, when they become young adults, for at-risk behavior, particularly substance abuse."

"There are substantial risks in not being treated," Adler added. "Adults with ADHD are twice as likely to be unemployed and divorced. They underperform on the job. They're more likely to smoke cigarettes and have substance-abuse issues."

For now, stimulants, with all their risks and benefits, are the "gold standard against which all other [ADHD] medications are compared," Ballaban-Gil said.

More information

The National Institute of Mental Health has more on ADHD.

SOURCES: March 22, 2006, news conference with Robert Temple, director, Center for Drug Evaluation and Research, Food and Drug Administration; Lenard Adler, M.D., director, Adult ADHD Program, New York University Medical Center, associate professor, psychiatry and neurology, New York University School of Medicine, New York City and author, Scattered Minds: Help and Hope for Adults with ADHD; Karen Ballaban-Gil, M.D, professor, clinical neurology and clinical pediatrics, Albert Einstein College of Medicine and Montefiore Medical Center, New York City; Eugenio M. Rothe, M.D., director, child and adolescent psychiatry clinic, Jackson Memorial Hospital, and associate professor, psychiatry, University of Miami School of Medicine
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