Why The US FDA Requested Ranitidine Withdrawal; How Other Withdrawals Could Follow

Agency worried what might happen beyond expiry or room temperature to generate carcinogenic impurities in ranitidine; will guide assessment of nitrosamine risks in other drugs.

Molecule of ranitidine,
Ranitidine withdrawal driven by storage-related nitrosamine risks • Source: Shutterstock

Concerns about nitrosamine impurities led the US Food and Drug Administration on 1 April to request immediate withdrawal of all prescription and over-the-counter ranitidine drugs, commonly known as Zantac, from the US market, and to ask pharmaceutical companies to check for similar risks in their other drug products.

The agency plans to provide guidance soon on how it expects manufacturers to assess the risk of nitrosamine formation in all their drug products. EU regulators imposed a similar requirement...

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