Two more UK companies recall their versions of Zantac heartburn drug over fears they are contaminated with a cancer-causing chemical
- The medicines affected are prescription-only and not sold over the counter
- Supplies of ranitidine, the generic ingredient, are affected in the UK and US
- Medicine watchdogs said people should not stop taking their medicines
- But healthcare professionals should not keep prescribing the medications
- Ranitidine drugs made by the companies Creo Pharma and Tillomed are recalled
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.
WHAT IS NDMA?
NDMA is the acronym for N-Nitrosodimethylamine, a chemical byproduct of many industrial manufacturing processes.
The compound can be disruptive to DNA, which may cause cancer.
It doesn’t degrade, or break down, naturally in the environment or our bodies, meaning that it accumulates over time and our exposures only build up, earning it the nickname ‘forever chemical’.
NDMA is created in the production of rocket fuel, from which it has leached into our water supply.
It’s also common in low quantities in many foods, such as cured or smoked meats, fish and beer as well as tobacco smoke.
Animal studies have shown the chemical to cause colorectal, kidney, stomach and kidney cancers at high exposures.
In humans, on the other hand, studies have only linked the chemical to higher risks of cancers.
No human cases of cancer caused by NDMA have been reported, and the World Health Organization (WHO) considers it a ‘probable’ human carcinogen.
‘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 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.
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 the 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 Sivem 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– Creo Pharma and Tillomed Laboratories recall their 150mg ranitidine tablets and 30mg/ml oral solution, respectively
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