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 are made by a different company 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.
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.
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.
The four products affected by the recall are Zantac 150mg/10ml Syrup, Zantac 50mg/2ml Injection, Zantac 150mg Tablets and Zantac 300mg Tablets. All four are prescription only medicines.
Over-the-counter products Zantac 75 Relief and Zantac 75 Tablets are produced by a different company and are not affected by this recall, the MHRA said.