Zantac is pulled from shelves in the UK: Health officials recall the common heartburn drug over fears it contains a cancer-causing chemical
- GlaxoSmithKline said four different types of the medication would be recalled
- It’s feared pills contain NDMA, considered ‘probably carcinogenic’ to humans
- All four affected products are only available on prescription in UK, MHRA said
- Over-counter Zantac is made by different company and not affected by recall
The manufacturer of common heartburn drug Zantac has recalled several batches over fears they could contain a cancer-causing chemical.
GlaxoSmithKline announced four different types of the medication, all only available on prescription, would be recalled.
Over-the-counter Zantac products, which people can buy without a prescription, are made by a different pharmaceutical firm and are not affected by the recall.
It is feared some pills may contain traces of NDMA, or N-nitrosodimethylamine – considered to be ‘probably carcinogenic’ to humans.
Health chiefs in the UK today told companies to stop supplying the affected Zantac products immediately and quarantine all remaining stock.
After the FDA discovered trace amounts of a carcinogen in Zantac’s active ingredient, ranitidine, CVS said Saturday it would suspend sales of the popular heartburn drugs (file)
The Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs in the UK, issued the alert.
But it said patients should keep taking their medication unless told otherwise by their doctor.
Irish health officials recalled 13 products containing ranitidine, the main ingredient in Zantac, at the end of last month.
The Irish equivalent to the MHRA – the Health Products Regulatory Authority – said the fault comes from the manufacturing plant in India.
US retailer CVS also pulled Zantac as well as some generic versions from its shelves after officials found some pills contained traces of NDMA.
WHAT ARE THE ZANTAC PRODUCTS THAT HAVE BEEN RECALLED?
GlaxoSmithKline has announced a UK-wide recall of four prescription-only types of Zantac, a common heartburn drug.
It is feared some pills may contain traces of NDMA, or N-nitrosodimethylamine – considered to be ‘probably carcinogenic’ to humans.
The affected products are:
- Zantac 150mg/10ml Syrup
- Zantac 50mg/2ml Injection
- Zantac 150mg Tablets
- Zantac 300mg Tablets
Over-the-counter versions of Zantac (75 Relief and 75 Tablets) are not affected by the recall. They are produced by a different company.
The MHRA said that it is still investigating the safety of other medicines containing ranitidine, which is the main ingredient in Zantac.
Dr Andrew Gray, MHRA’s deputy director of inspections, enforcement and 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.
‘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 world.’
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.
Several medical studies have linked NDMA to colorectal, stomach, liver and kidney cancers in animals. Evidence on humans is scarce.
The Food and Drug Administration (FDA) was the first to discover some batches of ranitidine pills contained trace amounts of NDMA.
Its announcement on September 13 then sparked an investigation into the safety of ranitidine by The European Medicines Agency.
An MHRA spokesperson said at the time it was ‘monitoring the issue’ and would take ‘appropriate action if necessary’.
When asked by MailOnline last month, the body added it had not yet initiated any product recalls – unlike its Irish counterpart.
REVEALED, HOW THE ZANTAC SCANDAL UNFOLDED
SEPTEMBER 13 – The US Food and Drug Administration (FDA) discovers some batches of ranitidine pills, including Zantac, contain trace amounts of NDMA.
The announcement sparks an investigation into the safety of ranitidine by The European Medicines Agency.
An MHRA spokesperson says the body is ‘monitoring the issue’ and will take ‘appropriate action if necessary’.
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
SEPTEMBER 25 – GlaxoSmithKline recalls the drug in India, where it is branded as Zinetac
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 – The UK Medicines and Healthcare products Regulatory Agency (MHRA) tells companies to stop selling four prescription-only types of Zantac
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