The FDA released a report in July of a trial on children and adolescents of the selegiline (Emsam) transdermal patch for treatment of depression, but few pharmacists and doctors know about it because it was not published, according to Patient Drug News. The FDA report declared that “the benefits of Emsam in this population have not been adequately demonstrated.” Patient Drug News has provided an analysis and commentary about the report.
Selegiline is a monoamine oxidase inhibitor and, according to Patient Drug News, even in adults the drug only decreased patient scores on the HAM-D depression rating scale by about 2.5 points out of nearly 30. “It is not known if small changes in HAM-D rating scale scores produce a benefit that is important to patients or their family members,” commented Patient Drug News.
The FDA specifically recommended avoiding use of the selegiline Emsam patch in children because of the risk of hypertensive crisis. Patient Drug News also discussed a number of other risks of the drug, including suicidal thoughts, and possible dangerous interactions with other common drugs, foods and remedies.
Avoid Using! Selegiline Patches for Depression in Children and Adolescents – No Evidence It Works (Patient Drug News, October 17, 2014)
Clinical Review – Selegiline Transdermal System (US Food and Drug Administration. July 8, 2013.)
Again: the drug has close to zero clinical efficacy in adults, has never been proved to help kids at all and it will still be prescribed and given to unsuspecting patients “off label” with massive harmful effects which will go unreported and unmitigated for decades with thousands of victims.
In other words a typical psychiatric success story.
How is it even legal to market this thing? The FDA can de-license it at any time. Caveat emptor, I guess…