The People's Perspective on Medicine

The Zantac – Ranitidine Weirdness Just Got Stranger

What are we to make of FDA flip flop flips on ranitidine/Zantac? For many people the ranitidine weirdness is too much to take. But there are alternatives.
Recall stamp illustration isolated on white background.

If you have been reading this newsletter you know that one of the most popular acid-reducing drugs in the world has become embroiled in a carcinogen controversy. Several weeks ago a pharmacy in New Haven, Connecticut, Valisure, ran a routine test on ranitidine to check for nitrosamines. Here are links to the initial ranitidine weirdness:

Popular Heartburn Drug (Zantac/Ranitidine) Tainted with a Carcinogen

Followed by:

FDA Flip-Flops on Nitrosamines in Zantac and Ranitidine

Ranitidine Recalls?

With such ranitidine reports it is not surprising that readers might be a bit confused. This person wants to know about a ranitidine recall:

Q. I have been on ranitidine to control acid reflux for four years. Ranitidine has been in the news, but I cannot find out if my medicine has been recalled. It is made by Strides Pharma. My pharmacist has been no help. Do you have any info?

A. Strides Pharma Science Limited, based in Bangalore, India, stopped US sales of ranitidine in late September. Your pharmacist should have been able to check on this for you.

From the Horse’s Mouth:

We consulted David Light, head of Valisure, the Connecticut pharmacy that discovered the carcinogen NDMA in ranitidine (Zantac). He told us:

“Many, if not most, ranitidine products have now been recalled. It is the view of Valisure that the chemical, biological and clinical data strongly suggest that all ranitidine products are easily susceptible to forming the carcinogen NDMA. Valisure tested other medications in the same drug class, H2 blockers, that do not have the same inherent ability to form NDMA. These include famotidine (Pepcid) and cimetidine (Tagamet). It’s important to note that another H2 blocker, nizatidine, also formed NDMA in Valisure’s chemical tests.”

Listen to David Light describe in greater detail how Valisure discovered the nitrosamine problem with ranitidine and other options people with heartburn might have on last Saturday’s podcast. The Light interview occurs about two-thirds of the way into the podcast, after our discussion with Dr. Tieraona Low Dog about dietary supplements. Here is a link.

Another FDA Flip-Flop on Ranitidine:

This is what we call triple whiplash. First, the FDA said “some” ranitidine pills contained the nitrosamine impurity NDMA. That was on September 13, 2019. The agency was responding to a September 9, 2019 “Citizen Petition” from Valisure, the pharmacy that discovered the problem. The FDA downplayed the risk and did not call for individuals to stop taking ranitidine.

Second, the FDA did a U turn. The agency initially stated that the nitrosamines in Zantac and ranitidine “barely exceed amounts you might expect to find in common foods.” Then it stated that:

“To date, the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine.”

Many pharmaceutical companies announced voluntary recalls for ranitidine.

Third, on November 1, 2019 the FDA once again downplayed the danger of nitrosamines in ranitidine. Here is part of the statement from Dr. Janet Woodcock, the FDA executive who has tremendous authority at the agency:

“Through our testing so far, we have found levels of NDMA in ranitidine that are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats… Although many of these levels of NDMA observed through FDA testing are much lower than the levels some third-party scientists first claimed, some levels still exceed what the FDA considers acceptable for these medicines…. If we or the manufacturers find NDMA levels above the acceptable limits (96 nanograms per day or 0.32 ppm), we’re now asking companies to voluntarily recall ranitidine. We would also ask manufacturers to voluntarily recall nizatidine, commonly known as Axid, if they found NDMA above the acceptable daily intake level because it is chemically similar to ranitidine.”

Trying to Make Sense of Ranitidine Weirdness

Permit us to try to summarize the FDA’s position and a contrary assessment from David Light:

  • Yes, some, perhaps most, ranitidine products contain the nitrosamine N-nitrosodimethylamine (NDMA). It is a “probable carcinogen.”
  • Some of the ranitidine/Zantac the FDA tested had nine times the “acceptable limit” for NDMA.
  • Do not worry, though. Dr. Woodcock says “Through our testing so far, we have found levels of NDMA in ranitidine that are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats.” In other words, do not worry, be happy.
  • Some scientists have suggested that ranitidine can be converted to nitrosamines inside the human body because the chemical structure of the acid-suppressing drug is inherently unstable. The FDA responded: “We also conducted tests that simulate what happens to ranitidine after it has been exposed to acid in the stomach with a normal diet and results of these tests indicate that NDMA is not formed through this process.”
  • David Light of Valisure responds: “… these are overly simplistic conditions that do not properly evaluate a real-world stomach.”

Stanford researchers reported in the journal Carcinogenesis (June, 2016):

“In this work, we confirmed the production of N-nitrosodimethylamine (NDMA), a potent carcinogen, by nitrosation of ranitidine under stomach-relevant pH conditions in vitro. We also evaluated the urinary NDMA excretion attributable to ingestion of clinically used ranitidine doses. Urine samples collected from five female and five male, healthy adult volunteers over 24-h periods before and after consumption of 150mg ranitidine were analyzed for residual ranitidine, ranitidine metabolites, NDMA, total N-nitrosamines and dimethylamine. Following ranitidine intake, the urinary NDMA excreted over 24h increased 400-folds from 110 to 47 600ng, while total N-nitrosamines increased 5-folds.”

Our Bottom Line on Ranitidine Weirdness

The FDA says there are unacceptable levels of nitrosamines in ranitidine, but don’t worry, it’s really not a problem. We’re not sure the story is over. We suspect that the ranitidine weirdness will continue for weeks or even months. Stay tuned for updates.

In the meantime, our advice to this reader is:

Talk with your primary care provider about an alternative to ranitidine. You may wish to consult our Guide to Digestive Disorders for nondrug approaches to controlling heartburn. You can find it in our Health Guide section at this link.

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    About the Author
    Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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    Citations
    • Zeng, T. and Mitch, W. A., "Oral intake of ranitidine increases urinary excretion of N-nitrosodimethylamine," Carcinogenesis, June, 2016, DOI: 10.1093/carcin/bgw034
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    All these contradictions are driving me crazy! What is with the FDA?? When I got a refill for Ranitidine last week (which I’ve taken for years), the pharmacist told me the prescription med was fine–it was only the over-the-counter Ranitidine that was recalled! Please comment!

    Your pharmacist has not done her homework. Please check with another pharmacist.

    Readers might also be interested that in a 10/2/2019 update from the FDA, it indicated that the 3rd party lab used an unacceptable method of testing. I noticed that Valisure’s results showed extremely high levels of NDMA. Here’s a quote from the FDA:

    “FDA observed the testing method used by a third-party laboratory uses higher temperatures. The higher temperatures generated very high levels of NDMA from ranitidine products because of the test procedure. FDA published the method for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities. That method is not suitable for testing ranitidine because heating the sample generates NDMA.”

    It’s true that the FDA found “unacceptable” levels, but it makes me feel better that the extreme levels first reported by Valisure are likely not accurate.

    I have weened myself off of ranitidine anyway.

    Bob,

    It’s a bit more complicated than it seems. It is my understanding that Valisure used a testing procedure that was recommended by the FDA in its initial analysis. Then the FDA changed its testing procedures. You might want to see what Valisure has to say about the testing process.

    I received a recall notice from my druggist, but the thousands of pills I took in the past 6 or 7 years cannot be recalled out of my system! This is quite worrisome.

    Not everyone takes Ranitidine or Nizatidine for heartburn. I have cholinergic urticaria and the only thing that makes it manageable is an H1 and H2 antihistamine taken together. I was on ranitidine and was then switched to nizatidine. Apparently, just as bad. :-(

    I took Meds for GERD for 10 years. Finally I tried apple cider vinegar after my evening meal, although it seemed counterintuitive, it worked! That was 12 years ago. Initially I also took enzymes & drank a couple of ounces of George’s aloe vera for healing. I also sleep with my head raised. I use the things they sell to raise all 4 bed legs for under the bed storage, but only put them under the headboard feet.

    I’m so happy to be med free & not worry about all the side effects. Don’t go cold turkey with the meds, wean off gradually while implementing natural cures. Only about 10% of people really have too much acid. God made stomach acid for a reason, to digest our food. If we don’t properly digest we don’t absorb the nutrients.

    * Be nice, and don't over share. View comment policy^