Tag: acid reflux

Does Zantac Cause Cancer?

Breaking News – In Canada, companies marketing ranitidine products have stopped any further distribution until evidence is provided to demonstrate that they do not contain NDMA above acceptable levels.

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.

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

And food?

“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 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

Acid reflux is common, especially for newborns and infants.

Many parents are surprised to know that reflux can affect older kids too though. Fortunately, reflux is temporary for most of these kids and can be easily treated.

It can be even easier to treat younger kids, most of whom don’t need any treatment if they are just messy and don’t have true acid reflux disease.

Happy Spitters and Reflux Symptoms

Children who spit up have acid reflux or more specifically gastroesophageal reflux (GER).

Many babies spit up or have reflux.
Many babies spit up or have reflux, but most are just “happy spitters” and don’t need treatment. Photo by Ryan Dickey (CC BY 2.0)

They may not have acid reflux disease though (GERD), with other associated signs and symptoms, such as:

  • refusing to eat
  • recurrent vomiting
  • weight loss or poor weight gain (failure to thrive)
  • irritability or trouble sleeping
  • respiratory symptoms, such as a chronic cough, hoarse voice or cry, or hard to control asthma, etc.
  • Sandifer syndrome – reflux plus head tilting and back arching

Without any of these symptoms, your baby who spits up, even if it is very frequent and it seems like they spit up a large amount each time, is likely what is classically called a “happy spitter.” If they are just messy, they don’t need any treatment and you can wait until they outgrow their reflux.

Remember – “Spit Happens.”

Older children with acid reflux might complain of heartburn, chest pain, or say that they have a sour taste in their mouth (sour burps).

Lifestyle Changes for Reflux

Once you recognize that your child has GERD and needs to be treated, you might start with these lifestyle changes:

  • avoiding milk and dairy products for two to four weeks if you are breastfeeding an infant with GERD
  • changing baby formula to an extensively hydrolyzed protein (Nutramigen, Gerber Extensive HA, Alimentum) or amino acid–based infant formula if your formula fed baby has GERD
  • thickening your baby’s formula (typically about one tablespoon of rice cereal per every one to two ounces of formula) vs switching to a baby formula for reflux (Enfamil AR or Similac Sensitive R.S.)
  • making sure you aren’t overfeeding your baby, including that you don’t re-feed your baby right after they spit up
  • avoiding seated and supine (on his back) positions after feedings, although you shouldn’t put your baby down prone (on his stomach) if he is going to fall asleep (risk factor for SIDS)
  • helping older children with acid reflux lose weight if they are overweight and making sure they don’t smoke or drink alcohol
  • encouraging older children to avoid acid reflux triggers, especially caffeine, chocolate, foods with acid, and spicy foods

When can you expect your infant’s reflux to go away? In most babies, reflux symptoms peak at about 4 months and go away by the time they are 12 to 18 months old. In older children, reflux symptoms generally go away after a few months of appropriate treatment.

Acid Reflux Medicines

If lifestyle changes aren’t working, your child with reflux likely needs medicine to treat his reflux.

These acid reflux medications include:

  • antacids – may be okay in older children with very rare symptoms, but not for routine use
  • histamine-2 receptor antagonists (H2RAs) – such as Zantac (ranitidine) – works quickly, but may stop working over time (tachyphylaxis)
  • proton pump inhibitors (PPIs) – such as Prevacid (over-the-counter for adults) and Nexium (Nexium packets are FDA approved for infants) – considered more potent and superior to H2RAs but may take up to four days to start working
  • prokinetic agents – rarely used because of side-effects

In general, if your child’s symptoms improve or go away within two weeks of taking an acid reflux medication, then you should likely continue it for at least two to three months.

Treating Hard to Control Reflux

What do you do when lifestyle changes and reflux medicines don’t work or symptoms return after you stop your child’s reflux medicine?

First, make sure you are giving the right medicine, the right dosage of medicine, and are giving it at the right time, keeping in mind that PPIs should be giving 30 minutes before a meal.

Next, consider if there are any other lifestyle changes that you can try. For example, you might encourage your older child with persistent reflux to eat smaller meals more frequently, avoid a bedtime snack, and you may even elevate the head of his bed by about 30 degrees.

Lastly, you might make sure that your child really does have reflux.

Just because your baby is fussy and wakes up a lot at night, it doesn’t automatically mean that he has reflux. It could instead be colic, or be related to a food intolerance or allergy, with breastfeeding mothers needing to go on a more restrictive diet or infants drinking a hydrolyzed formula might need to switch to an elemental formula (Elecare, Neocate, or PurAmino).

Older kids with difficulty swallowing (dysphagia), which is often blamed on acid reflux, might have post-nasal drip caused by allergies or a sinus infection, etc.

And even if truly spitting up, instead of GERD, a child might have any number of other conditions instead of GERD, from an intestinal obstruction to a metabolic disorder.

It is usually at this point, when classic acid reflux treatments aren’t working, that a referral to a pediatric gastroenterologist would be a good idea.

What To Know About Acid Reflux

Acid reflux in kids is usually temporary and can often be controlled with lifestyle changes and medications, but unfortunately, acid reflux symptoms are not always caused by reflux, leading to some treatment failures.

For More Information on Acid Reflux