Contaminated heartburn drugs including Zantac and supermarket own-brands ‘are ALL off the shelves’ after months of recalls, health officials claim
- GPs ordered to wean patients off drugs or switch them to alternative versions
- Comes after cancer-causing chemical found in batches of the heartburn drugs
- NHS figures show almost 6 million prescriptions dished out for them last year
A popular heartburn and indigestion drug has been completely pulled from supermarket shelves amid a global contamination scandal, health bosses claim.
The Department of Health and Social Care (DoHS) said all versions of ranitidine, including Zantac, had been quarantined after months of recalls.
And it has banned doctors from prescribing them until further notice, over fears they contain a cancer-causing chemical.
The DoHS has prohibited doctors from starting new patients on tablet, injectable or liquid versions while experts probe their safety.
Instead, the government is advising medics to switch patients to alternative medications.
NHS figures show almost six million prescriptions were dished out for ranitidine in England last year.
British doctors have been banned from prescribing any form of Zantac- a popular heartburn and indigestion drug over fears they may cause cancer (file)
The Department of Health and Social Care (DoHS) has ordered GPs to wean patients off the drugs – which also come in liquid (shown) and injectable form
It comes after a string of recalls of ranitidine following the discovery of N-nitrosodimethylamine (NDMA) contamination.
NDMA, used in gas and rocket fuel, has been deemed ‘probably carcinogenic by the World Health Organisation (WHO).
The DoHS said in a statement: ‘As investigations into ranitidine have progressed, the Medicines and Healthcare Products Regulatory Agency have instructed suppliers of both oral and injectable ranitidine in the UK to quarantine all affected, unreleased stock at manufacturer level while their investigations are ongoing.’
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.
Meanwhile, the NHS has advised patients through its website to ‘try to speak to your doctor before your ranitidine runs out’.
‘There are similar medicines they can prescribe for you if you still need it. In the meantime, keep taking your medicine as usual,’ it said.
Recalls first began after tests in the US discovered traces of NDMA in some branded Zantac products in June.
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.
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.
But health officials in various countries instead suspect the fault comes from the manufacturing plant of the chemical in India.
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.
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 WHO’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.
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