Prescribed heartburn medicine Zantac recalled in UK over fears it may contain cancer-causing chemical

Katy Clifton8 October 2019

A popular type of heartburn medicine is being recalled in the UK as a "precautionary measure" due to concerns the product may contain a cancer-causing chemical.

GlaxoSmithKline issued a recall on Tuesday of four types of the heartburn drug Zantac which are only available on prescription.

The move follows the discovery by the US Food and Drug Administration last week of "unacceptable levels" of a cancer-causing impurity in Zantac and its generic versions known chemically as ranitidine.

The four types of drug being recalled in the UK are Zantac 150mg/10ml Syrup, Zantac 50mg/2ml Injection, Zantac 150mg Tablets and Zantac 300mg Tablets.

However, patients should keep taking their prescribed medication, officials advised.

A spokesman for the Medicines and Healthcare products Regulatory Agency (MHRA) said the health risk of discontinuing the medication is higher than the potential risk of the impurity N-nitrosodimethylamine (NDMA).

Over-the-counter Zantac products are made by a different pharmaceutical firm and are not being recalled.

Healthcare professionals have been told to stop supplying the four prescription products immediately, quarantine all remaining stock and return it to their supplier.

The contaminant is classified as a probable human carcinogen but is not expected to cause harm when ingested in very low levels.

A spokesman for the MHRA said anyone concerned about taking their prescription should speak to a doctor or pharmacist.

Dr Andrew Gray, MHRA Deputy Director of Inspections, Enforcement & Standards, said: “Whilst this action is precautionary, the MHRA takes patient safety very seriously.

“Patients should keep taking their current medicines but should speak to their doctor or pharmacist if they are concerned and should seek their doctor’s advice before stopping any prescribed medicines.

“We have asked companies to quarantine batches of potentially affected medicines whilst we investigate and we will take action as necessary, including product recalls where appropriate.

“We have also requested risk assessments from the relevant companies which will include the testing of potentially affected batches.

“Currently, there is no evidence that medicines containing nitrosamines have caused any harm to patients, but the Agency is closely monitoring the situation, and working with other Regulatory Agencies around world.”

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