Ranitidine (Zantac) Lawsuits

Ranitidine (Zantac) Lawsuits

Ranitidine (brand name: Zantac) is a common medication used to treat stomach acid, acid reflux, ulcer disease, Zollinger-Ellison Syndrome (tumors that cause the stomach to produce too much acid, which results in ulcers), heartburn, and gastroesophageal disease (GERD). Available by prescription (for more serious conditions such as ulcers) and over-the-counter (OTC), ranitidine is considered one of the safest and most effective medications in our health care system since it entered the market in 1981. However, as of September 2019, ranitidine (Zantac) has been recalled and pulled from many drugstore chains (CVS, Rite-Aid, Walgreens, etc.) after the Food and Drug Administration (FDA) found a chemical in the medication that is a possible human carcinogen.

 

N-nitrosodimethylamine (NDMA) 
The September 13, 2019 press release from the FDA announced that low levels of N-nitrosodimethylamine (NDMA) were found in some ranitidine medications such as Zantac.  NDMA is a B2-carcinogen (a possible carcinogen in humans, but a known carcinogen in animals). A liquid that is yellow in color with no distinct odor, NDMA can be produced both naturally and industrially. As an environmental contaminant, it can be found in water and food, and may form during the digestion of alkylamine-containing foods. Primary sources for human exposure include the following:

 

  • Tobacco smoke
  • Chewing tobacco
  • Cured meats
  • Beer, fish, cheese
  • Toiletry and cosmetic products
  • Detergents, other household goods

 

NDMA was also once used as a research chemical, primarily in rocket-fuel. After high levels of NDMA were found air, water, and soil around rocket manufacturing plant, production ceased. As a byproduct that is produced at industrial sites, pesticide manufacturers, and rubber/tire manufacturers NDMA can be produced and released unintentionally, especially during the chlorination of drinking water and waste water.

 

Cancer Links and Health Risks

According to the Environmental Protection Agency, prolonged exposure to NDMA shows increase in tumor development in the liver and lungs; enlarged liver, reduced function of liver, kidneys, and lung; headache, fever, nausea, vomiting, abdominal cramps, and jaundice. There is also an increased risk of bladder and some stomach cancers. Zantac has allegedly been linked to the following types of cancers:

 

  • Uterine Cancer
  • Colon Cancer
  • Intestinal Cancer
  • Pancreatic Cancer
  • Ovarian Cancer
  • Esophageal Cancer
  • Liver Cancer
  • Kidney Cancer
  • Bladder Cancer
  • Lung Cancer
  • Stomach Cancer
  • Prostate Cancer

 

With regular use of Zantac, there is an increased risk in developing pneumonia and those that have a history of kidney disease, liver disease, and porphyria are advised against using the product.

 

Product Recall

After initial testing of the final product and the active ingredient in ranitidine produced inconsistent results, pharmaceutical company Sanofi issued a voluntary recall for all Zantac (OTC) in the United States in October 2019. The recall includes the following:

  • Zantac 150 ®
  • Zantac 150 ® Cool Mint
  • Zantac 75 ®

 

As an additional precautionary measure, Sanofi issued recalls in Canada since the active ingredient is sourced from multiple suppliers. Since then, the following drug companies in the United States have recalled ranitidine that are found to have NDMA levels above the acceptable limit (96 nanograms/day):

 

  • Amneal Pharmaceuticals, LLC [ranitidine tablets, 150mg]
  • Appco Pharma LLC [prescription ranitidine hydrochloride capsules]
  • Northwind Pharmaceuticals [prescription ranitidine tablets, 150mg and 300mg]
  • Glenmark Pharmaceutical Inc [prescription ranitidine tablets, 150mg and 300mg]
  • Golden State Medical Supply [ranitidine capsules, 150mg and 300mg]
  • Precision Does Inc. [ranitidine oral solution, USP 150mg/10mL]
  • American Health Packaging [ranitidine syrup, 150mg/10mL]
  • Aurobindo Pharma USA  [OTC tablets and prescription capsules, 150mg and 300mg; ranitidine syrup 15mg/mL]
  • Perrigo Company [OTC ranitidine tablets, all pack sizes]
  • Novitium Pharma LLC [ranitidine hydrochloride capsules]
  • Lannett Company, Inc. [prescription ranitidine oral solution, USP 15mg/mL]

 

Scientific Links to Cancer

This isn’t the first time concerns about NDMA levels in medications have led to a product recall. In July 2018, blood pressure medications Valsartan, Losartan, and Irbesartan were pulled from the shelves for possible NDMA contamination after the online pharmacy company Valisure detected three million nanograms of NDMA per tablet – far exceeding the permissible FDA limit of 96 nanograms. 

When determining NDMA levels in ranitidine, scientists and researchers have exposed ranitidine to artificial conditions that would replicate the human body. This includes heating samples to 98.6 degrees Fahrenheit (the average body temperature) or adding artificial nitrates (found in processed foods such as meats) which simulate gastric fluid. The purpose of this was to determine if NDMA production is triggered with the slightest change in body temperature or food consumption while ranitidine is active in the body.

Additionally, there is concern that ranitidine can break down on its own into NDMA after a 2016 study at Stanford University revealed that subjects taking 150 milligrams of Zantac were found to have high levels of NDMA in their urine. An earlier 2004 study also revealed an increase in bladder cancer among subjects who took Zantac and Tagmet daily; data did not differentiate which subjects took which medication. If it is found ranitidine can be broken down and form NDMA on its own, then it will have to be taken off the market completely.

 

Lawsuits

While low levels of NDMA have been found in ranitidine, the FDA believes the trace amounts found are no greater than the amount one may find their the food. However, since the FDA is believed to be looking for NDMA in a lab setting rather than investigating conditions relevant to the human body, testing conditions may be inaccurate.

Additionally, 80 percent of all generic drugs are made overseas and while that keeps costs down, there is a tendency for less quality control. Drug manufacturers must specifically list all ingredients in a drug that is being developed and created. If the manufacturers want to substitute one ingredient for another, approval is needed by the FDA. However, the approval process could be lengthy resulting in the drug maker using an unapproved ingredient that is cheaper to save costs. Unknown ingredients are typically linked to contaminants.

The dangers of NDMA have been known for decades and lawsuits today allege that as far back as 1981 drug makers such as Sanofi knew about NDMA forming with Zantac but failed to warn the public and healthcare providers.  A class-action lawsuit against Sanofi and Boehringer Ingelheim involves five plaintiffs who claim that Sanofi knew Zantac could produce NDMA in the human body, and by choosing to not warn the public, state consumer-protection laws were violated.

 

Do You Qualify For a Class Action Lawsuit?

Those who have taken Zantac and received a cancer diagnosis may qualify for a lawsuit against the manufacturers responsible for not disclosing the dangers associated with Zantac and NDMA formation. Medical records that show proof of prescriptions, or store receipts and doctor’s notes will can be used to establish use of Zantac or other ranitidine products. Cancer diagnoses such as stomach, bladder, colorectal, esophageal, and liver are more commonly associated with NDMA. Those who have taken the drug regularly for long periods of time are more likely to have a cancer caused by Zantac.

GPWs personal injury attorneys are investigating cases involving ranitidine and Zantac and will hold drug makers responsible for concealing the dangers associated with taking the popular acid reducing medication. If you or a family member were diagnosed with some form of cancer and have taken Zantac or other generic forms of ranitidine, you may be entitled to compensation. Contact the attorneys at Goldberg, Persky & White, P.C. to learn more.

 

 

 

 

Sources:
Agency for Toxic Substances & Disease Registry, Toxic Substances Portal – N-nitrosodimethylamine, “Public Health Statement for N-nitrosodimethylamine,” (December 1989). [Link]
World Health Organization, “Guidelines for Drinking-Water Quality,” 3rd Edition. (2008). [Link]
United States Environmental Protection Agency, “Technical Fact Sheet o – N-Nitroso-dimethylamine (NDMA) (January 2014). [Link]
U.S. Food & Drug Administration, “Sanofi Provides Update on Precautionary Recall of Zantac OTC in the U.S. (October 23, 2019). [Link]
Tayna Lewis, “What We Know about the Possible Carcinogen Found in Zantac,” Scientific American (October 28, 2019). [Link]
Josh Gagne, PharmD, ScD, “Popular Heartburn Drug Ranitidine Recalled: What you Need to Know and Do,” Harvard Health Publishing (September 2019) [Link]

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