It has been more than 35 years since clozapine was approved by the FDA for use in the United States. Since then, there have been major advances in pharmacokinetics as well as a substantial accumulation of real-world evidence about its use. In two articles in the May-June 2025 issue of the Journal of Clinical Psychopharmacology, Dr. Jose de Leon and dozens of colleagues call on the FDA to make important changes to the drug’s product label to reflect current knowledge about the drug’s pharmacology, safety profile, and proper titration. The stakes are high: The medication can be used effectively for treatment-resistant schizophrenia, but there has been concern that it has been underused, resulting in poorer outcomes for patients, including a high rate of suicides. Updating the package insert would help to educate clinicians on its proper use and monitoring for adverse effects.

In this podcast, Dr. Julia Ann Koretski, JCP’s digital editor, leads a panel discussion on the articles by Dr. de Leon and colleagues. In addition to Dr. de Leon, the other panelists include Dr. Larry Alphs, author of an editorial about the topic, Dr. Richard Balon, a coauthor and JCP Associate Editor, and Dr. Anthony Rothschild, a coauthor and Editor-in-Chief of the journal.

 

Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts Worldwide. Part I

 

Letter to the FDA Proposing Major Changes in the US Clozapine Package Insert Supported by Clozapine Experts.  Part II

 

Incorporating Real -World Treatment Data Into Clozapine's Product Label