The People's Perspective on Medicine

FDA Flip-Flops on Nitrosamines in Zantac and Ranitidine

Another week another FDA announcement about nitrosamines in Zantac and ranitidine. The FDA makes a U-turn! Still no recall, though. What should you do?
Winneconne WI -25 Sept 2015: Box of Zantac anti acid indigestion medicine.

We warned you. The Zantac/ranitidine story is not over! Remember, just a few weeks ago we sent out a People’s Pharmacy Special Health Alert regarding unexpectedly high levels of the nitrosamines in Zantac and ranitidine. Valisure, the only pharmacy in the country that is testing pharmaceuticals for quality and purity, announced its discovery of a probable carcinogen in these popular heartburn remedies. 

Valisure asked the FDA to “recall and suspend sale of all lots of all products containing ranitidine.” That was because Valisure reported that levels of NDMA that were way higher than permitted by the Food and Drug Administration.

The FDA Initial Response:

Predictably, the FDA downplayed the danger. On September 13, 2019, Dr. Janet Woodcock, an executive at the pinnacle of the FDA’s drug oversight program offered this comment

“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.

“Patients should be able to trust that their medicines are as safe as they can be and that the benefits of taking them outweigh any risk to their health. 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 Latest FDA Response About Nitrosamines in Zantac and Ranitidine:

In an about face, the FDA announced this week that: 

“FDA will test ranitidine oral solution products and has begun testing samples of other H2 blockers and proton-pump inhibitors to help inform this ongoing investigation. To date, the agency’s early, limited testing has found unacceptable levels of NDMA in samples of ranitidine. The agency will provide more information as it becomes available.”

Please note the U turn. The FDA went from nitrosamines in Zantac and ranitidine “barely exceed amounts you might expect to find in common foods,” to “unacceptable levels of NDMA in samples of ranitidine.” 

What should people do?

As far as we can tell, the FDA has not yet recalled ranitidine products. It has resisted the kind of regulatory action that has been taken in countries like Germany, France, Italy, Taiwan, Austria, Switzerland and Canada. 

Normally, U.S. pharmacies wait for the FDA to announce a recall before they take independent action. Not so now. In the case of nitrosamines in Zantac and ranitidine retailers are way out in from of the Food and Drug Administration. CVS, Walgreens, Rite-Aid and Walmart have withdrawn both the brand and generic forms of ranitidine. 

We suspect that this story is not yet over. Eventually, the FDA is likely to have to take some action. Why it has become a follower instead of a leader puzzles us. 

Readers Comment:

Here are some thoughts from readers of our People’s Pharmacy Special Health Alert:

C.B. shares this confusion:

“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 company 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.”

Mike responded to our People’s Pharmacy Special Health Alert this way:

“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.

“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.”

The head of Valisure responded to our query about this very concern. He said that their testing has been verified by a third party.

Sharon offers this perspective:

“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 my husband pause and he is calling his doctor to discuss switching to Tagamet/cimetidine.”

What Do You Think?

Please share your own thoughts about nitrosamines in Zantac and ranitidine 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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    What alternatives are available OTC? PP articles have long warned about proton-pump inhibitors. Is Pepcid-AC in the same class as Zantac?

    It is in the same class. However, it is not clear that it too contains high levels of nitrosamine.

    I have been taking prescription Ranitidine for about four months. I called my gastroenterologist’s office, and the nurse told me to stop taking the Ranitidine and take over the counter Pepcid AC, 20 mg. So that is what I am doing. I have an appointment with her at the end of the month and will be anxious to see what she says.

    I had a blood test on September 4th. They asked me to come back in on September 17th because the first one showed my potassium was high. The blood test on the 17th showed my potassium was OK but my creatine level had jumped from .93 to 1.43. The only thing different was the 10 Equate 150 mg. Ranitidine I had taken (cool mint). I read your article on the 16th and immediately stopped taking that medication. I am now waiting to see what the last blood test taken October 1st will show.

    The article on “Herbal Medicines Lower Blood Pressure” appearing in this edition has encouraged me to try this approach for GERD too. Of course, will check with my doc, but she supports the use of herbal therapy. May be a way to reduce the number of pills each day. Certainly worth a try. The brand of essential oils I use is a high quality brand and not inexpensive, be sure to check it out.

    I think they need to limit or stop funding the FDA through contributions from Big Pharma. It’s such an obvious conflict of interest. It’s like if the ATF got its funding from weapons manufacturers. Sorry I’m not getting political…that’s NOT my point at all. But with the case of FDA, it receives funding from the very groups and corporations that it is supposed to be regulating. Very strange imo.

    I have no faith in government oversight. I returned two unopened bottles (of course I stocked up on that) and will use another product. Of course, the concern is that there will be an issue again with something else.

    This is informative. I have taken Zantac for
    More than 30 years. I also take a Prevacid daily.
    I’m continuing my medicine unless my dr says to stop. Next thing we will hear is that it is ok. Hard to determine what to do.

    Whenever I read about one company recall I know there will be more coming. I am very surprised that so many stores took them off the shelves. Perhaps they are concerned people will sue.

    The blood pressure pill recall is another prime example.

    What boggles my mind is the nonchalant attitude of pharmacists and doctors. If we take these medications for long periods of time we have no idea if these trigger the cancers that we might get. When I spoke to my husband’s cardiologist about his Losartan, he replied there is no way that anyone can determine that the tiny amount of carcinogens in these pills can be the cause of cancer so just continue taking them. These are the answers we get when questioned.

    I just wonder how many drugs have bad things in them! It’s quite scary.

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