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Ranitidine is currently in very short supply both in the UK and around the world. Major manufacturers have undertaken a product recall, and new stock is not being released to the market. Despite the sudden shortage of ranitidine occurring from mid-October, shortly before the previous Brexit deadline, this situation is not related to the UK’s relationship with the EU. Rather, this situation has arisen because of concerns over potentially carcinogenic impurities within the medication and affects most brands from most manufacturers.
The issues began after a review by the European Medicines Agency (EMA) identified that some ranitidine brands were found to contain low levels of the nitrosamine impurity called N-nitrosodimethylamine (NDMA). NDMA is classified as a probable human carcinogen by the International Agency for Research on Cancer, the specialised cancer agency of WHO. However, it is also accepted that NDMA can be an environmental contaminant found in water supplies and food (dairy products, meat and vegetables). A similar situation arose in 2018, with investigations into NDMA and other nitrosamine impurities’ potential presence in angiotensin II receptor blockers (ARBs). This also resulted in the recommendation for numerous recalls due to unacceptable levels of nitrosamines, but was not a significant issue in paediatric practice due to the low level of use of ARBs. With regards to ranitidine, neither the EMA nor the Medicines and Healthcare Products Regulatory Agency have indicated that there is a current risk to patients although we are aware …
Contributors DH conceived the editorial. MER, CB and DH wrote and edited the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests CB and DH are the Chair and Vice Chair, respectively, of the RCPCH medicines committee.
Patient consent for publication Not required.
Provenance and peer review Commissioned; internally peer reviewed.