The People's Perspective on Medicine

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

Is ranitidine (Zantac) tainted with a carcinogen called NDMA? Should it be recalled? The FDA says NDMA is in ranitidine, but no worries. We're not so sure.

On Friday, September 13, 2019, the FDA officially acknowledged that “some” ranitidine (Zantac) pills have been found to contain the nitrosamine impurity NDMA (N-nitrosodimethylamine). Nitrosamines are considered potent carcinogens. How did this happen? How long has it been going on? Who discovered this problem? How worrisome is it? What should be done? This People’s Pharmacy Special Health Alert will attempt to answer those questions.

The Snowball That Started the Avalanche:

You may remember that the popular blood pressure drugs called ARBs (Angiotensin II Receptor Blockers) started being recalled over a year ago because of carcinogen contamination. Drugs like irbesartan, losartan and valsartan were found to contain nitrosamines such as NDMA, NDEA (N-nitrosodiethylamine) and NMBA (N-nitroso-N-methyl-4-aminobutyric acid).

We were among the first to notify the public about this disaster. We issued a People’s Pharmacy Health Alert on July 15, 2018, about the blood pressure medicine Valsartan (Diovan).  That was 10 days after the European Medicines Agency raised the first red flag about Chinese-made valsartan contaminated with NDMA. We had to keep revising this article as more recalls followed.

Since then we have written about “sartan” recalls so many times we have lost count. Tens of millions of pills have been pulled off pharmacy shelves because of nitrosamine contamination. Here is just one of our many posts:

Another Day Another Losartan Recall | Can We Trust the FDA?

Who Discovered that Ranitidine Is Tainted with a Carcinogen?

Because of concerns about generic drugs in general, and the ARB contamination catastrophe in particular, one pharmacy decided to start testing all the drugs it dispensed. Valisure is an online pharmacy based in New Haven, Connecticut. 

The company’s motto:

“Valisure is the only pharmacy that chemically tests every batch of every medication that we sell, at no additional cost.

“Batch-tested medication. Delivered to your door.”

The scientists at Valisure discovered that the ranitidine and Zantac samples it was testing had unexpectedly high levels of the nitrosamine NDMA. This is an extremely popular acid-blocking drug. According to our calculations, over 15 million ranitidine prescriptions are dispensed annually. That does not count all the over-the-counter bottles of Zantac and house brand ranitidine that are sold.

Zantac was first marketed in the U.S. in 1981. By 1987 it was the # 1 most prescribed drug in the world. An executive at GlaxoSmithKline was purported to have said that “Zantac was the engine that pulled the train.” In other words, Zantac was the cash cow at the company.

Valisure’s Citizen Petition on Ranitidine:

On September 9, 2019, Valisure notified the Food and Drug Administration that there was a big problem with ranitidine and Zantac.

That was when it filed a “Citizen Petition” with some startling revelations:

“The drug ranitidine, commonly sold under the brand Zantac, is an antacid, specifically an H2 receptor blocker (“H2 blocker”), which, due to a very high perception of safety, is heavily prescribed to adults and infants and sold over-the-counter. Valisure tests all batches of all its medications for quality and consistency issues and through such tests detected extremely high levels of N-nitrosodimethylamine (“NDMA”), a probable human carcinogen, in every lot tested, across multiple manufacturers and dosage forms of the drug ranitidine. The Food and Drug Administration (“FDA”) has established a permissible daily intake limit for the probable human carcinogen, NDMA, of 96 ng. Valisure has detected NDMA in excess of 3,000,000 ng per tablet when analyzing ranitidine products, likely due to an inherent instability of the ranitidine molecule.”

Yikes! Do the math. If Valisure’s testing procedures are accurate, that’s over 30,000 times the permissible FDA level for NDMA. Valisure calls for the agency to “recall and suspend sale of all lots of all products containing ranitidine.” The pharmacy asks the FDA to investigate the manufacturing processes for this drug and instruct people on the safe disposal of ranitidine.

FDA’s Response:

The initial response from the FDA was surprisingly prompt. On September 13, 2019, Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research (CDER) put out a statement.

It said in part: 

“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.

“The FDA has been investigating NDMA and other nitrosamine impurities in blood pressure and heart failure medicines called Angiotensin II Receptor Blockers (ARBs) since last year. In the case of ARBs, the FDA has recommended numerous recalls as it discovered unacceptable levels of nitrosamines.

“When the agency identifies a problem, it takes appropriate action quickly to protect patients. The FDA is evaluating whether the low levels of NDMA in ranitidine pose a risk to patients. FDA will post that information when it is available.

“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.

“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.”

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Unanswered Questions About Ranitidine Tainted with a Carcinogen:

  • How long has this been going on?

We may never know for sure. According to Valisure, nitrosamine formation may be an inherent characteristic of the ranitidine. That means it could have existed for decades.

  • How worrisome is the NDMA in ranitidine and Zantac?

Valisure seems to believe that this is so serious all products containing this molecule should be recalled now. The FDA seems to be saying, don’t worry, be happy. The agency is not calling for a recall and “is not calling for individuals to stop taking ranitidine at this time…”

  •  What should be done?

We need immediate assessment of the level of risk. Is the amount of nitrosamine contamination as minimal as the FDA suggests or as alarming as Valisure contends?

David Light, CEO of Valisure, is quoted as saying (Bloomberg, September 13, 2019): 

“There’s no acceptable cancer risk for a drug like this.”

Until all questions are answered, we tend to err on the side of caution. There are lots of antacids and acid-controlling drugs on the market. H2 antagonists like cimetidine (Tagamet) and famotidine (Pepcid) have not been linked to nitrosamines. Good old-fashioned baking soda (sodium bicarbonate) can serve as an antacid in a pinch. And of course there are products containing calcium carbonate or magnesium hydroxide. These ingredients are found in OTC antacids.

You can read about lots of ways to control indigestion in our eGuide to Digestive Disorders.  If you prefer nondrug approaches to heartburn, you will find lots in The People’s Pharmacy Quick & Handy Home Remedy Book

Final Words:

We used to be among the FDA’s biggest boosters.

In our second book, The People’s Pharmacy-2 (1980), we acknowledged an FDA Commissioner:

“A great many people helped us put this book together. We never could have made it without the assistance of…

“Jere Goyan, the best damn Commissioner of the Food and Drug Administration this country has ever had!”

There are many great scientists at the Food and Drug Administration. That said, we have lost confidence in the agency. Its ability to monitor generic drug quality and safety has been called into questions. You can listen to our free interview with Katherine Eban about her book, Bottle of Lies at this link.  Our interview with Rosemary Gibson, author of China Rx: Exposing the Risks of America’s Dependence on China for Medicine can be found here

Should you wish to learn more about how we discovered flaws in the FDA’s oversight of generic drugs, here is a link to Top Screwups. 

What do you think about the possibility that ranitidine is tainted with a carcinogen? Is it all a tempest in a teapot? Only time will tell. Please share your thoughts in the comment section below.

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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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To add further confusion for us consumers, I asked my local non-chain pharmacist about my ranitidine Rx, and she said that they don’t buy from the same pharma that produced the batches tested by Valisure so their’s was OK. I asked if their batches had been tested, and she said ‘No’. So what do I as a consumer do? No choice but stop using it. I asked for an alternative, and she said to see my doctor.

How is the carcinogen introduced into the ranitidine? Is it in something that all pharma sources from the same place?

Ranitidine is also said to cross-react in the so-called Jaffe chemical assay for creatinine, giving erroneously high levels. Whether this is due to ranitidine itself or breakdown substances such as nitrosamines, I have not been able to determine. The presence of normal blood levels of blood urea nitrogen (BUN) and/or cystatin-C with high levels of Jaffe-reacting substances in blood is indicative of a falsely elevated estimated glomerular filtration rate (eGFR), used clinically to indicate “renal disease” and possibly the “need” to treat it.

This is probably not as dangerous as the cancer risk but is another reason not to take ranitidine.

Thank you. I saw the FDA announcement but knew you’d have better info. I’ve been taking 150 mg twice a day for about a year and a half. I take it mainly for a painful bladder condition, though it also helps my GERD. I may try going off it and see if I get flare ups. Another good product is Prelief, which I also take for the bladder condition. It’s calcium glycerophosphate. Maybe if I double up on it that will work. It’s fairly low-dose calcium and phosphorus.

This is stunning. I do everything I can to keep myself healthy. Now to find out I’ve been taking poison pills twice a day. Would like to know for certain if Famotidine has the same problem.

We have not seen analyses of famotidine showing this problem.

Here’s a note from a member of a listserve where I forwarded the link to this article:

My husband is a clinical biochemist who owns an analytical lab and previously worked in drug development. He read this piece and his first remark was that, if he were doing this analysis, he would check the instruments. He feels the amount of NDMA shown here is practically unbelievable, particularly for a tablet of 150 mg. This would make NDMA 2% of the active ingredient(s) in the tablet. While he is no Susie Sunshine when it comes to today’s drug world, and certainly this is not *completely* impossible, he says it pays to be skeptical when faced with numbers like this.

Do we have any idea how far back this may go? I have a bottle of the generic form that dates back to 2016, as I take the meds only occasionally. Should I throw it out?

This whole thing is yet another scare tactic article. The risks are for long term use. The chemical is only a “probable” carcinogen. The studies are animal studies. The criteria for being named this is a very low bar, and is not peer reviewed. We don’t know the number of pills they tested, 4, 10, 400? Or how many batches they came from or for how long. The internet has become a place for science scaremongers to gin up clients for class action lawyers. Look for the mass saturation ad campaigns soon.

What’s wrong with taking calcium carbonate (a couple of Tums) or sodium bicarbonate (a pinch of baking soda) ??

By my math, it looks like 2% of ranitidine by weight is actually nitrosamine. This is more than trace contamination, 3mg of nitrosamine can be gotten from grilled foods, certainly. But ranitidine is taken every day. There is no reason for that much nitrsamine to be present.

Acupuncture has solved 95% of my heartburn issues with a corresponding decrease in the use of any medications or other treatments.

I used to have trust in the FDA. What has happened?

Thank you again for keeping us informed.

As you suggest cimetidine and famotidine are similar drugs and the switch should be easy. I take famotidine occasionally; it works very well and does not have the side effects of the powerful PPI drugs

Been taking generic, sugar free cool mint tablets, Equate ranitidine for a while. Looking on label, I do not see ingredients listed. How can one be sure that NDMA is or is not in this brand and to what level, or is NDMA a standard ingredient in all ranitidine?

Is Zantac manufactured in China?

You say: ” 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.”

I agree, but what should we be looking for?

I don’t trust any federal government agency now. With deregulation and harassment of scientists by the current administration, we consumers are left without any reliable help. I already switched to Pepsid.

Very disturbing and eye opening article.

Has Valisure sent the tested medications out to 3rd party labs to verify their findings? Doing so would add validity to their findings and is something the non profit group Consumer Labs does when it tests supplements.

At any rate we need more pharmacies to do this type of testing as it appears we can’t always count on Federal agencies,like the FDA, to do what is in the public’s best interest.

We need to stop having these drugs manufactured in China. I think we should be able see on the bottle where the drugs are manufactured. Let the people decide. Personally, I always prefer to buy American made products.

FDA should be in an adversarial relationship with the companies that it is in charge of investigating. Instead the opposite is true.

My husband has been taking Zantac for decades to control his heartburn. Unfortunately, he swallowed the FDA’s statement about the recently detected contamination hook line and sinker. We live in a senior retirement community and many of our friends share his viewpoint: the FDA is infallible, never to be questioned.

I, on the other hand, am a retired nurse and have learned through years of personal experience that the FDA pronouncements are to be taken with a grain of salt. This didn’t use to be true… The FDA initially was a trustworthy institution. I believe they are overwhelmed by the sheer numbers of generic drugs on the market. Is this due to a lack of money or staffing? I would certainly consider the funding of this organization to be a top priority because it affects the health of so many Americans!

Fortunately your timely article has given him pause and he is calling his doctor to discuss switching to Tagemet/Cimetadine.

It BLOWS ME AWAY THAT TOXIC CHEMICALS ARE IN SO MANY PRESCRIPTIONS, FOOD, DRINKS AND OTC MEDS! What happened to natural? Why the need for everything to contain such destructive ingredients??? I know the answer but you’ll need to do the research. I want my comment to be published and if I told the reason, my comment might get put aside. I hope and pray people will wake up and start taking control of their health better. This is a all out war by the elite, to cull the populations. The FDA is very corrupt and is paid millions by the pharmaceutical companies to approve all these toxic meds. It’s a crime and it needs to be stopped!! Thank you People’s Pharmacy for all you do!! Thank you for helping all of us out with your VERY INFORMATIVE and truthful articles.

The FDA has become the front man for Big Pharma, protect, protect, protect Big Pharma profits, no matter the health concerns of the people.
I am 63, no prescription or over the counter meds for me, except aspirin a few times a year. I control health issues with diet and exercise. Started Keto lifestyle again in May, 2019, because of weight gain and high blood pressure. Weight got up to 275 and blood pressure was 140/90. Weight is now 236 and dropping every week. Blood Pressure is now 117/70. I will never go back to a high carb diet. 50 grams of carbs max per day, for the rest of my life.

The saying, “ When in doubt, don’t” should apply here. Why take a medicine which could do harm?

Might this end up being a wider recall like Losartan, then Valsartan, and other “sartan” drugs etc. etc.?
Who is to say that in a few weeks or months this recall won’t include other “dine”-ending heartburn drugs such as cimetidine and famotidine??

Joe, the FDA is not denying NDMA is in ranitidine. They are probably gathering and testing multiple batches from multiple vendors and sources to discover the scope of the problem. They can then make a complete announcement, avoiding trickle-out, cascading announcements, for which you have castigated them.

You cannot have it both ways. All the companies at once, or one at a time, which do you want?

After seeing the 60 minutes expose on generic drugs and reading the many articles that have been published I feel we are in crisis. We can no longer depend on generic drugs as we did before when most were made in the USA and Europe. The FDA has lost control of the situation and l can no longer protect the American public.

Always better to err on the side of caution. The FDA must learn to respond and test more quickly.

Conservative politicians, the ones who support big business and the people be damned, are responsible for this demise. Vote, vote, vote, people.

Thanks for your attention to the medication contamination crisis. I am curious as to why we have so many international pharmaceuticals sending med to the US. So, I checked out the contamination, I ask the pharmacist about a recall. He told me his pharmacy does not stock the tainted drug manufacturers listed in the complaints. Indicating safety, right. Then, asked our internist, she said there really is no alternative to losartan. Now, that does not make me feel safe.

I will get the digestive book. My mother had digestive problems and she used baking soda. I was scripted omerprazole for silent reflux, which caused sore throat and voice issues.

Thanks for the guidance and attention to public health.

This is extremely concerning to me. I have been on Rx ranitidine and propanazole since 2017- when I very nearly died from a bleeding ulcer ( by the time I was admitted to hospital, my hemoglobin was slightly less than 3.5 – this is not a misprint). My gastro said I would be on it for the rest of my life. I have completely changed as many factors in my life as possible to reduce stress, eat plant-based diet, no NSAIDS of any type, and no alcohol. One side effect I was aware of is that the medications seriously depletes my Vitamin D levels. This possibility I was not. I will be calling the doc this week for sure. Thank you for all you do to keep us aware!!!

Can we trust the FDA? Not for my health dollar. As far as acid-blocker drugs, I did it myself. I examined the possible causes of my acid reflux and got off the drugs all together. My doctor was not much help.This was likely a do-it-yourself-project. There are resources online to assist you as well as books on the subject. I did it, so I know it might be possible for many.

This is distressing: I have been taking prescription Ranitidine for several years. Considering discontinuing and seeing if bicarbonate of soda would do enough–but I think I read baking soda has has high sodium levels, and thus creates yet another problem. Thanks for telling us about this issue.

How can the FDA set an “acceptable” level for these “probable carcinogens”, (in itself a contradiction, considering no level of a carcinogen is safe, theoretically 1 molecule could trigger cancer), then basically blow off a report of 30,000 times higher levels with the flippant rationalization that it is barely higher than levels found in some foods? That’s supposedly fine if you aren’t eating those foods and taking ranitidine at the same time. You can’t act like the ranitidine is the sole risk. What about the other carcinogens we all are exposed to unknowingly every day, and knowingly, including UV radiation ? No sane person can expect to have zero exposure, but we certainly can expect protection from known, and unnecessary sources.

Personally, my opinion of the FDA has diminished significantly over the last couple of years, more proof government agencies cannot be depended on to do a better job than independent private entities. This is big news, and I think the agency is always playing catch up and doesn’t like being shown up. Medications all have risks involved, so there should always be consideration given to risk vs benefit. There is no benefit to carcinogens, especially when good alternatives exist to the drug in question.

My son has been taking ranitidine most of his life due to GERD. This is very alarming. I will be looking at other options ASAP. This truly raises concerns about all our medications.

Now China can use medicine contamination against us? What’s next? We need to rethink our position of getting medicines manufactured in other countries. Make them in the USA. We need absolute control over the medicine manufacturing process.

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