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FDA Told to Delay ADHD Drug Labeling Changes

Advisory panel suggests more safety data be gathered before any warnings are made

FRIDAY, July 1, 2005 (HealthDay News) -- An advisory committee told federal health officials Thursday that it was hesitant to recommend a labeling change for a class of stimulants used to treat attention-deficit hyperactivity disorder (ADHD).

A release posted on the U.S. Food and Drug Administration's Web site noted that members of the Pediatric Advisory Committee, in a meeting Thursday, did not come across any new concerns about psychiatric side effects with Concerta and other methylphenidates, which include Ritalin and Metadate. Panel members also suggested that the FDA wait until more safety data have been collected on two other types of drugs used to treat ADHD -- methamphetamines such as Adderall and the non-stimulant Strattera.

The FDA should "delay the labeling change until they have a good sense of class effect," Acting Committee Chairman Robert Nelson, of The Children's Hospital of Philadelphia, told FDA officials during the committee meeting, which was convened by the agency.

"We heard there is no terrible signal," Office of Pediatric Therapeutics Director Dianne Murphy said in the release.

"None of what I have heard today about these medications has made me particularly concerned," committee member Thomas Newman, of the University of California-San Francisco, said in the release.

The FDA was considering labeling changes to all methylphenidates with regard to psychiatric events and potential cardiovascular side effects. A review had found 36 psychiatric events for Concerta, compared to 16 for Ritalin and other methylphenidates. Concerta had 20 cardiovascular event reports, while the other methylphenidates had four such reports.

Despite the committee's advice, Murphy said the agency still may change labeling about psychiatric side effects to "try to make it clearer what the situation is with regard to certain adverse events."

Also at Thursday's meeting, federal health officials said they were following up on a small Texas study that suggested Ritalin and other stimulant drugs given to children to treat ADHD might increase the risk of cancer later in life, The New York Times reported Friday.

Scientists from the FDA, the National Institutes of Health and the Environmental Protection Agency traveled to Texas on May 23 to examine the study methods used by the researchers, from the University of Texas and the M.D. Anderson Cancer Center. The Texas researchers found damage to the chromosomes of 12 children who took Ritalin for three months, the Times reported. Drugs known to cause cancer produce similar chromosomal changes, said Dr. David Jacobson-Kram, of the FDA's Office of New Drugs.

But other experts noted that the Texas study should not cause alarm or stop doctors from prescribing Ritalin. The study was extremely small, its findings too preliminary, and it did not include a "control" group of children who had not taken Ritalin, the experts said, according to the Times.

Jacobson-Kram said additional studies were under way to try to confirm the Texas finding, but it would be at least a year before the results of those studies are known, the newspaper said.

The FDA's decision to take a closer look at the psychiatric side effects of medications for ADHD has not surprised some experts.

"These types of issues theoretically were possible with the medication because of the way it works. It's not surprising that they've had some reports that relate to psychiatric side effects..." said Dr. Lenard Adler, director of the Adult ADHD Program at New York University Medical Center. "My interpretation is that they're going to look at this, and at how often it's happening."

The drugs have been around for 40 years, she added, and have a "wide margin of safety."

"Any medicine that has therapeutic effect can have some side effects," Adler continued. "This is appropriate scrutiny by the FDA, but the benefits are also very clear and clearly outweigh the risks."

Another expert believes labeling changes may not be the answer.

"Labeling is an oversimplification of the problem," said Dr. Eugenio M. Rothe, director of the child and adolescent psychiatry clinic at Jackson Memorial Hospital and an associate professor of psychiatry at the University of Miami School of Medicine. "It scares people, and it doesn't address the other problems that are affecting the outcome. The problem is much more complex than that, and has to do primarily with the stigma associated with mental health conditions."

This is just the latest chapter in the ongoing debate over the safety of ADHD medications.

In February, Health Canada ordered Adderall XR off the market, after reports of sudden cardiac death in 20 patients.

The FDA, however, elected only to require the company to update Adderall's label to warn that it should not be used in anyone with structural cardiac abnormalities.

"The FDA is pursuing additional means to better characterize the cardiovascular risks for all drug products approved for ADHD," it said in a statement.

Other ADHD drugs would also be scrutinized for psychiatric adverse events, the statement said. That review of amphetamine products and Strattera won't be brought to the advisory committee's attention until early 2006.

The FDA stressed in its statement that it did not want to steer doctors and patients from one class of ADHD drugs with possible side effects to another class of ADHD drugs for which there is incomplete safety data.

Almost 2 million children in the United States have been diagnosed with ADHD, according to the National Institute of Mental Health.

More information

Visit the National Institute of Mental Health for more on this condition.

SOURCES: June 30, 2005, news release, FDA Advisory Committee Web site; Lenard Adler, M.D., director, Adult ADHD Program, New York University Medical Center, and associate professor, psychiatry and neurology, New York University School of Medicine, 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; July 1, 20025, The New York Times; June 29, 2005, MarketWatch; Bloomberg
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