Risk of Cancer in Association with Ranitidine and Nizatidine vs Other H2 Blockers: Analysis of the Japan Medical Data Ce
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ORIGINAL RESEARCH ARTICLE
Risk of Cancer in Association with Ranitidine and Nizatidine vs Other H2 Blockers: Analysis of the Japan Medical Data Center Claims Database 2005–2018 Masao Iwagami1,2 · Ryosuke Kumazawa3 · Yoshihisa Miyamoto4 · Yuri Ito5 · Miho Ishimaru1 · Kojiro Morita1 · Shota Hamada6 · Nanako Tamiya1 · Hideo Yasunaga2 Accepted: 13 November 2020 © Springer Nature Switzerland AG 2020
Abstract Introduction In September 2019, ranitidine and nizatidine were suggested to contain N-nitrosodimethylamine, a carcinogenic substance. People have since been concerned about the potential impact of ranitidine/nizatidine use on the risk of cancer. Objective The objective of this study was to investigate the risk of cancer among people receiving ranitidine or nizatidine compared with other histamine 2 receptor antagonists (H2 blockers) [cimetidine, famotidine, roxatidine, and lafutidine]. Methods In the Japan Medical Data Center claims database (comprising people aged 730 DDDs. Conclusions We found no evidence that ranitidine/nizatidine is associated with an increased risk of cancer, although further studies with more accurate measurement of exposure, inclusion of older people, and longer follow-up may be needed.
1 Introduction Histamine 2 receptor antagonists (H2 blockers) have been used to treat peptic ulcers, gastritis, and reflux esophagitis. In September 2019, the European Medicines Agency and US Food and Drug Administration announced that ranitidine hydrochloride contains N-nitrosodimethylamine (NDMA) Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40264-020-01024-0) contains supplementary material, which is available to authorized users. * Masao Iwagami iwagami‑[email protected] Extended author information available on the last page of the article
[1–3], which is “probably carcinogenic to humans (group 2A)” according to the International Agency for Research on Cancer [4]. The Japanese Ministry of Health, Labour and Welfare responded to this statement by asking domestic suppliers to analyze their products [5], and NDMA was indeed detected in ranitidine as well as in nizatidine, the chemical formula of which is similar to that of ranitidine [6]. Consequently, all ranitidine products (including tablets and injectable formulations) were recalled from the market in Japan [7], as in the USA and Europe [8–12]. Sensational reporting of these incidents by the media has since raised concern about the risk of cancer in association with previous ranitidine/nizatidine use [13]. Thus, from a public health perspective, it is important to promptly investigate the risk of cancer associated with ranitidine and
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Key Points In the Japan Medical Data Center claims database (comprising employed workers in medium- to largescale companies and their family members aged
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