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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?
FDA Flip-Flops on Nitrosamines in Zantac and Ranitidine
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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