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.

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, more product recalls and injury lawsuits may follow. 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.

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.

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

  • Not all ranitidine medications are being recalled
  • Patients may consider alternative OTC products that are approved to help their specific conditions
  • Patients who wish to stop taking prescription ranitidine should speak with a health care professional first
  • Companies have been advised by the FDA to recall ranitidine products if NDMA levels exceed the acceptable daily intake of 96 ng

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.

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 annoucned 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.

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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