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FDA Gets Tough on ADHD Drugs

New labels that highlight psychiatric side effects will be ordered for one class of medicines

WEDNESDAY, June 29, 2005 (HealthDay News) -- Citing concerns about possible psychiatric side effects, the FDA said it will add new label warnings to a class of drugs used to treat attention-deficit hyperactivity disorder (ADHD).

These medications, called methylphenidates, include the widely prescribed Concerta. Two other types of drugs, methamphetamines, which include Adderall, and the non-stimulant atomoxetine (Strattera), are also used to treat ADHD. Almost 2 million children in the United States have been diagnosed with the disorder, according to the National Institute of Mental Health.

"Post-marketing reports received by FDA regarding Concerta and other methylphenidate products include psychiatric events such as visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior," the agency explained in documents posted on its Web site.

The Associated Press reported Wednesday that the FDA found 36 cases of psychiatric side effects among children using Concerta.

"We intend to make labeling changes describing these events," the FDA said in its documents.

The agency's pediatric advisory committee is to meet Thursday to discuss the proposed labeling changes.

The move did not come as a surprise to 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, Adler 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 medications for ADHD.

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. At the time, the agency told HealthDay that it was satisfied with the safety profile of the medication.

While labeling changes to include information on psychiatric side effects seemed a certainty, the FDA appeared less sure about cardiovascular side effects.

"It is not yet possible to determine whether these events, especially the more serious ones, are causally associated with these treatments," the statement read.

And officials indicated they did not plan to limit their attention to methylphenidates.

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

They said other ADHD drugs would also be scrutinized for psychiatric adverse events: "We believe it is critical to examine the other stimulant drug products approved for ADHD, specifically the amphetamine products, and atomoxetine (Strattera), to determine if they, too, are associated with these adverse events," the statement read.

The review of amphetamine products and atomoxetine wouldn't be brought to the advisory committee's attention until early 2006.

The agency 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.

More information

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

SOURCES: 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 of psychiatry, University of Miami School of Medicine; June 29, 2004, MarketWatch; Bloomberg; FDA statement
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