The Drugs Containing Ranitidine Will Be Withdrawn from Bulgarian Market

The sale of medicines containing ranitidine will be stopped in Bulgaria. This was reported by the Bulgarian Drug Agency (BDA). The blocking is a preventative measure for the review by the European Medicines Agency (EMA) of medicinal products containing ranitidine for suspected potential contamination with N-nitrosodimethylamine (NDMA), a probable human carcinogen, in the active substances from which they are manufactured. The doubt stems from data provided to private laboratories outside the EU.

Although the EMA has explicitly emphasized that there is no recommendation to discontinue the use of ranitidine-containing medicinal products, most EU and third countries are taking action to suspend sales of these medicinal products as a precautionary measure, the BDA said.

Ranitidine is an active substance used to reduce gastric acid production in patients with gastric ulcer or gastroesophageal reflux, and NDMA is classified as a probable human carcinogen based on animal studies. It is present in some foods and in some sources of water, but is not expected to cause harm by ingestion in small quantities.

However, patients should not discontinue ranitidine treatment without consulting their physician, as the risk of discontinuation of the drug is significantly greater than the risk of continued administration until further consultation with the physician. There are other drugs on the market with other active ingredients that have the same therapeutic indications, the BDA recalled.

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