Breaking News – Zantac syrup, made by Lannett, has been recalled too.
Have you heard the news that taking ranitidine (Zantac) could cause cancer?
I’d be surprised if you haven’t…
Does Zantac Cause Cancer?
So does Zantac really cause cancer or is this just media hype?
“The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name drug Zantac, contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) at low levels. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”FDA Statement alerting patients and health care professionals of NDMA found in samples of ranitidine
Ok, so Zantac might contain NDMA and NDMA could cause cancer.
But NDMA is found in many things, so how concerned should we be about it being in Zantac?
“Although NDMA may cause harm in large amounts, the levels the FDA is finding in ranitidine from preliminary tests barely exceed amounts you might expect to find in common foods.”FDA Statement alerting patients and health care professionals of NDMA found in samples of ranitidine
Although the FDA is still “evaluating whether the low levels of NDMA in ranitidine pose a risk to patients,” so far, it doesn’t sound like a very big concern.
While Novartis AG’s Sandoz division, which makes ranitidine, has stopped distributing their generic version of Zantac, Sanofi will continue to distribute brand name Zantac. And many other companies make ranitidine, so it will likely continue to be available.
Most companies are voluntarily recalling their prescription and over-the-counter versions of ranitidine tablets, capsules, and syrup.
How do medications become contaminated with NDMA?
In the case of blood pressure medications (sartans), regulators began looking for NDMA last year.
“It is now known that these impurities can form during the production of sartans that contain a specific ring structure known as a tetrazole ring under certain conditions and when certain solvents, reagents, and other raw materials are used. In addition, it is possible that impurities were present in some sartans because manufacturers had inadvertently used contaminated equipment or reagents in the manufacturing process.”Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities
Ranitidine doesn’t contain a tetrazole ring, but as with the sartans, it is possible that the NDMA formed during production or that contaminated equipment or reagents were used in the manufacturing process.
“Valisure’s research, along with that of Stanford University and others, found that NDMA was the result of the “inherent instability” of the ranitidine molecule.”Valisure Detects NDMA in Ranitidine
“The typical diet in most countries contains nitrates, nitrites, and nitrosamines. Nitrates and nitrites occur naturally in fruit and vegetables, which are regarded as an important part of a healthy diet due to the powerful evidence of beneficial health effects against cancer. In the same time, nitrates and nitrites are often used as food additives in processed meats such as ham, bacon, sausages, and hot dogs, to retard microbial spoilage, and preserve meat products recognizable appearance and flavor as well. A high consumption of processed meats is linked to an increased gastric cancer risk, and many people consider nitrates/nitrites as the main reason for that. Nitrosamines are produced by chemical reactions of nitrates, nitrites and other proteins.”Song et al on Dietary Nitrates, Nitrites, and Nitrosamines Intake and the Risk of Gastric Cancer: A Meta-Analysis
NDMA is not in food because of contamination.
“…excess lifetime cancer risk was calculated separately for each of the five nitrosamines and then summed to arrive at a total excess lifetime cancer risk of 1.46 × 10-6 (or about 1 in 683,000) due to average population exposure to nitrosamines through pork bacon.”Cancer Risk from Nitrosamines in Pork Bacon
And the cancer risk from NDMA in food is considered to be small.
“Nitrosamines are ubiquitous in the human environment and have been detected in food items, including cured meat, bacon, fish, and beer, in cosmetics, drugs, and in the front passenger areas of new cars.”Exposure to high concentrations of nitrosamines and cancer mortality among a cohort of rubber workers
The bigger risk is likely from nitrosamines in cigarette smoke and occupational exposures.
What should you do if your child takes ranitidine?
Still, do you want to give your kids a medicine that might contain a substance that could cause cancer?
“The FDA is not calling for individuals to stop taking ranitidine at this time; however, patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options. People taking OTC ranitidine could consider using other OTC medicines approved for their condition. There are multiple drugs on the market that are approved for the same or similar uses as ranitidine.”FDA Statement alerting patients and health care professionals of NDMA found in samples of ranitidine
Since the risk seems so small, whether or not you continue giving your child Zantac or you switch to something else might depend on how easy it would be to switch.
Over the counter Zantac is approved for adults and children 12 years and over. There are many options to treat reflux for these folks, including Pepcid, Prevacid, Nexium, and Prilosec, etc.
On the other hand, prescription ranitidine syrup is approved for infants as young as one-month-old. Not many medicines are approved at this age.
There is one though.
Although not an H2-receptor antagonists like ranitidine, Nexium is another reflux medicine that is approved for infants. It is a proton pump inhibitor (also decreases the production of acid in the stomach) that is available in delayed release oral suspension packets.
Should you stop taking Zantac?
So what should you do?
Although doing nothing or switching seem like your two options, if your child’s reflux has been well controlled on Zantac for awhile, this might be a good idea to ask your pediatrician if a trial off medications might be appropriate.
Most infants and children eventually outgrow having reflux and are able to wean off their reflux medicine. Is your child ready?
Of course, you shouldn’t stop your child’s medicine without talking to your doctor first. And instead of stopping their Zantac, it might be better to switch to another reflux medicine.
“Carcinogens do not cause cancer at all times, under all circumstances.”American Cancer Society on Known and Probable Human Carcinogens
Could you keep taking Zantac? That’s also an option for now, especially if you only expect that your child will be on it for a short time, but as more manufactures declare that they will recall and stop shipping ranitidine, you might have to switch anyway.
Whatever you do, don’t panic over this news. Your kids are almost certainly not at any real increased risk to develop cancer just because they have been taking Zantac.
More on NDMA in Zantac
- Treating Hard to Control Reflux
- Health Canada requests that companies stop distributing ranitidine drugs in Canada while it assesses NDMA; some products being recalled
- Valisure Detects NDMA in Ranitidine
- FDA – FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)
- FDA – Statement alerting patients and health care professionals of NDMA found in samples of ranitidine
- FDA – Zantac (ranitidine): Safety Information – NDMA Found in Samples of Some Ranitidine Medicines
- FDA – Lannett Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/ml due to an Elevated Level of the Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
- EMA to review ranitidine medicines following detection of NDMA
- Sartan medicines: companies to review manufacturing processes to avoid presence of nitrosamine impurities
- Study – Dietary Nitrates, Nitrites, and Nitrosamines Intake and the Risk of Gastric Cancer: A Meta-Analysis
- Exposure to high concentrations of nitrosamines and cancer mortality among a cohort of rubber workers
- Tobacco-specific nitrosamines, an important group of carcinogens in tobacco and tobacco smoke.
- N-Nitrosamines – National Toxicology Program
- Cancer Risk from Nitrosamines in Pork Bacon
- General Information About Carcinogens
- Treatment for GER & GERD in Infants
- Parent’s Checklist for REFLUX in Infants 0-12 months old
- Teen Reflux Checklist
- Nexium Packets for acid reflux
Updated: October 30, 2019
Last Updated on October 30, 2019 by Vincent Iannelli, MD