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By pharmatrax
Category: News
No CommentsHeartburn 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in the US, UK, Italy, France, and Ireland have all announced recalls, while some pharmaceutical companies have withdrawn products around the world.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.
Both Asda and Sainsbury’s have withdrawn their ranitidine indigestion and heartburn relief remedies as a result of an ongoing global contamination scandal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.