Heartburn drug Zantac is recalled WORLDWIDE amid fears it may contain 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
Pharmaceutical giant GlaxoSmithKline has recalled all of its Zantac products across the world amid fears they may be unsafe.
The pills may contain traces of NDMA, or N-nitrosodimethylamine, a chemical that is believed to be ‘probably carcinogenic’ to humans.
GSK has already pulled its common heartburn drug from shelves in Ireland, India and Hong Kong in separate moves up to two weeks ago.
It is currently unclear why it has taken longer to recall Zantac from other countries, including the UK. GSK does not market its drug in the US.
GSK yesterday announced that four types of prescription-only Zantac medication were being recalled in the UK.
However, over-the-counter Zantac products are made by different companies and are not affected, health officials announced.
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.
Officials said they are still investigating the safety of other medicines containing ranitidine, which is the key ingredient in Zantac.
A GSK spokesperson said: ‘GSK has made the decision to initiate a voluntary recall of Zantac products in all markets as a precautionary action.’
The MHRA said companies had all been told to stop supplying the affected Zantac products immediately and quarantine all remaining stock.
But the Government-run body said patients should continue taking their medication unless told otherwise by their doctor.
The four UK products affected by the recall are Zantac 150mg/10ml Syrup, Zantac 50mg/2ml Injection, Zantac 150mg Tablets and Zantac 300mg Tablets.
Over-the-counter versions Zantac 75 Relief and Zantac 75 Tablets are produced by Omega Pharma, based in Ireland and the US, and are not affected by this recall.
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
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’
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
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.’
US-based online pharmacy Valisure first discovered some Zantac products and generic ranitidine medications contained traces of NDMA in June.
It filed a petition to the The Food and Drug Administration (FDA), asking the agency to recall all products containing ranitidine.
Valisure’s 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.
The FDA issued a warning on the back of the petition on September 13, which sparked an investigation into ranitidine by The European Medicines Agency.
Italian health chiefs were the first to recall more than 500 drugs containing ranitidine made by Indian manufacturer Saraca Laboratories because of the NDMA impurity fears on September 20.
Three days later the Irish equivalent to the MHRA – the Health Products Regulatory Authority – pulled 13 medications containing ranitidine, including seven versions of Zantac.
Canada, India, France and Hong Kong all also pulled ranitidine medications from shelves last month.
US retailer CVS recalled Zantac, as well as some generic versions of the medication, after officials found some pills contained traces of NDMA.
GSK recalled four different types of Zantac in Hong Kong on September 24. The next day, it pulled the drug in India, where it is branded as Zinetac. It also halted global distribution of the popular medicine.
MailOnline has asked why it has taken GSK weeks to pull the potentially-dangerous drugs from UK shelves.
A spokesperson for GSK added that it is still investigating the potential source of the NDMA and that ‘patient safety remains our utmost priority’.
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.
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.
WHAT ARE THE ZANTAC PRODUCTS THAT HAVE BEEN RECALLED IN THE UK?
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.
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