2005P-0402
FDA Comment Number : EC1
Submitter : Mr. Dave Lowe Date & Time: 12/09/2005 11:12:12
Organization : Mr. Dave Lowe
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
This calls for a label change on all lithium containing drugs which would add an indication, and while a laudible goal is included, more approriately done in a placebo controlled clinical trial.

The petition includes Eskalith and other drugs as currently marketed products such as Eskalith (NDA # 017971) which is discontinued drug and should be removed from the market immediately.

This use well referenced meta-analytical reviews dating from 1970 through 2005. However it includes open, uncontrolled, and nonrandomized studies to support an across the board label change, which are generally not acceptable for use in FDA regulated advertising claims.

I oppose attempts to add any indications to any class of drugs through the Federal Register, in what would normally be done in FDA reviewed, placebo controlled clinical trials. I urge immediate action on withdrawing Eskalith and other unapproved lithium based products from the market.