Abstract

THE RANITIDINE CONTROVERSY (FROM BLOCKBUSTER TO BAN)

Purva P. Wankhede*, Assit. Prof. Farheen A. Shah and Dr. Rahul S. Bijwar

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Abstract

Ranitidine, a commonly used medication for managing heartburn, acid reflux, and ulcers, became the focus of a global health debate in 2019. Sold under various brand names, including Zantac, the drug was discovered to contain or generate Nnitrosodimethylamine (NDMA), a substance classified as a probable human carcinogen, under certain conditions or during storage. Investigations revealed that NDMA levels could increase over time or when exposed to heat, raising serious concerns about its long-term safety. Regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) responded by issuing warnings, initiating recalls, and eventually banning ranitidine in several countries. This controversy brought attention to issues surrounding manufacturing standards, testing protocols, and the regulation of pharmaceutical impurities. It highlighted the critical importance of stringent drug safety monitoring, the complexities of addressing public health risks, and the broader implications for patient confidence and healthcare systems. The ranitidine case underscores the necessity of transparent scientific investigation and proactive measures to safeguard the safety and effectiveness of medications.

Keywords: Ranitidine, Peptic Ulcer, NDMA, Cancer Risk, Histamine.