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Two more UK pharmaceutical companies are recalling their versions of Zantac over fears they are contaminated with a cancer-causing chemical.
Ranitidine, the generic name of the branded heartburn drug, has been the subject of global drug recalls since September.
Traces of a chemical linked to cancer – N-nitrosodimethylamine – have been found in supplies of the medicine.
Pharmacies have now been warned not to dispense ranitidine products produced by Creo Pharma and Tillomed Laboratories.
This is the fourth ranitidine warning made by the Medicines and Healthcare products Regulatory Agency (MHRA). The watchdog issued three others in October.
Creo Pharma is recalling its 30mg/ml ranitidine oral solution, making it the latest of a string of companies to stop selling their products containing the heartburn drug
‘Whilst this action is precautionary, the MHRA takes patient safety very seriously,’ said deputy director of enforcement, Dr. Andrew Gray.
‘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.’
He added: ‘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 MHRA is closely monitoring the situation, and working with other regulatory agencies around the world.’
Creo Pharma is recalling its 30mg/ml ranitidine oral solution, and Tillomed its 150mg ranitidine tablets. Both are only available on prescription.
The MHRA told healthcare professionals to stop giving out the ranitidine products, quarantine them and returned to their suppliers.
The recall adds to one by GlaxoSmithKline, which makes drugs with the brand-name Zantac.
Teva UK, Rosemont Pharmaceuticals, and the firm that produces own-brand versions for Boots and Morrisons all also had to stop selling their versions.
N-nitrosodimethylamine (NDMA) can develop in the water when certain chemicals, such as pesticides, chlorine, and ammonia or fuels break down.
It is deemed ‘probably carcinogenic’ by the World Health Organization’s International Agency for Research on Cancer.
This means it may contribute to cancer and the WHO suggests the chemical can do so by disrupting enzymes in the liver and damaging DNA.
Zantac and generic forms of ranitidine have also been recalled in the US.
Concerns that ranitidine contained traces of NDMA first emerged in June when US-based pharmacy Valisure first discovered it in some of its Zantac products.
The FDA issued a warning about the impurity on September 13 and launched an investigation alongside European officials to determine the risk to patients.
It is unclear how long the fault dates back to – but some blood pressure pills recalled earlier this year due to a similar impurity had already been on the market for two years.
Valisure’s initial research found that NDMA was the result of the ‘inherent instability’ of the ranitidine molecule.
It claims that all versions of the drug are affected and could generate very high levels of NDMA in the human body.
But health officials in various countries instead suspect the fault comes from the manufacturing plant of the chemical in India.
NHS figures show almost six million prescriptions were dished out for ranitidine in England last year.
Zantac is not the first medication to be recalled in the UK over fears it could contain NDMA.
The MHRA has pulled a series of heart drugs in the last year after tests revealed some batches contained NDMA or a similar chemical.