Zantac – Buyer Beware, but from Whom?

December 9, 2019, 2:45PM. By Jane Mundy

Would Zantac consumers and retailers know about the link between Zantac and cancer if not for a small pharmacy – and subsequent Zantac lawsuits?

Santa Clara, CASince the small pharmacy Valisure waved the red flag over Zantac cancer risk, over 40 countries worldwide have stopped sales and/or began investigating the possible health risks of the heartburn drug. And Zantac lawsuits have followed. Now the FDA says it is “investigating”.

Zantac Cancer Lawsuit

Zantac complaints want to make it clear that they have nothing to do with contamination---this is not a manufacturing error. Rather, the “unacceptably” high levels of NDMA that researchers now see occurs as a function of the ranitidine molecule breaking down in the digestive system. If Zantac hasn’t changed its recipe, these levels of NDMA have been present in the heartburn drug since its approval for prescription use by the FDA in 1983.

One recent complaint was filed (November 19) by a woman who was diagnosed with stomach cancer in 2012. Mary Anthony says she regularly used Zantac since 1992 and continued to use it after her diagnosis, up until she learned about the Zantac cancer link in September of this year when Valisure pharmacy detected levels of NDMA that far exceeded the FDA’s daily limit of exposure to the chemical. Anthony was taking Zantac when the manufacturers and distributors for the drug also knew the increased risk of cancer due to its levels of NDMA, according to her lawsuit.

While Zantac lawsuits have been filed by individuals diagnosed with stomach cancer, bladder cancer, esophageal cancer, colorectal cancer and other cancers involving the digestive tract, they all have commonalities: all allege the makers knew ranitidine contained in Zantac breaks down into NDMA inside the body yet chose to keep this information from the public.
 

What is NDMA good for?

Absolutely nothing, according to Anthony’s lawsuit, which states that NDMA “used to be a chemical byproduct from the making of rocket fuel in the early 1900s but, today, its only use is to induce tumors in animals as part of laboratory experiments. Its only function is to cause cancer.” (A Zantac lawsuit  filed by plaintiff Walter Hansen noted that a news article from 1979 reported that “NDMA has caused cancer in nearly every laboratory animal tested so far.”)
 

What has the FDA done?

Besides establishing an acceptable limit for NDMA at 96 nanograms a day (a Zantac tablet contains 29,000 times that amount) the FDA hasn’t done much to calm some stomachs. Although the agency issued a warning in October that led to the voluntary U.S. and Canada recall by Sanofi and other companies that manufacturer generic versions of over-the-counter Zantac (ranitidine), not all pharmacies got the memo.

An FDA Update (12/4/2019) states the agency has launched an investigation after communicating (in other words, the agency was tipped off by the pharmacy) about the “detection of an impurity known as N-nitrosodimethylamin (NDMA) in common heartburn medications (ranitidine, commonly known as Zantac, and nizatidine) available over the counter or by prescription.” And it has asked manufacturers to conduct their own laboratory testing – in other words, to police themselves. In September 2019, in response to a citizen’s petition filed by the Valisure pharmacy, U.S. and European regulators stated that they are reviewing the safety of ranitidine.

The FDA update goes on: “Our scientists have determined ranitidine does not form NDMA in typical stomach conditions.” But what is typical? After taking Zantac since 1992, does Mary Anthony have a typical stomach?
 

Why is Zantac still Available?

Suzanne Jacobson, head of consumer healthcare and spokesperson for Sanofi, told SurivorNet that the responsibility of recall notification is up to the wholesalers that sold the product. “This recall is being taken due to possible contamination with a nitrosamine impurity called N-nitrosodimethylamine (NDMA). The company is working with health authorities to determine the level and extent of the recall,” said Jacobson.

According to the National Association of Wholesaler-Distributors, however, “the law authorizes the CPSC to order the manufacturer or any wholesaler-distributor or other seller of the product to give public notice of the defect and also give specific notice to every person to whom the product was delivered or sold. In addition to notification, the CPSC may order the manufacturer or any wholesaler-distributor or other seller of the product to either: (1) repair the defect in the product; (2) replace the product with an equivalent product free of defects; or (3) refund an amount up to the purchase price of the product.”
 

Zantac Cancer Risk Facts

• Ranitidine is sold under various names by various companies, such as “Wal-Zan” sold by Walgreens.
• Zantac is an H2blocker drug, which works by helping the stomach produce less acid. Other medications, such as Pepcid and Tagamet, work the same way and do not contain NDMA.
• NDMA has been classified as a probable carcinogen, but to date scientific evidence shows that the chemical causes cancer in animals. No human testing has been conducted.
• Trace amounts of NDMA are also found in water and certain foods, such as grilled meat.
• Consumers who wish to continue taking heartburn drugs should consider limiting their intake of nitrite-containing foods, e.g. processed meats and preservatives like sodium nitrite.
• Health experts advise alternative ways to avoid heartburn: don’t eat late at night as acid in a full and undigested stomach is more likely to reflux into the esophagus. Drinking less soda and alcohol can also help avoid heartburn.

Zantac’s Popularity

Reuters reported that in 1988 Zantac became the world’s best selling drug and one of the first-ever drugs to top $1 billion in annual sales. This was mostly due to GlaxoSmithKline’s marketing strategy that allowed the medication to dominate the acid/peptic marketplace, and Zantac became available over-the-counter in 1996.