Summary

Original source:
http://money.cnn.com/2005/07/01/news/fortune500/fda_panel.dj/

Details

• 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.
• 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."
• Some of the patients reported hallucinations, suicidal thoughts and suicide attempts.
• 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.
• 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.

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