Abstract

THE HIDDEN DANGER IN ACID-REDUCING DRUGS: RANITIDINE AND THE NDMA CRISIS

Thirumalai R.*, Pravinkumar S., Yazhini B., Dhatchanamoorthi K.

.

Abstract

Ranitidine, a widely used histamine H₂-receptor antagonist, has been a mainstay treatment for acid-related gastrointestinal disorders since its introduction in the 1980s. However, recent discoveries of NNitrosodimethylamine (NDMA), a probable human carcinogen, in Ranitidine products have raised significant safety concerns. NDMA formation occurs due to the inherent chemical structure of Ranitidine and is exacerbated by factors such as heat, humidity, and acidic conditions, leading to potential carcinogenic risks through DNA damage mechanisms. This prompted global regulatory agencies, including the USFDA, EMA, and CDSCO, to issue recalls and suspensions of Ranitidine, highlighting gaps in post-marketing drug surveillance and the need for continuous stability evaluation. The public and clinical response involved widespread patient panic, disruption of prescribing practices, and legal challenges. Safer alternatives like Famotidine and Proton Pump Inhibitors (PPIs) have since become preferred options due to their chemical stability and favorable safety profiles. This review discusses the mechanism of NDMA formation, carcinogenic implications, regulatory actions, and clinical impact, emphasizing the necessity for rigorous drug safety monitoring and the prioritization of nitrosamine-free therapies in acid suppression.

Keywords: Ranitidine, N-Nitrosodimethylamine, Carcinogenicity, Nitrosamine contamination, Drug recall, Drug safety monitoring, Regulatory actions, Pharmaceutical stability.