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.
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.”