Zantac is finally pulled from US and Canada: Popular heartburn drug is recalled from North America a MONTH after it was found to contain cancer-causing chemicals and sales were halted in Europe and Asia
- In September, the FDA found low levels of of a cancer-causing chemical NDMA in Zantac and its generic ranitidine
- NDMA is linked to colorectal, gastric and kidney cancers in animal studies
- Detection of NDMA in blood pressure medication triggered worldwide recalls and shortages
- The company that sells prescription Zantac in other countries, GSK, recalled it and its generic worldwide earlier this month
- Walmart, CVS, Rite-Aid and other major retailers pulled the drug from shelves and online stores voluntarily in the US, but it could still be sold in other stores
- Sanofi, which sells the drug in the US finally recalled its over-the-counter and prescription versions of Zantac
Drugmaker Sanofi is recalling its over-the-counter heartburn drug Zantac in the U.S. and Canada because of possible contamination.
The French company Friday joined other drugmakers that have recently recalled their versions of the popular heartburn and ulcer drug.
In September, the Food and Drug Administration (FDA) said a chemical that may cause colorectal, gastric, and kidney cancers had been detected at low levels in prescription and over-the-counter versions of Zantac.
GlaxoSmithKline, which sells the drug outside of the US, halted sales of the drugs earlier this month and many major US retailers like Walmart, CVS and Rite Aid stopped selling it voluntarily.
Sanofi did not follow suit and continued selling the prescription and over-the-counter drugs in the US, until Friday.
The FDA said consumers could consider taking another heartburn medicine or contact their doctor, but stopped short of issuing a mandatory recall.
Sanofi, which sells over-the-counter and prescription Zantac in the US, finally recalled its versions of the popular heartburn drug on Friday, over a month after global sellers did the same in the wake of the FDA's discovery of NDMA, a chemical that may cause cancer, in it
WHAT IS NDMA, THE CANCER-LINKED TOXIN FOUND IN ZANTAC?
NDMA is the acronym for N-Nitrosodimethylamine, a chemical byproduct of many industrial manufacturing processes.
The compound can be disruptive to DNA, which may cause cancer.
It doesn't degrade, or break down, naturally in the environment or our bodies, meaning that it accumulates over time and our exposures only build up, earning it the nickname 'forever chemical.'
NDMA is created in the production of rocket fuel, from which it has leached into our water supply.
It's also common in low quantities in many foods, such as cured or smoked meats, fish and beer as well as tobacco smoke.
Animal studies have shown the chemical to cause colorectal, kidney, stomach and kidney cancers at high exposures.
In humans, on the other hand, studies have only linked the chemical to higher risks of cancers.
No human cases of cancer caused by NDMA have been reported, and the World Health Organization (WHO) considers it a 'probable' human carcinogen.
Earlier this year, it was found in an entire class of blood pressure drugs - the most widely known of which is valsartan - leading to worldwide recalls and shortages, despite the FDA's statement that the drug poses limited risks.
'There have been no adverse events' linked to Zantac, Dr Inna Hussain, head of laryngology at Rush University Medical Center told DailyMail.com.
'The concern is that at high enough doses, NDMA can be carcinogenic, but what does isn't clear.'
We don't know yet if NDMA got into ranitidine during its production or if the toxin is a byproduct of the drug itself.
It could be that Zantac 'is breaking down and becoming NDMA, which is much more concerning,' said Dr Hussain.
She notes that it's those who use the drug continuously for the management of chronic heartburn who are likely to be at the greatest risk.
WHERE WAS ZANTAC ALREADY RECALLED AND WHY IT STAYED ON US SHELVES SO LONG
The level of the chemical that the FDA considers 'unacceptable' is still low and, in fact, it was initially detected at alarming levels when an private pharmacy group used a more sensitive test on the samples of the drug.
The FDA then adjusted its own testing, found lower levels than that pharmacy, but high enough doses to exceed their threshold for safety, and advised company's making the drug perform similar tests.
A UK watchdog group announces Tuesday that GSK was recalling four of its forms of prescription Zantac: Zantac 150mg/10ml Syrup, Zantac 50mg/2ml Injection, Zantac 150mg Tablets and Zantac 300mg Tablets.
GSK recalled the products worldwide.
Other variation on the products were not recalled and can still be bought over the counter in the UK.
In the US, many makers of generic ranitidine, including pharmaceutical giants Apotex and Sandoz, have voluntarily recalled their heartburn drugs.
But Sanofi, which produces and sells brand-name Zantac, hasn't budged.
As far as the company is concerned, its drugs can remain on the shelves, though retail giants CVS, Walmart and Rite-Aid have all pulled Zantac of their own volition.
In fact, Sanofi seems to have said nothing more than its initial statement that it 'takes patient safety seriously and [is] committed to working with the FDA.'
'There are currently no plans to stop distributing or manufacturing Zantac or other Ranitidine products outside of Canada,' where officials issued a mandatory recall, said a Sanofi spokesperson in an email to DailyMail.com.
'The levels of NDMA found in ranitidine in preliminary tests barely exceed amounts found in common foods, we have no reason to believe that a recall is necessary at this point."
For now, the FDA is not advising anyone to stop taking the over-the-counter drug, but suggested that patients whose doctors had prescribed the Zantac or ranitidine should speak to their doctors about alternatives.
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