On September 13 of this year Valisure, an online pharmacy, submitted a Citizen Petition to the FDA and urged it to pull all ranitidine (brand name Zantac) from the market. Ranitidine, an H-2 blocker, is widely utilized both by prescription and over the counter for gastric acid suppression in the treatment of acid reflux and peptic ulcer disease.
According to CEO, David Light, based on Valisure’s testing and review of the scientific literature, ranitidine is an inherently unstable molecule which degrades directly and with high efficiency to the known carcinogen N-nitrosodimethylamine (NDMA).
The FDA issued a notice that same day “alerting patients and health care professionals that NDMA had been found in samples of ranitidine.” but did not call “for individuals to stop taking ranitidine at this time” stating:
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.
By September 17, Health Canada asked companies to stop distributing the drug and at this time 30 countries have stopped sales of the drug. The FDA has yet to tell Americans not to take the drug indicating that it is awaiting more definitive studies.
In the meantime all major drug store chains and Amazon have voluntarily removed the drug from their shelves.
After listening to interviews with David Light of Valisure I’m convinced that everyone should stop taking ranitidine in any form because:
- The NDMA is not a contaminant but a breakdown product of an unstable ranitidine molecule and will be present regardless of which company makes it.
- NDMA is a highly significant carcinogen. Although not proven to cause cancer in humans it very reliable at causing it in mice. The levels Valisure detected are way above the levels the FDA considers acceptable.
Fortunately, there are many alternatives to ranitidine for acid suppression including PPIs (prilosec/omeprazole, pantoprazole, etc.) and an H2 receptor antagonist which does not have NDMA problems, famotidine.
Famotidine , according to this review:
is approximately 7.5 times more potent than ranitidine and 20 times more potent than cimetidine on an equimolar basis. Therapeutic trials indicate that famotidine 20 mg b.i.d. or 40 mg at bedtime is as effective as standard doses of cimetidine and ranitidine for healing duodenal ulcers. A dose of 40 mg at bedtime appears to heal benign gastric ulcers.
Skeptically Yours,
-ACP
N.B. I recommend this Peter Attia podcast interview with David Light (#75 – David Light: Zantac recall due to cancer concerns – what you need to know) if you want more details on Valisure and NDMA.
Also, check out Valisure’s description of the NDMA problem here.
Valisure is a unique pharmacy which per its website:
“sells the same meds that all American pharmacies use, but first put the batches through rigorous chemical analysis so the bad batches are screened out. We summarize our analytics in an easy-to-understand certificate of analysis specific to that batch. We are the only pharmacy to do this.”
10 thoughts on “You Should Stop Taking Zantac (Ranitidine) Now”
I should have included a link to the “FDA’s Assessment of Currently Marketed ARB Drug Products”:
https://www.fda.gov/drugs/drug-safety-and-availability/fdas-assessment-currently-marketed-arb-drug-products
Thank you Dr. P. That is helpful to know about the manufacturing process. I am keeping an eye on irbesartan on the FDA website. As far as I can tell all those which have not been recalled are on the “To Be Determined” (TBD) status, which is less than reassuring.
From the website:
An indication of “TBD” means that one or more parts of our assessment remain incomplete and the product remains acceptable for distribution and for patient use. For the entries denoted with “TBD*,” certain lots of the product did have impurity levels above interim acceptable limits, however they have already been removed from the market.
She,
Thanks for that info. Be sure to update us if more info on irbesartan emerges.
What about the sartans such as irbesartan?
Different problem causing NDMA contamination with the sartans so some manufacturers may be OK others not.
I’ve had moderate to severe GERD forever. At one point while I was married and working not even 300 mg of Zantac twice a day controlled it very well; I was waking up most afternoons (working 12-hr night shifts) with a sore, reddened throat and sometimes visible acid burns plus a really disgusting deposit on my teeth. Any proton pump inhibitor (Nexium etc) caused more pain than the acid (allergy?). Will resume using famotidine and maybe might just get some relief.
The science presented here that Zantac causes cancer is as reliable and valid as the science that proves coffee is carcinogenic. Years ago when taking an advanced class in Experimental Statistics our professor gave us a coffee study to analyze. The just of the study was that coffee caused pancreatic cancer in humans. Only thing is the study was garbage as there was no control for contributing factors such as smoking, age, sex, obesity ect. and it was a correlational study. Unless the skeptical doctor can present valid and reliable studies, at least 10 or more would be best, then what he is saying is his opinion and the opinion of a few other mostly worthless studies. Until then I will continue to drink my 3 cups of brew a day. As for Zantac. I don’t take any medications at 73 years and 8 months of age. None!!! By the way Doc how many PhD level classes have you completed in experimental design? How about just 1 year graduate courses? Granted you are a first class Cardiologist. If in doubt take the studies you mentioned to the applied statistics department of the nearest university.
Is there anything to the notion that reduced acidity of stomach acid – which often happens with aging – tends to relax the lower esophageal sphincter causing that weaker acid to leak, and that moderately increasing acidity to normal stimulates that sphincter to tighten, thereby easing reflux?
I was going to switch to famotidine but my drug interaction checker says it causes QTc issues when combined with my Paxil, whereas it doesn’t say that for ranitidine.
For the time being I am using Tums, which don’t seem as effective.
I have never tried a PPI. I had been advised against them but can’t remember why now.
Not long ago, we were told that PPIs cause side effects like kidney damage and osteoporitic hip fractures so we should switch to H2 blockers like ranitidine. Now they say ranitidine is carcinogenic and we should switch to PPIs. Famotidine is also recommended, but I wonder how long it will be before it’s found to have some terrible side effect.