Colchicine: A Comprehensive Clinical and Pharmacological Review

I. Introduction to Colchicine

A. Overview and Historical Context

Colchicine is an alkaloid medication with a long-standing history in therapeutics, primarily recognized for its utility in treating inflammatory conditions such as gout and Familial Mediterranean Fever (FMF). More recently, its therapeutic scope has expanded to include the prevention of major cardiovascular events.[1] The historical significance of colchicine is profound; it represents one of the oldest known remedies still in contemporary medical use. Its origins as an herbal treatment for joint pain can be traced back to ancient Egyptian medical texts, such as the Ebers Papyrus, dating to approximately 1500 BCE. The active alkaloid, colchicine itself, was subsequently isolated from its plant source in the early 19th century.[2]

The journey of colchicine from an ancient herbal remedy to a regulated pharmaceutical agent is noteworthy. Despite its millennia of use, formal approval by regulatory bodies like the U.S. Food and Drug Administration (FDA) occurred relatively late in its history. This delay is partly attributable to initiatives such as the FDA's Unapproved Drug Initiative (UDI), which aimed to bring historically unapproved but widely utilized medications under rigorous regulatory oversight. The first FDA-regulated colchicine product, Colcrys, entered the market in 2009.[2] This regulatory pathway had substantial implications for the market availability and pricing of colchicine, aspects that will be explored further in this report. The evolving understanding of colchicine's therapeutic actions is also evident in its expanding indications. Initially valued for its anti-inflammatory effects in crystal-induced arthropathies and autoinflammatory syndromes, its role in cardiovascular protection underscores a deeper appreciation of its pleiotropic effects and the pivotal role of inflammation in a wider spectrum of d