Boots and Morrisons’ own versions of Zantac are recalled as ANOTHER drug firm pulls batches of the heartburn medication amid fears they may contain a cancer-causing chemical
- Perrigo Company supplies ranitidine – the generic form of the heartburn drug
- But the pharmaceutical firm has announced a recall of eight types of its drug
- The recall includes two Boots-branded and one Morrisons-branded versions
- It is feared some pills may contain traces of NDMA, or N-nitrosodimethylamine
Boots and Morrisons have today been told to recall their own-brand versions of Zantac amid fears they may contain a cancer-causing chemical.
Perrigo Company supplies ranitidine – the generic form of the branded heartburn drug – to both of the British retail giants, as well as several others.
But the pharmaceutical firm has now announced a recall of eight types of its drug, including two Boots-branded and one Morrisons-branded versions.
Galpharm and Kirkland’s medications have also been affected, and so have two other forms of the most-recognised brand Zantac that Perrigo produces.
It is feared some ranitidine pills may contain traces of NDMA, or N-nitrosodimethylamine – a chemical considered to be carcinogenic to humans.
Major American retailers including Walmart and Walgreens have already pulled Zantac – and generic forms – from their shelves because of the cancer fears.
Perrigo Company supplies ranitidine – the generic form of the branded heartburn drug – to both of the British retail giants, as well as several others
But the pharmaceutical firm has now announced a recall of eight types of its drug, including two Boots-branded and one Morrisons-branded versions
Rosemont Pharmaceuticals Limited
Ranitidine 150mg/10ml Oral Solution
Omega Pharma Limited
Zantac 75 Relief Tablets
Zantac 75 Tablets
Galpharm International Limited
Galpharm Indigestion Relief 75mg Tablets
Boots Heartburn & Indigestion Relief 75mg Tablets
Kirkland Indigestion Relief 75mg Tablets
Morrisons Indigestion & Heartburn Relief 75mg Tablets
Boots Heartburn & Indigestion Relief 75mg Tablets
And other Zantac distributors in the UK, such as GlaxoSmithKline and Teva, have voluntarily recalled versions of their drugs over the same NDMA concern.
The latest alert, from Dublin-based Perrigo Company, was sent out by a UK watchdog which polices the safety of drugs.
One of the drugs that has been recalled is prescription-only. The rest are available over-the-counter, according to the alert.
The Medicines and Healthcare products Regulatory Agency (MHRA) said companies have been asked to quarantine all affected batches.
The Government-run body added there is no evidence NDMA causes harm to patients and that the Perrigo recall is only ‘precautionary’.
Spokesperson Dr Andrew Gray also urged patients to keep taking ranitidine and seek medical advice before stopping any prescribed medication.
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.
REVEALED, HOW THE ZANTAC SCANDAL 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
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.
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.
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