FDA Panel Wants Warnings On ADHD Medications

http://pn.psychiatryonline.org/cgi/content/short/41/5/1

March 3 2006
Government News

FDA Panel Wants Warnings On ADHD Medications

Excerpts:

An unexpected recommendation to add a black-box warning to the labels of all
stimulant medications used for ADHD proves to FDA staffers that you can
never predict what an advisory committee will do.

"I want to cause people's hands to tremble a little bit before they write
that prescription" for an ADHD medication, said Cleveland Clinic
cardiologist Steven Nissen, M.D., a consultant to the advisory committee.
Indeed, it was Nissen who suggested the committee consider endorsing a
black-box warning because he saw a need "to slow the growth of utilization."

Gelperin said those 39 reports were a subset of the 81 MedWatch reports of
deaths in patients taking at least one stimulant medication. However, she
said, most of the reports involved multiple medications and other possible
causes of deaths and so were discounted. Gelperin also warned that the 39
death reports in her analysis were not definitively tied to an ADHD
medication, but "are simply associated." The FDA received an additional 54
reports of serious, nonfatal, cardiovascular events, Gelperin added,
including reports of heart attacks and strokes in both children and adults
between 1999 and 2003.

The FDA's briefing materials from the February 9 meeting of the Drug Safety
and Risk Management Advisory Committee are posted at
http://www.fda.gov/ohrms/dockets/ac/...202_00_TOC.htm