Abstract

REBIRTH OF THALIDOMIDE

Vishruti Mhatre*, Lokesh Kumar Vyas and Dr. Dileep Kumar Bharati

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Abstract

Thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women. It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of newborn children if it was taken between 34th and 50th day of pregnancy, counting from the first day of the last menstrual cycle. The drug was banned from the market after causing catastrophic collapse. The drug was brought back in for the treatment of multiple myeloma and leprosy. Research on thalidomide mechanisms of action is leading to a better understanding of molecular targets. With an improved understanding of these molecular targets, safer drugs may be designed. The thalidomide tragedy marked a turning point in toxicity testing, as it prompted United States and international regulatory agencies to develop systemic toxicity testing protocols; the use of thalidomide as a tool in developmental biology led to important discoveries in the biochemical pathways of limb development. The US FDA ran through several clinical trials before reintroducing the drug into the market. Further, the tragedies associated with this agent stimulated the legislation which revamped the FDA regulatory process, expanded patient informed consent procedures and mandated more transparency from drug manufacturers.

Keywords: Multiple Myeloma, Leprosy, Molecular Targets, Toxicity, Biochemical, Testing Protocols.