Heartburn drug investigated over cancer fears

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Tista' taqra bil- Malti.

The European Medicines Authority is investigating a heartburn medicine following concerns that it may contain the presence of impurities.

A spokesperson for the Medicines Authority told Newsbook.com.mt that the sale of this medicine on the Maltese market is authorised. The European Medicines Agency is investigating the medicine over the presence of impurities in Zantac and other ranitidine products.

A recall by the Market Authorisation Holder was made of the product. The spokesperson urged those making use of the medicine to speak to their doctor or pharmacist if they have any concerns.

Recalls of the medicine have already been announced in Canada and France, while America and European authorities are investigating.

On 13 September both the US Food and Drug Administration (FDA) and the EMA published their decision to review the presence of N-nitrosodimethylamine (NDMA) in medicines containing the drug ranitidine.

NDMA has been classified as a substance which could cause cancer based on animal studies.

The European Medicines Authority said that NDMA is found in water and foods including meats, dairy products and vegetables, but is not expecting to cause harm when ingested in very low levels.

The products are used to reduce the production of stomach acid in patients with conditions such as heartburn and stomach ulcers.