Zantac Lawsuit

Leads for Attorneys

The FDA announced on September 13, 2019, that low levels of a probable human carcinogen called N-nitrosodimethlylamine (NDMA), were found in Zantac (ranitidine). As a result, major drugstores such as Walgreens and CVS have taken all generic versions of ranitidine and Zantac off their shelves until further notice from the FDA. Drug manufacturers, Sandoz (a division of Novartis) and Apotex have also decided to take action and are recalling all of their generic ranitidine drugs that are sold in the United States. Just months later, the FDA officially announced on April 1, 2020 that all ranitidine products, including Zantac, were to be taken off the market. This removal was determined appropriate after new laboratory tests on various storage scenarios for ranitidine products found dangerous NDMA-related results.

The potentially cancer-causing impurity NDMA has also been found in widely used blood pressure medications such as Valsartan. This led to multiple recalls of the drugs as well as hundreds of drug injury lawsuits. Now that the FDA is finding similar evidence of the same impurities in ranitidine drugs, ranitidine product recalls and injury lawsuits have followed. The FDA is working with multiple international agencies to review the medications and to determine if the impurities pose a health risk to users. The agency is also asking ranitidine manufacturers to perform tests on their individual products and to send samples to the FDA for additional examinations. The most recent data from the FDA and 3rd party labs have brought to attention the effect of time and storage on the levels of NDMA in ranitidine medications. It was found that NDMA levels will increase in these drugs over time, at regular temperatures, and at high temperatures.

What is Ranitidine Zantac?

The brand name for ranitidine is Zantac and it is available by prescription and over the counter (OTC). The drug is classified as a histamine H2-receptor antagonist, also known as an H2 blocker. Over the counter ranitidine is most commonly used by patients for heartburn relief that is associated with acid ingestion and sour stomach. Prescription-strength ranitidine is used to treat and prevent ulcers in the stomach and intestines, as well as to treat gastroesophageal reflux disease. The drug works by decreasing the amount of acid the stomach creates

There are various drug companies that sell generic versions of the prescription and OTC drugs. Zantac is manufactured and sold by Sanofi, a drugmaker that is all too familiar with dangerous drug lawsuits.

What is NDMA?

N-Nitrosodimethylamine, or NDMA,  is an environmental contaminant that can be found in water and food. It is considered by the Environmental Protection Agency to be a potential carcinogen (substance suspected to cause cancer) based on studies in animals. Not only is NDMA associated with causing cancer, but it can also be extremely harmful to the liver of animals and humans. According to James Brian Byrd, an assistant professor of internal medicine at the University of Michigan Medical School, ingesting NDMA could put patients at risk for disease.

New studies have also found that the level NDMA found in ranitidine medications can potentially increase as time progresses as well as with increased temperatures.

NDMA was originally used to produce rocket fuel. After unusually high amounts of this substance was found to be contaminating the water, air, and soil near the rocket fuel manufacturing plant, the use of NDMA was stopped. Unfortunately, NDMA is unintentionally created during different manufacturing processes.

Here is research that shows the link between NDMA and ranitidine:

  • A study, where 5 female and 5 male participants ingested ranitidine, found that urinary excretion of NDMA increases after oral intake of ranitidine.
  • Valisure, a pharmaceutical company, batch tested Zantac and found that one tablet has an excess of 3,000,000 ng per tablet which is significantly over the 96 ng levels of NDMA that the FDA stated as permissible.

Zantac Linked to Cancer

Zantac is a popular OTC medication that has been used by countless people throughout the nation, but now Zantac users are at risk of dangerous side effects and carcinogen exposure.

Zantac Health Issues

Serious Side Effects

  • NDMA exposure
  • Coughing up green or yellow mucus
  • Easy bruising or bleeding
  • Fast or slow heartbeat
  • Vision problems
  • Yellowing of the eyes or skin
  • Dark urine
  • Clay-colored stools

Zantac Linked to These Cancers

  • Bladder Cancer
  • Pancreatic Cancer
  • Stomach or Gastric Cancer
  • Colon or Intestinal Cancer
  • Kidney Cancer

Who is at Risk

Patients who regularly use ranitidine medications to prevent and treat heartburn, ulcers, and gastroesophageal reflux disease (GERD) are at risk of carcinogen exposure. Ranitidine is recommended for short-term use, so patients who have taken the drug for a long period of time should speak with their health care provider. More details will become available as the FDA and other regulatory agencies continue their research and examinations of ranitidine.

What Patients Should Know

  • All ranitidine medications are being removed from the market.
  • Consumers should stop taking any type of ranitidine medication and should not buy any of these medications
  • Consumers who need heartburn medications should look into alternative OTC drugs approved to treat their condition.
  • Patients who need prescription ranitidine medication should consult with their doctor to determine the best course of action before stopping ranitidine usage.

Zantac Lawsuit

Class action lawsuits have been filed against drug manufacturers Sanofi-Aventis and Boehringer Ingelheim Pharmaceuticals. The lawsuits claim the companies knew or had reason to know that Zantac exposes users to harmful quantities of NDMA when ingested. Patients who have taken Zantac will be filing more lawsuits against the manufacturers. Those who may be eligible to file a Zantac lawsuit include people who regularly took Zantac OTC or prescription for at least 60 days and were diagnosed with a form of cancer.

The removal of Zantac and other ranitidine products from the market will encourage more patients and consumers to take legal action against ranitidine drug manufacturers.

September 13, 2019

The FDA found traces of a potential carcinogen (NDMA) in the popular heartburn medication, Zantac, and other ranitidine drugs.

September 24, 2019

The FDA informed doctors and patients about a voluntary recall of 14 lots of prescription ranitidine capsules manufactured by Sandoz Inc.

September 26, 2019

The FDA informed doctors and patients about a voluntary recall of OTC ranitidine tablets manufactured by Apotex Corp. and labeled by Rite-Aid, Walmart, and Walgreens. The FDA also posted a testing method for regulators to use when examining NDMA contaminants in the drug.

October 2, 2019

The FDA announced they will be conducting tests of ranitidine medications from different manufacturers to determine the health effects on patients who have taken these drugs. Drugmakers will also conduct internal tests on their products and will be sending samples to the FDA for further research.

October 22, 2019

Sanofi announced a voluntary recall of all Zantac over-the-counter drugs in the U.S. This includes Zantac 150, Zantac 150 Cool Mint, and Zantac 75.

October 23, 2019

Dr. Reddy’s Laboratories Ltd. and its subsidiaries announced a voluntary recall for its over-the-counter and prescription ranitidine medications sold in the U.S.

November 8, 2019

Amneal Pharmaceuticals, LLC announced a voluntary recall of their Ranitidine Tablets (150 mg and 300 mg) and Ranitidine Syrup (15 mg/mL). American Health Packaging also issued a voluntary recall of eight lots of their Ranitidine Syrup (150 mg/10 mL). The recalls were announced because of potentially harmful levels of NDMA contamination.

November 21, 2019

A man from Colorado filed a Zantac lawsuit claiming that the drug caused him to develop bladder cancer in 2018. The plaintiff started using prescription Zantac in 1996 then switched to OTC Zantac, years later. He used the drug about 4 times a week through 2019.

January 2, 2020

An independent laboratory in Alameda, CA discovered that heat raises the level of NDMA in Zantac after the medication has already been packaged and is sitting on a shelf.

January 8, 2020

Mylan N.V. announced a voluntarily recall of three lots of nizatidine capsules due to detected trace amounts of NDMA in the active pharmaceutical ingredient, manufactured by Solara Active Pharma Sciences Limited.

February 6, 2020

The U.S. Judicial Panel on Multidistrict Litigation sent over 140 Zantac lawsuits to the Southern District of Florida. U.S. District Judge Robin Rosenberg will preside over the cases..

April 1, 2020

The FDA announced that it is requesting all Zantac and other prescription and over-the-counter ranitidine drugs to be removed from the market. Zantac’s withdrawal from the market was determined necessary after testing confirmed that NDMA levels increase in ranitidine while in normal storage and significantly increase under high temperatures. It was also found that the older the drug, the higher the level of NDMA.

Updates

References

Joshua Gagne. “Popular heartburn drug ranitidine recalled: What you need to know and do”, Harvard Health Blog. Accessed October 2, 2019.

FDA. “FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)”, U.S. Food and Drug Administration. Accessed October 2, 2019.

Nicole Pajer. “Here’s Why Zantac Was Pulled From Stores, And What You Should Do Now”, Huffpost. Accessed October 2, 2019.

FDA. “Sanofi Provides Update on Precautionary Voluntary Recall of Zantac OTC in U.S.“, U.S. Food & Drug Administration. Accessed October 25, 2019.

FDA. “Dr. Reddy’s Confirms its Voluntary Nationwide Recall of All Ranitidine Products in the U.S. Market“, U.S. Food & Drug Administration. Accessed October 25, 2019.

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