Fears heartburn drug ranitidine may contain a cancer-causing chemical

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. 

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.