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FDA panel wants clearer ADHD labels
Agency asked to proceed with plans for warnings about hallucinations, suicide risk.
July 1, 2005: 7:21 AM EDT

WASHINGTON -(Dow Jones)- A Food and Drug Administration panel said Thursday the agency should move forward with plans to rewrite labels for Concerta, Ritalin and other drugs widely used to treat attention deficit hyperactivity disorder to more clearly warn of the possibility of hallucinations and suicidal tendencies in patients taking the drugs.

While such reports of serious psychiatric problems are rare and there is no proof they were caused by the drugs, the FDA said a fuller discussion of the reports should be on drug labels. Current labeling discusses psychiatric problems that could be associated the drugs, but agency officials said they believe the labels don't clearly spell out the frequency and types of specific psychiatric problems. The FDA made its decision to rewrite labels after reviewing 135 adverse event reports from Dec. 4, 2003, to Jan. 4, 2005 , involving Johnson & Johnson's (JNJ) Concerta, a long-acting form of methylphenidate, the generic name for Ritalin, made by Novartis AG . (NVS).

The Concerta review was mandated by law in drugs that are studied for use in children. Almost eight million prescriptions were written for Concerta during the same time period covered by the FDA review.

"The agency is struggling," said Dianne Murphy, director of the FDA's office of pediatric therapeutics. "We have a concern, but we may not be able to articulate it with certainty." Murphy and other FDA officials said they are only rewriting labels and aren't thinking about placing a stricter "black box" warning on ADHD drugs.

The FDA brought the review of Concerta to its pediatric advisory panel for advice on how best to communicate its concerns to the public. The agency didn't focus on another category of ADHD drugs that includes Shire Pharmaceuticals PLC's (SHPGY) Adderall, which was ordered off the market earlier this year in Canada after reports of 20 sudden deaths in patients, including 12 strokes.

The FDA is already reviewing ADHD drugs for links to more serious problems like stroke. The drug labels already warn of increased blood pressure and suggest the drugs can make any underlying psychiatric disorders worse. New labeling changes won't take place until the cardiovascular and psychiatric reviews are complete early next year.

Patrick Ciccone, vice president of medical affairs for the J & J unit that makes Concerta, said the company is reviewing the adverse-event reports with the FDA and would "do what's in the best interest of patients."

Of the 135 adverse event reports involving Concerta, the FDA was mainly concerned with 36 psychiatric events in young people. Of those, six patients have a previous history of psychiatric illnesses. Some of the patients reported hallucinations, suicidal thoughts and suicide attempts.

Susan McCune, the FDA medical officer who reviewed the adverse reports for Concerta, noted that, of 11 reports of suicidal thoughts or attempts, six patients improved once they stopped taking Concerta. However, she and other FDA officials said it was impossible to tell whether Concerta caused the problem or if patients would have developed the problem anyway.

Several panel members, including Robert M. Nelson, a critical care specialist at Children's Hospital in Philadelphia, said stimulants - which are a broad category into which most ADHD drugs fall - could bring out a previously unknown psychiatric disorder that would have likely developed anyway at a later time.

Larry Greenhill, a New York psychiatrist who spoke on behalf of American Academy of Child and Adolescent Psychiatry, said his group supported putting clearer labels on ADHD drugs. He also said reports of serious psychological problems among ADHD patients is probably about 1 in 5,000.

Paul Andreason, the team leader in the FDA's division of neuropharmacological drug products and a psychiatrist, told the panel that stimulants have been shown to cause psychiatric problems in high doses. However, he said, ADHD drugs are safe and effective at approved doses and noted that his 18-year-old daughter has taken a stimulant ADHD drug for 10 years. In fact, he says, he now feels guilty for waiting for five years before starting the medication because he said the drug has helped her concentration enormously.

ADHD is a disorder in which people have difficulty concentrating or staying on a task to the extent that it causes impairment in academic, work or social settings. People with ADHD are often hyperactive and impulsive.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; .

(END) Dow Jones Newswires

06-30-05 1705ET Copyright (c) 2005 Dow Jones & Company, Inc. Copyright (C) 2005 Dow Jones & Company, Inc. All Rights Reserved.  Top of page


Food and Drug Administration (FDA)
Product Labeling
ADHD Disorders
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