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28 Nov

By pharmatrax

Category: News

Tesco, Sainsbury’s and ASDA recall own-brand versions of the heartburn and indigestion drug Zantac over fears they are contaminated with a cancer-causing chemical No Comments

Tesco, Sainsbury’s and ASDA recall own-brand versions of the heartburn and indigestion drug Zantac over fears they are contaminated with a cancer-causing chemical

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  • The supermarket products were among 13 new additions to an ongoing recall
  • Products in the UK and US have been taken off shelves due to contamination
  • Ranitidine drugs are thought to have traces of NDMA, which is linked to cancer 

Heartburn and indigestion tablets have been recalled from major UK supermarkets over concerns they contain a chemical linked to cancer.

Tesco, Asda and Sainsbury’s own-brand ranitidine drugs have been pulled from the shelves in the latest development in an ongoing global contamination scandal.

An announcement from the Medicines and Healthcare products Regulatory Agency (MHRA) today revealed another 13 non-prescription products have been affected.

It comes after a string of recalls of ranitidine, including Zantac, following the discovery of N-nitrosodimethylamine (NDMA) contamination.

NDMA is ‘probably carcinogenic’, according to the World Health Organization, and can disrupt enzymes in the liver and damage DNA.

Recalls first began after tests in the US discovered traces of NDMA in some branded Zantac products in June.

The US Food and Drug Administration launched an investigation and, since, makers of drugs containing ranitidine have been regularly announcing recalls around the world.

The pharmacy which first discovered the impurity said it was an ‘inherent instability’ and could affect all drugs containing ranitidine.

So far, regulators in the US, UK, Italy, France, and Ireland have all announced recalls, while some pharmaceutical companies have withdrawn products around the world.

Today’s announcement involves four companies deciding to take their ranitidine products off shelves in the UK – OTC Concepts, Relconchem, Noumed Life Sciences, and Medreich.

Medich is recalling specific batches from retailers but the other three are advising companies not to sell any of their ranitidine products listed in the recall.

Dr. Andrew Gray, MHRA’s 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.

Asda's own-brand ranitidine indigestion and heartburn relief, which is manufactured by Medreich PLC, is in the recallSainsbury's own-brand indigestion relief is also distributed by Medreich and has been withdrawn

Both Asda and Sainsbury’s have withdrawn their ranitidine indigestion and heartburn relief remedies as a result of an ongoing global contamination scandal

‘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 the world.’

Other manufacturers which took their products off sale include Novartis, Saraca Laboratories, GlaxoSmithKline, Apotex, and Teva UK.

HOW THE ZANTAC RECALLS HAVE UNFOLDED

JUNE – Online pharmacy Valisure detects NDMA in some batches of Zantac and tells the US Food and Drug Administration (FDA)

SEPTEMBER 13 – The FDA confirms some batches of ranitidine pills, including Zantac, contain trace amounts of NDMA and launch an investigation

Valisure asks the FDA to recall all products containing ranitidine. It says the impurity was the result of the ‘inherent instability’ of the ranitidine molecule, claiming every ranitidine-based drug could be affected

SEPTEMBER 18 – Pharmaceutical giant Novartis’s subsidiary firm Sandoz stops distributing its prescription form of ranitidine worldwide

SEPTEMBER 20 – Italian health chiefs recall more than 500 drugs containing ranitidine made by Indian manufacturer Saraca Laboratories because of the NDMA impurity fears

SEPTEMBER 23 – The Irish equivalent to the MHRA – the Health Products Regulatory Authority – recalls 13 medications containing ranitidine, including seven versions of Zantac. It says the fault comes from the manufacturing plant of the chemical in India. Sandoz recalls its generic version of ranitidine in the US

SEPTEMBER 24 & 25 – GlaxoSmithKline recalls four different types of Zantac in Hong Kong. The next day, it pulls the drug in India, where it is branded as Zinetac. It also halts global distribution of popular medicine

French health officials recall all branded and generic versions of ranitidine. Canadian chiefs reveal Apotex Inc, Pro Doc Limitée, Sanis Health Inc and Siem Pharmaceuticals ULC are all recalling their ranitidine drugs

SEPTEMBER 28 – US retailer CVS removes Zantac and its own generic ranitidine products from 6,200 of its stores over NDMA fears

OCTOBER 1 – Walgreens and Rite Aid announce they are both pausing sales of Zantac and ranitidine over the same fears

OCTOBER 2 – GlaxoSmithKline voluntarily recalls its other two types of ranitidine tablets in Ireland

OCTOBER 8 – GSK recalls four prescription-only types of Zantac in the UK

OCTOBER 17 –  Teva UK issued a nationwide recall for batches of two types of ranitidine

NOVEMBER 19 – UK firms Creo Pharma and Tillomed Laboratories recall their 150mg ranitidine tablets and 30mg/ml oral solution, respectively

NOVEMBER 21 – UK companies OTC Concepts, Relconchem, Noumed Life Sciences, and Medreich recall their non-prescription ranitidine heartburn and indigestion relief tablets. These include own-brand remedies sold by three of the UK’s biggest supermarkets, Tesco, Sainsbury’s and Asda.

Source : https://www.dailymail.co.uk/health/article-7710693/Sainsburys-Tesco-ASDA-recall-heartburn-indigestion-drugs-contamination-fears.html

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