Zantac Ingredients - Legal Claims for Cancer Caused by NDMA

Updated

The Zantac ingredient ranitidine likely causes cancer in people. Evidence shows ranitidine metabolizes in the body to create the compound NDMA, which scientists use to cause cancer in lab animals. The FDA requested that all products containing the ingredient ranitidine be recalled. And Zantac users who developed cancer are now suing the drug makers for large settlements.

In this article, our Zantac attorneys discuss:

Packaging for Zantac, which may cause cancer in people.
Ranitidine is the active ingredient of Zantac.

1. What are Zantac's active ingredients?

The active ingredient in Zantac is ranitidine hydrochloride. There is a strong possible link between ranitidine and developing cancer.1

2. What are Zantac's inactive ingredients?

The inactive ("filler") ingredients in ranitidine depend on whether the medicine is dispensed as a tablet, capsule, or syrup. It does not matter whether the drug is prescribed or OTC (over the counter). Or whether it is brand name (Zantac) or generic (ranitidine).

Inactive ingredients in Zantac (ranitidine)

Tablet

(75 mg, 150 mg, 300 mg)

Capsule

(150 mg and 300 mg)

Syrup

(Oral Solution, 15 mg/mL)

Hypromellose

Magnesium

Stearate

Microcrystalline cellulose

Synthetic red iron oxide

Titanium dioxide

Triacetin

Magnesium stearate

Microcrystalline cellulose

Sodium starch glycolate

Capsule:

FD&C blue 1

FD&C red 40

FD&C yellow 6

Gelatin

Titanium dioxide

Sodium lauryl sulfate

Capsule Edible Ink:

Black iron oxide

Potassium hydroxide

Propylene glycol

Shellac

Strong ammonia solution

Butylparaben

Sodium phosphate, dibasic

Hypromelloses

Sodium phosphate, monobasic

Peppermint

Propylene glycol

Propylparaben

Water

Saccharin sodium

Sodium chloride

Sorbitol

There is currently no evidence that these inactive ingredients cause cancer.

3. Does ranitidine cause cancer?

There is substantial evidence that Zantac and its generic ranitidine cause cancer in people.

The FDA claims many ranitidine products contain "unacceptable levels" of NDMA. This is a chemical compound, short for N-Nitrosodimethylamine.2

The FDA already acknowledges that NDMA causes cancer in animals. Researchers use NDMA to make lab rats develop cancer.3

The EPA has called NDMA  a "probable human carcinogen."7 And the U.S. Department of Health and Human Services also admits that NDMA is "reasonably anticipated" to cause cancer in people.8 For decades, people used NDMA to poison people to death:

  • In 1978, a husband put NDMA in his wife's jam. She died from liver failure.9
  • In 1978, a Nebraska man spiked a drink with NDMA. Two deaths resulted.10
  • In 2013, a student spiked the dorm water cooler with NDMA. His roommate died from it.11

The FDA has stated that consuming .096 micrograms of NDMA a day is "reasonably safe." Yet according to the FDA, several ranitidine lots contain 2.5 to 3 million nanograms in a single dose.12 This is 26,000 to 31,000 times more than the safe daily maximum.13 Studies also reveal that the urine of Zantac users contains a 400-fold increase of NDMA.14

The typical Zantac user took multiple doses over a long period of time. Often years if not decades. So is a logical conclusion that their NDMA intake may have caused their cancer.

3.1. Impurity versus byproduct

The FDA claims NDMA is an impurity in ranitidine. It said,

This is something we are thoroughly aware of, and we have ongoing assessment, surveillance, compliance and pharmaceutical quality efforts across every product area to work to ensure similar impurities can be kept out of our drug supply.15

The online pharmacy Valisure has a different stance. It believes NDMA is a byproduct. When a person ingests Zantac, the body causes it to create NDMA as part of the digestive process.

The FDA believes that Valisure's tactics of simulating human digestion were exaggerated. Valisure exposed the ranitidine to extremely high heat (130 degrees Fahrenheit). And Valisure included more nitrates than an average person would consume.16 The FDA said:

FDA ... developed a simulated gastric fluid (SGF) model to ... estimate the biological significance of in vitro findings. The SGF and simulated intestinal fluid (SIF) models are intended to detect the formation of NDMA in systems that approximate the stomach and intestinal fluids, respectively. The results of these tests showed no additional NDMA generated in the stomach.17

In response, Valisure claims ranitidine also created NDMA in only 37 degrees heat and with a normal quantity of nitrates (the same amount in process meats). The FDA has not yet disclosed how much NDMA it detected while it replicated Valisure's methods.18

However, the FDA's recent request that all ranitidine be withdrawn from the market lends credence to Valisure's findings. That NDMA is not merely an impurity in some Zantac lots. Instead, NMDA is created by the body from all Zantac lots.

3.2. What cancers does Zantac cause?

The science is still developing. But there appear to be links between NDMA consumption and:

  • Colorectal cancer,
  • Gastric (stomach and intestinal) cancer,
  • Liver cancer,
  • Bladder cancer,
  • Esophageal cancer,
  • Pancreatic cancer,
  • Leukemia,
  • Prostate cancer,
  • Non-Hodgkins lymphoma, or
  • Multiple myeloma

A 2018 study of the high-blood pressure medicine Valsartan (that also contains NDMA) demonstrated that, "increases in risk were observed for colorectal cancer ... and for uterine cancer."19

Learn about other Zantac side effects

4. Has Zantac been recalled?

Yes, for all intents and purposes. On April 1, 2020, the FDA requested that all drug makers withdraw their Zantac and ranitidine products.20 Before then, the following products had been voluntarily recalled:

Recall Date

Brand Name

Recalled Product

Company

02/27/2020

American Health Packaging

Ranitidine Tablets, USP 150mg

American Health Packaging

01/08/2020

Mylan Pharmaceuticals Inc.

Nizatidine Capsules 150mg and 300mg (similar to Ranitidine)

Mylan N.V.

01/08/2020

Northwind

Ranitidine Tablets 150mg and 300mg

Denton Pharma, Inc. dba Northwind Pharmaceuticals

01/07/2020

ani

Ranitidine Tablets 150mg and 300mg

Appco Pharma LLC

12/17/2019

Glenmark

Ranitidine Tablets 150mg and 300mg

Glenmark Pharmaceuticals, Inc.

11/22/2019

Amneal

Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL

Amneal Pharmaceuticals, LLC

11/19/2019

PrecisionDose

Ranitidine Oral Solution, USP 150 mg/10 mL

Precision Dose Inc.

11/15/2019

GSMS Incorporated

Ranitidine HCl 150mg and 300mg Capsules

GSMS, Inc.

11/08/2019

AHP

Ranitidine Liquid Unit Dose Cups

American Health Packaging

11/06/2019

Aurobindo & DG Health

Ranitidine

Aurobindo Pharma USA, Inc.

10/25/2019

Novitium Pharma

Ranitidine Hydrochloride Capsules 150 mg and 300 mg

Novitium Pharma

10/25/2019

Lannett Company, Inc.

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL

Lannett Company, Inc.

10/23/2019

Dr. Reddy's, Kroger, Walgreens, and others

Ranitidine Tablets & Capsules

Dr. Reddy's Laboratories Ltd.

10/23/2019

Sanofi

Zantac 150, Zantac 150 Cool Mint, Zantac 75 (OTC Products)

Sanofi

10/23/2019

Perrigo Company plc

Ranitidine (all pack sizes)

Perrigo Company plc

09/25/2019

Apotex Corp.

Ranitidine Tablets 75mg and 150mg

Apotex Corp.

09/23/2019

Sandoz Inc.

Ranitidine Hydrochloride Capsules

Sandoz Inc.

5. Can Zantac victims sue?

Yes. People who developed cancer after taking ranitidine can sue the drug manufacturers for:

  1. Defective design, and
  2. Failure to warn

5.1 Defective design

Drug manufacturers are strictly liable for the safety of their products. So they bear responsibility if both:

  1. The risk from the drug's problematic design was foreseeable, and
  2. The drug was made and used like it was intended to be21

If Valisure is correct, ranitidine molecules are naturally unstable. The ranitidine ingredient converts to NDMA in the stomach.22

Consequently, it does not matter which lot a particular Zantac dose came from. All of them are hazardous. By design, Zantac had a dangerous reaction with the body's chemistry. And people who take Zantac as instructed risk getting cancer from this dangerous reaction.

In court, attorneys will rely on various evidence to prove defective design. This will include expert witnesses in the fields of chemistry and pharmacology.

5.2 Failure to warn

As required by the FDA, Zantac has a warning label. But of all the risks it lists, it omits cancer.

Had doctors known that ranitidine could cause cancer, they probably would not have prescribed it to their patients. And had patients known it could cause cancer, they probably would not have bought it.

The most damning evidence to prove failure to warn is the Zantac labeling and packaging. It clearly excludes the carcinogenic risks of ingesting ranitidine.

(The law for proving failure to warn varies by state. In some states, the brand name drug manufacturers have a legal duty to warn generic drug users. In other states, brand name drug manufacturers do not have this duty.)23

6. Have there been settlements yet?

No. The Zantac litigation is still in early stages. But all the lawsuits will be joining together into a multi-district litigation (MDL). It is similar to a class action but with more benefits for the plaintiffs. Each lawsuit remains separate. And if the MDL is successful, each plaintiff will get a different settlement based on his or her unique injuries.

This Zantac MDL is operating out of the Southern District of Florida (West Palm Beach). The identifying MDL number is 2924. The judge presiding over the MDL is US District Judge Robin L. Rosenberg. The drug manufacturers being sued include:

It is unlikely that any settlements will occur within the next year. The judge still needs to let a few of the cases go to trial, which will take several months. And the outcome of these bellwether trials sets the stage for settlement talks.

Note that there is a limited statute of limitations to sue. So any cancer victim who took Zantac should consult with an attorney soon.

7. How big will the settlements be?

Attorneys are foreseeing large settlements. Cancer turns lives upside down and can be fatal. Plaintiffs deserve to have the drug makers pay for all of their:

  • Medical bills (including hospital stays, co-pays, rehab, medication, at-home care),
  • Mental health counseling,
  • Lost wages from being too ill to work,
  • Loss of future earnings from being too ill to work, and
  • Pain and suffering (often the biggest expense)

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Did you develop cancer after taking Zantac? Call our ranitidine lawsuit attorneys at 877-631-3652. Our goal is to win the maximum possible settlement in your case. And we take no payment unless we win. 


Legal References

  1. See Valisure, Citizen Petition on Ranitidine (September 9, 2019).
  2. 12/4/2019: FDA Updates and Press Announcements on NDMA in Zantac (ranitidine); 4/1/20: FDA Requests Removal of All Ranitidine Products (Zantac) from the Market.
  3. Richard Peto, Richard Gray, Paul Brantom and Paul Grasso, "Effects on 4080 Rats", Cancer Research (December 1991).
  4. U.S. Public Health Service in Collaboration With U.S. Environmental Protection Agency (EPA) (December 1989).
  5. See note 3.
  6. N-Nitroso-dimethylamine (NDMA), World Health Organization (WHO).
  7. Technical Fact Sheet – N-Nitroso-dimethylamine (NDMA), EPA (January 2014).
  8. See note 4.
  9. Karsten Strey: "Die Welt der Gifte", Lehmanns, 2. Edition p. 193.
  10. Roueche, Betron, "Annals of Medicine – The Prognosis for this Patient is Horrible", The New Yorker: 57–71 (January 25, 1982).
  11. "15 days log in hospital". Archived from the original on 2014-01-09. Retrieved 2013-04-30.
  12. Laboratory Tests, ranitidine, FDA (November 1, 2019).
  13. See note 1.
  14. Teng Zeng, William A. Mitch, Oral intake, Carcinogenesis, Volume 37, Issue 6, June 2016, Pages 625–634.
  15. Statement on new testing results, including low levels of impurities in ranitidine drugs, FDA (November 1, 2019).
  16. Tanya Lewis, "What We Know about the Possible Carcinogen Found in Zantac", Scientific American (October 28, 2019).
  17. See note 15.
  18. See note 16.
  19. Anton Pottegård, Kasper Bruun Kristensen, Martin Thomsen Ernst, Nanna Borup Johansen, Pierre Quartarolo, Jesper Hallas, "Contaminated Valsartan products and risk of cancer: Danish nationwide cohort study", BMJ (September 2018).
  20. FDA Requests Removal of All Ranitidine Products (Zantac) from the Market, FDA (April 1, 2020).
  21. See, e.g., In re Testosterone Replacement Therapy Prods. Liab. Litig., 136 F. Supp. 3d 968 (N.D. Ill. 2015).
  22. See note 1.
  23. See, e.g., Mut. Pharm. Co. v. Bartlett, 570 U.S. 472, 481-483 (2013); see, e.g., TH Novartis Pharm Corp., 4 Cal 5th 145, 407 P.3d 18 (Cal. 2017); Katie Thomas, "In 5-4 Ruling, Justices Say Generic Makers Are Not Liable for Design of Drugs", New York Times (June 24, 2013). 

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