The South African Health Products Regulatory Authority (SAHPRA) has learned about the safety concerns regarding the presence of a nitrosamine impurity called NDMA in ranitidine-containing medicines. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on the results of animal studies. NDMA is a known environmental carcinogen and it is present in some foods and in water supplies in small quantities. NDMA is not expected to cause any harm when very small quantities are ingested.

Ranitidine is used to treat the production of stomach acid in patients with conditions such as heartburn and stomach ulcers. It is available as an over-the-counter (OTC) and prescription medicine. OTC ranitidine has been approved by SAHPRA to prevent and treat symptoms of heartburn due to acid indigestion and excess stomach acid, while prescription ranitidine has been approved for treatment and prevention of various indications such as ulcers (stomach and intestinal) and gastroesophageal reflux disease.

SAHPRA has issued a media release and the subsequent media articles and interviews have been informative to the public. SAHPRA also issued “Dear Healthcare Professional” letters, informing pharmacies about this safety concern. Some Ranitidine-containing products have been removed from the market or temporarily recalled while investigations are being undertaken. The following actions were taken by manufacturers:

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