FDA says ALL Zantac must be pulled from shelves over cancer fears
FDA says ALL Zantac must be pulled from shelves months after officials warned the popular heartburn drug is contaminated with cancer-causing chemicals
- The FDA told drugmakers on Wednesday to pull all Zantac and ranitidine – its generic version – from store shelves and online retailers in the US
- Evidence of a cancer-linked chemical called NDMA was first found in batches of the drugs in September 2019
- NDMA is considered a ‘probable’ cause of colorectal, kidney and stomach cancers based on animal studies
- FDA officials initially said the risk was relatively low and said patients should keep taking the popular heartburn drugs
- Now they’ve reversed that decision and said the levels of the chemical are ‘unacceptable’
- Anyone with Zantac or ranitidine should throw away the tablets, FDA says
US health official are demanding drugmakers immediately pull their popular heartburn drugs off the market after determining that a contamination issue with the medications poses a greater risk than previously thought.
Animal studies suggest the chemical found last year in Zantac and its generics, NDMA, may be linked to colorectal, kidney, and stomach cancers.
The move from the Food and Drug Administration Wednesday applies to all prescription and over-the-counter versions of ranitidine, best known by the brand name Zantac. The drugs are widely used to treat stomach acid and ulcers.
Patients should stop taking any of the medications they currently have and throw them away, the FDA said.
The agency last year said patients could continue taking the medications and did not face health risks from contamination with a ‘probable’ cancer-causing chemical found in multiple brands.
But officials reversed that decision, saying they’ve now determined that levels of the chemical increase over time, especially if tablets and capsules are stored at higher temperatures. That poses an unacceptable risk to patients, they said.
FILE – This Sept. 30, 2019 file photo shows a box of Zantac tablets at a pharmacy in Miami Beach, Fla. On Wednesday, April 1, 2020, U.S. health regulators are telling drugmakers to immediately pull their popular heartburn drugs off the market after determining that a contamination issue with the medications poses a greater risk than previously thought. The warning applies to all prescription and over-the-counter versions of ranitidine, best known by the brand name Zantac. (AP Photo/Wilfredo Lee, File)
‘Since we don’t know how or for how long the product might have been stored, we decided that it should not be available to consumers and patients,’ said Dr. Janet Woodcock in a statement.
Woodcock said there are multiple alternative medications to treat heartburn, including Prilosec, Nexium and Tagament.
Many makers of ranitidine drugs already removed their products from the market, including Zantac-manufacturer Sanofi. Additionally several drug store chains pulled the drugs from their shelves last year.
Dozens of recalls have been linked to the same probable carcinogen since last year. The FDA is still investigating the issue and has sanctioned at least one manufacturing plant in India that makes ingredients used in the medications.
The FDA has suspended nearly all U.S. and foreign inspections due to travel restrictions caused by the coronavirus outbreak.
Recalls of Zantac and its generics started rolling out in September of last year – and have slowed but not stopped since.
Since then, hundreds of batches of ranitidine drugs have been recalled.
The panic over ranitidine is due to amounts of a carcinogen called NDMA above the level deemed safe by US regulators found in the popular heartburn drugs.
NDMA – the short-hand for N-Nitrosodimethylamine – is labelled a ‘probable’ human carcinogen, and has caused liver, lung and other cancers in animal studies.
ALTERNATIVES TO CANCER-LINKED ZANTAC FOR HEARTBURN
Zantac and its active ingredient, ranitidine are members of a class of drugs called H2 blockers.
In recent years, doctors have preferred to prescribe this group of this drugs for patients with less severe heartburn.
Aside from ranitidine, or Zantac, patients can also take:
- Nizatidine (known by the brand name Axide)
- Famotidine (sold as Pepcid and Pepcid AC) and
- Cimetidine (sold as Taagamet and Tagemet HB)
These drugs all block certain receptors that trigger the release of stomach acid.
Although the FDA is now investigating heartburn drugs broadly, there have not yet been reports of NDMA linked to any of the other H2 blockers.
The other most commonly-used class of drug for heartburn is proton-pump inhibitors (PPIs).
- The blockbuster ‘purple pill,’ Nexium (sold generically as esomeprazole magnesium)
- Pirlosec (omeprazole)
- lansoprazole (Prevacid)
- Pantoprazole (Protonix)
PPIs block the final stage of acid production in the stomach, helping soothe symptoms for reflux sufferers.
These are highly effective and are recommended for people with more severe acid reflux as they reduce the risks for developing complications, like esophageal cancer, that can arise if the condition persists, untreated.
But they interfere with he way the body absorbs nutrients like magnesium and B12 and people that are on high doses for too long may be at higher risk for C diff infections and kidney disease.
‘We need to take a step back and say “why are people on this any way when there are more natural ways to treat symptoms?”‘ said Dr Hussain.
She noted that dietary changes, making sure to leave plenty of time between dinner and going to bed and wearing lighter, looser garments can help keep acid from pushing up from our stomachs. and causing heartburn.
There’s even an all natural treatment that uses algae to fight heartburn, called Reflux Gourmet, which she suggests to many patients.
And many don’t really need to treat a gastric issue, but simply the occasional symptoms.
‘There’s a different category of medications for active symptoms of heart burn, and the best thing is Tums because that works immediate, but you would take them to stop it, but not to prevent heartburn,’ said Dr Hussain.
A number of theories have been put forward to explain how the toxic chemical ended up in the supply of some heartburn medications, as well as in the blood pressure drugs, valsartan and losartan, in recent years.
Some have suggested it’s a result of shoddy manufacturing.
Others initially suggested that the way the body metabolizes the drug could actually make levels of NDMA surge in the stomach, but that theory was debunked in November, to the relief of heartburn sufferers.
Zantac and its generics have been purged in waves from store shelves and retail sites worldwide, but its makers in the US and Canada were among the last to follow-suit.
WHAT IS NDMA, THE CANCER-LINKED TOXIN FOUND IN ZANTAC?
NDMA is 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 definitively 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.
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