Zantac Pulled from Shelves due to Probable Cancer Causing Contaminant: What does this mean for me and my family?

For years, Zantac (the brand name for the drug ranitidine) and generic equivalents have been marketed as a safe, effective way of alleviating reflux, better known as heartburn. Millions have used this product to suppress reflux…but in recent days, CVS, Walgreens and other retailers have pulled these products from their shelves and in Canada the drug has been recalled.

Most people overdo it now and again, let’s admit it, with a little too much food and/or alcohol.  We have all done this when the company’s great and we’re having a bit too much fun or attending holiday parties. You know, you have that familiar burning in your chest and decide you need something to banish the discomfort quickly…so you reach for the Zantac.

Or, maybe you’re a new parent with a baby who screams, arches their back, and shows they are in pain after every feeding. You know first-hand that it’s not just adults who suffer from heartburn; your baby does, too. Just like when it’s your own reflux, and perhaps even more so, you want to make it better quickly. But Zantac probably isn’t the answer. In fact, as discussed below, what appears to be acid-related reflux in infants may be caused by other conditions.

In moments like these, what do you take now? What do you give your baby?  I’d like to give you more insight into the carcinogenic contaminant, NDMA, that instigated the recall, offer some thoughts on how to proceed if anyone in your family takes ranitidine, and share how we treat gastroesophageal reflux at GetzWell Pediatrics. Spoiler alert: We have always strived to avoid prescribing ranitidine in infants.

Once available only by prescription, Zantac became an over the counter medication several years ago and is one of the most widely used drugs on the market. The United States Food and Drug Administration (FDA) is alerting health care professionals and patients about a voluntary recall of over the counter (OTC) ranitidine tablets. (1) This voluntary drug recall comes after the FDA’s announcement on September 13, stating that they had “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.” (2)

As of September 28th, drugstore chains including CVS, Rite Aid, and Walgreens removed Zantac and other generic versions of ranitidine from their shelves while the FDA continues their investigation. (3).  More information about the situation will likely become available from the FDA over the coming days and weeks.  Individuals seeking alternate therapy to treat their condition should speak with us at GetzWell or other healthcare providers.

What is NDMA?

NDMA is an environmental contaminant that comes from industrial processes and certain pesticides. NDMA can be found in drinking water, dairy products, vegetables, and grilled or cured meats, and it can affect animals and humans through the liver. Studies have been done mostly on animals rather than humans—those studies form the basis for NDMA’s classification as a probable carcinogen (cause  of cancer).

How does GetzWell treat gastroesophageal reflux?

While it’s true that infant reflux often results in parental anxiety and accounts for numerous medical visits (4), it is usually benign and shouldn’t require treatment with pharmaceuticals. (Gastroesophageal reflux occurs when gastric contents slosh up from the stomach into the esophagus.) Furthermore, there is increasing evidence that the majority of symptoms parents observe in their “refluxy” babies may not be acid related. That said, ranitidine, much like antibiotics, is over-prescribed by well-meaning pediatricians whose main tool to help worried parents is their prescription pad. (5)

In one large 2017 study of 874,447 healthy children born within the Military Healthcare System from 2001 to 2013 they found approximately 10% of the children were given antacids in the first year of life. (6) While there are situations where babies’ gastroesophageal reflux causes symptoms so severe that medication may be necessary, most of the time, that’s just not the case. Additionally, several studies have shown that these medications are ineffective at treating symptoms associated with reflux in the absence of proven esophageal inflammation. (7)

Spitting up, or reflux, in infancy is a normal part of development, and it starts to wane as the sphincter at the top of the stomach tightens. The spit-up is mostly milk rather than stomach acid, and while messy, it’s not a cause for concern.

Rarely, stomach acid may be the problem and in fact irritates a child’s esophagus and lungs, causing pain, discomfort, and coughing, among other things. All of us, including babies, deserve relief from the pain and discomfort of heartburn. But rather than a prescription for ranitidine, which suppresses gastric acid and causes potential longer-term problems including GI and respiratory infections, bacterial and fungal overgrowth, adverse bone health, food allergy, and drug interactions, at GetzWell we use our larger toolbox to help us avoid medicating infants with pharmaceuticals.

One important and relatively easy way to ease babies’ gastroesophageal reflux is to adjust their position for feeds—we advise holding baby upright as much as possible while feeding him/her (wedges are available to assist). Burping, gentle and slow changes in position without excessive bouncing, as well as keeping baby upright after feedings for 20-30 minutes, are simple strategies that can do a lot to ease symptoms.

Beyond positioning, here are some other things to consider:

  1. For babies who are taking breast milk (either pumped or by nursing), elimination of dairy in mom’s (or the lactating person’s) diet may help significantly. Sometimes caffeine, wheat, corn, eggs, meat, nuts, and soy also trigger reflux or digestive discomfort for baby, but dairy is by far the most common irritant. We offer guidance on eliminating and reintroducing foods to help make this process as straightforward as possible.
  2. Plant-based digestive enzymes can also be useful. We keep them in stock at the office and can instruct you on their safe use.
  3. For babies who are formula feeding, it may be necessary to use a hydrolyzed milk protein formula, and we can provide guidance on what’s available and effective.

In addition to these suggestions for feeding, we offer pharmaceutical grade probiotics that have been shown to decrease infant crying time (8), safe and locally produced herbal remedies designed to aid digestion, and we’ll show you acupressure sites that will help calm the baby’s nervous system and promote forward/downward movement of GI contents.

We have so many tools in our GetzWell toolbox, and we love collaborating with families to find effective, personalized solutions for heartburn or whatever else is going on!

Julia Getzelman, M.D. founded GetzWell Personalized Pediatrics in San Francisco in 2008 with a passionate commitment to bring pediatric functional medicine to the Bay Area. She graduated with a Bachelor’s degree in Psychology from Stanford University with Distinction and Phi Beta Kappa and later earned her medical degree from Yale University and completed her residency at Children’s Hospital Oakland. Dr. Getzelman has extensive experience and expertise in successfully treating babies’ and children’s gastroesophageal reflux (heartburn) without pharmaceuticals.

Want to know more?

We are committed to providing the best pediatric care in the Bay Area. If you want to learn more about our practice, please contact us.