Cancer fears over heartburn drug Zantac spread to the UK after US retailer CVS pulls it from shelves and Irish regulators issue recall
- UK officials have yet to follow suit on the drastic decision to pull the medication
- Tests have showed the drug contains N-nitrosodimethylamine, also called NDMA
- Health experts consider the chemical to be ‘probably carcinogenic’ to humans
- NHS figures show 5.6million prescriptions were dished out for ranitidine in 2018
Fears that some batches of heartburn drug Zantac could contain a cancer-causing chemical have spread to the UK.
US retailer CVS has pulled the branded version of ranitidine, as well as some generic versions, from its shelves after officials found some pills contained traces of NDMA, or N-nitrosodimethylamine – considered to be ‘probably carcinogenic’ to humans.
Irish regulators have also recalled 13 different products over the same fears. All of the products were manufactured at a site in India.
UK officials have yet to follow suit on the drastic decision to pull the medication, called ranitidine – branded as Zantac, from the shelves.
But a watchdog said it had asked companies to quarantine some batches of the drugs amid an ongoing investigation into their safety.
NHS figures show almost six million prescriptions were dished out for ranitidine in England last year.
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 drug, which is also available over-the-counter, is given to patients to relieve heartburn and acid indigestion.
It is not the first medication to be recalled over fears it could contain NDMA.
The Medicines and Healthcare products Regulatory Agency (MHRA), which polices the safety of drugs in the UK, have pulled a series of heart drugs in the last year after tests revealed some batches contained NDMA or a similar chemical.
The Irish equivalent to the MHRA – the Health Products Regulatory Authority – said the fault comes from the manufacturing plant in India.
In a recall dated last week, the body said: ‘At present, there is no evidence that this impurity has caused any harm to patients.’
The notice the HPRA issued was undertaken as a ‘precautionary measure’ and does not affect patients.
It listed 13 different products being pulled from pharmacies and retailers – all of which were made at the manufacturing plant in India.
No further details have emerged about how the impurity came about from the plant in India, or exactly where it is located.
The Food and Drug Administration (FDA) was the first to discover some batches of the 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’.
An MHRA spokesperson today told MailOnline it was ‘not aware’ of any data as of yet to suggest there was any risk to patients.
The body added it was not currently initiating any product recalls – unlike its Irish counterpart.
But it said that it had asked companies to quarantine some batches of potentially affected drugs – none of which it named.
Canada and France have already announced recalls of Zantac, while Bangladesh imposed a ban on importing the drug at the weekend.
Novartis AG’s Sandoz unit said it was halting distribution of Zantac in all its markets, including the US, following the EMA safety review.
Several medical studies have linked NDMA to colorectal, stomach, liver and kidney cancers in animals. Evidence on humans is scarce.
Blood pressure drugs valsartan and losartan were found to be tainted with NDMA and a similar chemical called N-nitrosodiethylamine (NDEA).
Investigators narrowed it down to quality control failings at a Chinese supplier of the drug’s production at Zhejiang Huahai.
Experts said the contamination could date back as far as 2012, when the company changed its manufacturing process.
Factories in China and India are estimated to efficiently produce two-thirds of drug ingredients in the world, at a cheaper price.
TIMELINE OF COMMON BLOOD-PRESSURE DRUGS’ RECENT RECALLS
2012 – The blood-pressure medication valsartan is thought to have been contaminated with the cancer-causing, rocket-fuel chemical NDMA as far back as 2012.
European regulators warned last year the medication’s main manufacturer in China – Zhejiang Huahai Pharmaceutical – changed its manufacturing process seven years ago, which may have been to blame.
July 5, 2018 – The UK recalled the drug over growing concerns.
Many EU authorities then followed suit.
The European Medicines Agency said it was working to establish how long, and at what levels, patients might have been exposed to NDMA.
July 17 – The US Food and Drug Administration ordered a ban on valsartan’s prescription.
July 30 – China’s National Health and Family Planning Commission said the drug must not be used for diagnosis or treatment.
January 3, 2019 – The Medicines and Healthcare products Regulatory Agency (MHRA) recalled thousands of medications containing the blood-pressure drug irbesartan over NDEA fears.
The government-run body issued an alert over four batches of the medication and pulled the products – made by Actavis, now known as Accord – as a ‘precautionary measure’.
January 23, 2019 – Prinston Pharmaceutical Inc, a medicine company in the US, announced it was voluntarily recalling irbesartan and irbesartan HCTZ after finding higher levels of NDEA in them than the Food and Drug Administration permits.
January 24, 2019 – The UK’s MHRA issued a further recall of three more batches of irbesartan, this time concerning 150mg and 300mg film-coated tablets supplied by Macleods Pharma UK.