In 2020, the Food and Drug Administration (“FDA”) pulled Zantac and ranitidine from the market after an investigation found the drug contained Nitrosodimethylamine (“NDMA”).
“NDMA is one of the most well characterized and most potent animal carcinogens known and has been shown to be a potent carcinogen across all species that have been investigated, both as single doses and with long term exposure to lower quantities.”
History Of Zantac
Zantac was first sold in 1983 by a predecessor to GlaxoSmithKline (“GSK”).
At that time, GSK was much smaller than other U.S. pharmaceutical companies. GSK had work to do if it wanted to win market share.
GSK launched an aggressive Zantac marketing campaign targeted at consumers and doctors. GSK’s “novel” marketing strategies included “public-service announcements, celebrity media tours, and consumer-awareness bulletins.”
GSK decided to “copromote” Zantac with French drug maker Hoffman LaRoche. This allowed Roche’s larger, established, and more formidable sales force to advertise to doctors.
Doctors liked Zantac because its main competitor, Tagamet, had to be taken four times per day. Zantac was twice-daily.
This meant Zantac had little “price elasticity”: GSK was able to charge as much as 25 percent more for Zantac than the going rate for Tagamet.
GSK’s advertising strategy included marketing not just to gastroenterologists, but also to primary care doctors. This greatly expanded the drug’s market. Zantac sales eclipsed $1 billion by 1986, accounting for 50 percent of GSK’s sales and profits.
In 1988, GSK further broadened the market through a “disease awareness” campaign that encouraged 500,000 people suffering from heartburn to visit their doctors.
In April 1996, Zantac was launched in over-the-counter form. GSK launched an ad campaign in which actor Brian Dennehey touted the “trusted” drug Zantac as the “final word on acid relief:”
More information regarding Zantac’s early marketing can be found in the 1996 article “How Zantac Became the Best-Selling Drug In History”, by Richard Wright, M.D. The article can be found here.
When Glaxo’s patent expired in 1997, other manufacturers got in on the action, including Boehringer Ingelheim, Pfizer, and Sanofi.
As our other articles detail, Zantac was pulled from the market in April 2020 due to the presence of NDMA, a probable human carcinogen.
What Is Zantac For?
Ranitidine has been used for a number of purposes, including to relieve heart burn, gastric and duodenal ulcers, peptic ulcers, acid reflux, gastroesphogeal reflux disease (“GERD”), and espophagitis.
Ranitidine was sold in tablet form including 75 mg, 150 mg, and 300 mg. In the United States, 75 mg and 150 mg doses were available over the counter.
How Zantac Works?
Zantac/ranitidine is an H2 (histamine) blocker.
Histamine is a naturally occurring chemical that encourages the stomach to produce acid. Ranitidine decreases stomach acid by blocking histamine.
What Is NDMA?
N-Nitrosodimethylamine (“NDMA”), also known as dimethylnitrosamine (“DMN”) is an organic compound with the formula (CH3)2NNO.
NDMA is, among other things, a byproduct of rocket fuel.
NDMA has been designated as a probable human carcinogen since the 1980s.
How Does NDMA Get Into Zantac/Ranitidine?
NDMA has been found to contaminate medication during manufacture, as a result of contaminated ingredients, or due to contaminated solvents and catalysts.
Recent studies have indicated, however, that the NDMA in ranitidine is from the breakdown of the drug itself.
In April 2020, the FDA announced it had “found N-nitrosodimethylamine (NDMA) levels in some ranitidine products increase with time and temperature posing a risk to consumer.”
In other words, the amount of NDMA in Zantac increases when it sits on the shelf, and also when the drug is exposed to higher temperatures.
How Much NDMA Is In Zantac/Ranitidine?
The FDA has testified that the acceptable daily intake of NDMA is 96 nanograms per day. A Stanford University study determined that Zantac/ranitidine users had over 40,000 nanograms of Ranitidine in their urine 24 hours after ingestion. That is more than 400 times the acceptable amount.
Further, most NDMA is absorbed in the body before it is excreted in urine. This would mean that the actual NDMA levels were much higher than 400 times the acceptable amount.
As the Stanford Study stated, “[a]ctual systemic NDMA exposure is likely much higher than that eliminated in urine, as previous studies have indicated a high metabolic conversion rate of NDMA (i.e. >99.9%) and therefore its low renal clearance (i.e. only ~0.05% excreted in urine).”
If the 40,000 grams of urine ranitidine is only .05% of amount in a person’s body, that would mean there could be as much as 80,000,000 (eighty million) grams of ranitidine the bodies of the persons in the Stanford Study.
That would be approximately 833,333 (eight hundred thirty three thousand, three hundred thirty-three) times the acceptable amount of NDMA.
In September 2019, analytical pharmacy Valisure filed a citizen petition to have ranitidine/Zantac pulled from the market.
In support, Valusre submitted an affidavit from gastroenterologist Dr. Jon Ernstoff which states ““Had I known of the NDMA risk associated with Zantac, I would have strongly considered prescribing alternative medications for the indicated conditions, such as another histamine blocker or a PPI. For the indicated conditions, there were always alternative treatments available with acceptable safety, cost, and efficacy profiles.”
The FDA ordered “a market withdrawal of all remaining prescription and OTC ranitidine products on the U.S. market “ in April 2020.
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