POPULAR heartburn drug Zantac has been urgently recalled in the US and Canada over fears it could contain cancer-causing chemicals.
Drugmaker Sanofi announced on Friday it would be recalling the over-the-counter heartburn and ulcer drug because of possible contamination.
It comes a month after the Food and Drug Administration said a potentially cancer-causing chemical had been detected in versions of Zantac.
They started reviewing the safety of ranitidine, which is commonly sold as Zantac, after an online pharmacy called Valisure notified them that it had found impurities in the drugs.
A review of the drug found unacceptable levels of a substance called N-nitrosodimethylamine (NDMA), which has been listed as a probable human carcinogen.
Sanofi is now pulling the drug off shelves following recalls of the drug in other countries – including the UK.
Four types of prescription-only Zantac, used to treat heartburn and stomach ulcers, were urgently withdrawn in the UK last week.
On Thursday, two more products were added to the list – Ranitidine Effervescent Tablets 150 milligrams and 300 milligrams.
MORE TESTS NEEDED
The FDA has asked Zantac makers to conduct their own testing to assess levels of the impurity and to send samples of their products for testing by the agency.
Canada has requested drugmakers halt distribution of the drug while it gathers more information.
Sanofi CEO Paul Hudson, speaking at a press conference in Framingham, Massachusetts, earlier this week, downplayed concerns about the drug.
“We don’t believe there’s a risk,” Mr Hudson said on Tuesday.
“But we have to – and are appropriately duty bound to – satisfy the regulators, which we will do, and we’ll move on from there.”
OFF THE SHELVES
Other drugmakers including GlaxoSmithKline and Novartis have recalled or halted distribution of their versions of the drug.
Retailers and pharmacy chains including Walmart Inc CVS Health Corp, Walgreens Boots Alliance Inc and Rite Aid Corp have suspended the sale of drugs containing ranitidine.
The FDA has said it does not have enough scientific evidence yet to determine how long NDMA has been present in ranitidine.
But Valisure – the online pharmacy that flagged the issue to regulators – believes the problem is inherent to the drug itself and NDMA may have been present as long as it has been on the market.
NDMA (N-nitrosodimethylamine) was once used to make rocket fuel, according to the Centers for Disease Control and Prevention (CDC) in the US.
People are typically exposed to NDMA from a variety of sources, including tobacco smoke, chewing tobacco, diet (from cured meats for example) and toiletries and other cosmetic products.
It can harm the liver, and while there are no reports of NDMA causing cancer in humans, the CDC warns, “it is reasonable to expect that exposure to NDMA by eating, drinking or breathing could cause cancer in humans”.
Ranitidine is the latest drug in which cancer-causing impurities have been found.
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Regulators have been recalling some blood pressure and heart failure medicines since last year.
If you are worried, speak to your pharmacist or GP.