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Association between ranitidine use with potential NDMA impurities and risk of cancer in Korea

Kyung-In Joung1,2,3, Jung Eun Hwang2, In-Sun Oh2,4,5

  • 1School of AI Healthcare, College of Integrated Health Sciences, Cha University, Pocheon, Republic of Korea.

Scientific Reports
|December 27, 2022
PubMed

Insights

Ranitidine use, despite N-Nitrosodimethylamine (NDMA) concerns, showed no increased cancer risk in a South Korean study. Further research is needed due to the follow-up period limitations.

Area of Science:

  • Pharmacovigilance and Drug Safety
  • Epidemiology and Public Health
  • Gastroenterology and Oncology

Background:

  • N-Nitrosodimethylamine (NDMA) contamination in ranitidine products has raised global health concerns.
  • Regulatory agencies worldwide have investigated and recalled ranitidine due to unacceptable NDMA levels.

Purpose of the Study:

  • To investigate the association between ranitidine use and the risk of developing cancer.
  • To evaluate overall cancer incidence and specific major cancer risks in ranitidine users compared to other histamine-2 receptor antagonists (H2RAs).

Main Methods:

  • A cohort study utilized South Korean National Health Insurance Service-National Sample Cohort data from 2002-2015.
  • Patients aged 40+ initiated on ranitidine or other H2RAs, with a 2-year washout period, were included. Propensity score matching was applied.
  • Cancer risk was assessed using Cox regression, with a lag time of up to 6 years.

Main Results:

  • A total of 25,360 patients were analyzed after matching.
  • Ranitidine use was not significantly associated with an increased risk of overall cancer (aHR 0.98, 95% CI 0.81-1.20).
  • No increased risk was observed for major individual cancers, and higher cumulative ranitidine exposure did not elevate cancer risk.

Conclusions:

  • This study suggests no significant association between ranitidine use and increased cancer risk.
  • Findings should be interpreted cautiously due to the limited follow-up duration.
  • Further long-term studies are warranted to definitively assess the cancer risk associated with ranitidine exposure.

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