Healthy Skepticism Library item: 3891

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Panel backs new warnings on ADHD drugs
Reuters 2006 Mar 22
http://abcnews.go.com/Health/wireStory?id=1757521

Notes:

Ralph Faggotter’s Comments:

“You have overwhelming evidence of efficacy with two rare adverse events … A black box would scare many patients away from treatment,” panel chairman Dr. Robert Nelson, the panel’s chairman.

Note: Upto 5% of children taking these drugs are affected by disturbing hallucinations.

My idea of ‘rare’ would be say 1:10,000. Dr Nelson’s idea of rare is 1:20 !!!

Full text:

Panel backs new warnings on ADHD drugs

Reuters

Mar 22, 2006 – GAITHERSBURG, Maryland (Reuters) – U.S. advisers on Wednesday called for new information about health risks on the labels of attention deficit drugs, but stopped short of recommending the strongest possible warning saying they did not want to frighten patients.

The panel of pediatric experts reviewed reports of heart problems and psychotic behavior such as hallucinations in children who took the medicines, which include Novartis AG’s Ritalin and Shire Plc’s Adderall.

Patients and parents should know about the reports even though it is unclear if the drugs contributed to the problems, panel members said. They stopped short of recommending the strong “black box” warning that a different advisory panel supported last month.

“You have overwhelming evidence of efficacy with two rare adverse events … A black box would scare many patients away from treatment,” panel chairman Dr. Robert Nelson, the panel’s chairman.

The FDA will consider both panels’ recommendations before making a final labeling decision.

Millions of children and adults take prescription drugs to treat attention deficit hyperactivity disorder, or ADHD. The condition causes trouble with focus as well as hyperactivity and impulsiveness.

Other ADHD drugs include Johnson & Johnson’s Concerta, Novartis’s Focalin, GlaxoSmithKline Plc’s Dexedrine and Eli Lilly and Co.‘s Strattera.

Copyright 2006 Reuters News Service. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.