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 as far back as two weeks ago.

It is currently unclear why it has taken longer for GSK to recall Zantac from the other countries that it markets in, including the UK.

GSK does not sell its drug in the US, where retailers such as CVS and Walmart have already chosen to pull ranitidine from their shelves over the same safety fears.

Other ranitidine products are still available in both the UK and US because neither country has issued formal recalls of the entire drug supply, instead they have just issued alerts about drastic moves made by firms such as GSK.

The GSK recall has sparked panic among patients taking the common heartburn drugs, including one new mother who said she was ‘freaking out’.

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)

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)

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)

GSK's stock appears to have been unaffected by the announcement of the company. Shares in the pharmaceutical giant were priced at 1,720.40 on the London Stock Exchange this afternoon, up 0.43 per cent

GSK's stock appears to have been unaffected by the announcement of the company. Shares in the pharmaceutical giant were priced at 1,720.40 on the London Stock Exchange this afternoon, up 0.43 per cent

GSK’s stock appears to have been unaffected by the announcement of the company. Shares in the pharmaceutical giant were priced at 1,720.40 on the London Stock Exchange this afternoon, up 0.43 per cent

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 firm, which is headquartered in Brentford, UK, did not confirm what markets these were when asked by MailOnline.

GSK’s stock appears to have been unaffected. Shares were priced at 1,720.40 on the London Stock Exchange this afternoon, up 0.43 per cent.

US-based online pharmacy Valisure first discovered some Zantac products and generic ranitidine medications contained traces of NDMA in June.

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.

UK-based watchdog the MHRA says there is no evidence medicines containing nitrosamines have caused any harm to patients.

Mother-of-two Tammy took to Twitter in a panic after the recall, revealing she had been taking the heartburn drugs every day for two-and-a-half years

Mother-of-two Tammy took to Twitter in a panic after the recall, revealing she had been taking the heartburn drugs every day for two-and-a-half years

Mother-of-two Tammy took to Twitter in a panic after the recall, revealing she had been taking the heartburn drugs every day for two-and-a-half years

Kayla tweeted that she was prescribed Zantac during her pregnancy and was concerned it would have an effect on her baby

Kayla tweeted that she was prescribed Zantac during her pregnancy and was concerned it would have an effect on her baby

Kayla tweeted that she was prescribed Zantac during her pregnancy and was concerned it would have an effect on her baby

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

The body mirrored the statement from the US-based FDA that said patients taking affected drugs should talk to their doctor before stopping them.

The NHS says acid reflux, which causes heartburn, raises the chances of developing oesophageal cancer – but admits the risk is small.

Janet Woodcock, director of the FDA’s Centre for Drug Evaluation and Research, said the agency would keep the public information of any other recalls and potential risks.

The four UK products affected by the GSK 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.

However, two other over-the-counter Zantac products made by different companies were not affected, the MHRA revealed in a health alert.

The body said companies had all been told to stop supplying the affected Zantac products immediately and quarantine all remaining stock.

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.

‘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.’

Mothers who had been prescribed Zantac while pregnant took to Twitter to raise their fears.

Paula Reeves wrote: ‘My baby has been on it for 5.5 months. I’ve successfully weaned her off it now but gosh what a worry!’

Another recent mother, Tracey Maree, replied: ‘My newborn has been on Zantac for the first three months of his life… we have also weaned [him] off but I am freaking out.’

Many patients were left wondering what medicine, if not Zantac, they should take to remedy their heartburn.

Richard Bulles wrote: ‘Great. Been taking generic Ranitidine for at least 4 years whenever I needed acid relief. What else will work as well in pill form?’

Mother Kim was also taking the drugs during her two pregnancies and admitted she was scared about the news they may cause cancer

Mother Kim was also taking the drugs during her two pregnancies and admitted she was scared about the news they may cause cancer

Mother Kim was also taking the drugs during her two pregnancies and admitted she was scared about the news they may cause cancer

Courtney revealed her daughter was prescribed the heartburn drug and used it regularly as a baby

Courtney revealed her daughter was prescribed the heartburn drug and used it regularly as a baby

Courtney revealed her daughter was prescribed the heartburn drug and used it regularly as a baby 

Similarly, Amanda Weaver's daughter took liquid Zantac - one of the products recalled in the UK - for her first year of life

Similarly, Amanda Weaver's daughter took liquid Zantac - one of the products recalled in the UK - for her first year of life

Similarly, Amanda Weaver’s daughter took liquid Zantac – one of the products recalled in the UK – for her first year of life

RECALL SPARKS FEAR AMONG PATIENTS AND PARENTS

News of the mass recall sent former and current users of the common heartburn drugs into a state of panic.

Mothers who had been prescribed Zantac while pregnant took to Twitter to raise their fears. 

Paula Reeves wrote: ‘My baby has been on it for 5.5 months. I’ve successfully weaned her off it now but gosh what a worry!’

Another recent mother, Tracey Maree, replied: ‘My newborn has been on Zantac for the first three months of his life… we have also weaned [him] off but I am freaking out’.

Mother-of-two Tammy revealed she had been taking the heartburn drugs every day for two-and-a-half years and was shocked to hear it may cause cancer.

Many patients were left wondering what medicine, if not Zantac, they should take to remedy their heartburn.

Richard Bulles wrote: ‘Great. Been taking generic Ranitidine for at least 4 years whenever I needed acid relief. What else will work as well in pill form?’ 

The Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs in the UK, has advised patients continue to take the prescribed drugs.

It said people should only stop if told to do so by their doctor. 

Valisure’s initial 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.

Italian health chiefs were the first to recall more than 500 drugs containing ranitidine made by Indian manufacturer Saraca Laboratories 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.

CVS, Walgreens, Walmart and Rite Aid in the US have all since recalled Zantac, as well as some generic versions of the medication.

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. 

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.

DailyMail Online


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