GSK recalls popular heartburn drug Zantac globally after cancer scare

Henrietta Strickland
October 9, 2019

GlaxoSmithKline Plc is recalling its heartburn medicineZantac as a "precautionary measure" due to a probable cancer-causing impurity in the drug, Britain's medicines watchdog said on Tuesday.

Pharmacists are being advised to stop supplying some ranitidine (Zantac; GSK) products after it was revealed that they may be contaminated with the impurity N-nitrosodimethylamine (NDMA).

Community pharmacy teams are asked to quarantine all remaining stocks of these four batches of Zantac products and return it through the suppliers' approved process.

But patients should keep taking their prescribed medicine, officials advise.

Anyone who is concerned about taking their medication should speak to their doctor or pharmacist.

It asked manufacturers to quarantine all ranitidine products which may contain the active pharmaceutical ingredient potentially affected by the issue.

Over-the-counter products that also bear the Zantac name are made by a different company and are unaffected, the MHRA said.

Dr Andrew Gray, from the MHRA, said: "Whilst this action is precautionary, the MHRA takes patient safety very seriously".

He added: "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 the world".

"We have also requested risk assessments from the relevant companies which will include the testing of potentially affected batches". NDMA is one of the potential carcinogens the FDA previous year learned could also be formed during the manufacturing of certain sartan high blood pressure meds that led to a global recall.

It's found in water and foods such as meats, dairy products and vegetables.

GSK, the original developer of the antacid Zantac, in an emailed comment today pointed out that it does not sell Zantac prescription or over-the-counter products in the U.S. Sanofi has U.S. rights to the brand.

Other reports by Click Lancashire

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