Zantac Recall Lawsuit

Zantac Linked to Bladder & Stomach Cancer

You may have heard in the news that Zantac (ranitidine) has been linked to cancer. Lawsuits against Zantac manufacturers allege the drug contains a cancer-causing chemical called N-Nitrosodimethylamine (NDMA).

The law firm of Taylor Martino is actively evaluating personal injury and wrongful death cases caused by the use of Zantac. We intend to hold the drug makers accountable for allegedly concealing the Zantac cancer link and putting profit before people.

What is Zantac?

The Facts About Zantac's FDA Recall

Zantac was first introduced to the U.S. drug market in 1983. It was already being used to treat heartburn caused by gastroesophageal reflux disease (GERD) and ulcers in over 30 countries around the globe.  By 1988, it was the world’s best-selling drug. Zantac also earned the recognition as being one of the first-ever drugs to top $1 billion in yearly sales. 

But recently, the popular drug hit a downward spiral. In late 2019, the Food and Drug Administration (FDA) found evidence of a probable human carcinogen (i.e. cancer-causing agent) in ranitidine-containing medicines, including Zantac.

While the harmful contaminant has not yet been directly linked to cancer in humans, it has been shown to cause cancer and death in animals. Some people who developed bladder and stomach cancer after taking Zantac filed lawsuits against the drug’s manufacturers. 

The Food and Drug Administration (FDA) issued a statement in September 2019, advising the public of a nitrosamine impurity called N-nitrosodimethylamine (NDMA) found in some ranitidine medicines, including Zantac.

Pharmaceutical company Valisure routinely tests all its medications. It first alerted the FDA on September 9, 2019, that it found “extremely high levels” of NDMA in ranitidine products.

This isn’t the first time that the FDA became aware of NDMA contamination in medicines containing ranitidine. The FDA began investigating NDMA in the blood pressure medication Valsartan in 2018. The drug was later recalled.

NDMA has since been found in other angiotensin II receptor blockers.

TIMELINE

Ranitidine Recalls

September 13, 2019

FDA issues its statement alerting patients and health care professionals to NDMA in some ranitidine medicines, including Zantac. FDA says investigation is ongoing. The federal agency did not ask individuals to stop taking ranitidine at thaa

September 24, 2019

FDA announces voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc. due to NDMA.

September 26, 2019

FDA alerts public to voluntary recall of over-the-counter (OTC) ranitidine tablets manufactured by Apotex Corp. and labeled by Walgreens, Walmart and Rite-Aid due to NDMA.

October 2, 2019

FDA provides update on testing of ranitidine medicines for NDMA impurities. FDA says it is assessing potential impact on patients taking ranitidine products. The federal agency also asks manufacturers of ranitidine to conduct their own testing for levels of NDMA in their medications and to send the results to FDA to be tested by its’ scientists, as well.

October 18, 2019

Zantac manufacturer Sanofi initiates a voluntary recall of all Zantac OTC medicines in the U.S. due to inconsistencies in preliminary test results of the active ingredient ranitidine in its’ products. The company says that the investigation is ongoing.

October 23, 2019

FDA releases a second method for manufacturers and regulators to test for NDMA in ranitidine products. The second method uses a “more widely available technology” than the first.

October 28, 2019

FDA alerts public to voluntary recalls of ranitidine by Perrigo Company plc, Novitium Pharma LLC and Lannett Company Inc.

November 1, 2019

FDA posts lab results that show NDMA levels in all ranitidine and nizatidine samples tested. Results also showed no additional NDMA was generated in the stomach. FDA says it will recommend recalls to manufacturers with NDMA levels above acceptable daily intake limit of 0.096 micrograms or 0.32 parts per million (PPM). Lastly, the federal agency determined that levels of ranitidine and nizatidine in samples tested were similar to levels found in common foods like grilled or smoked meats.

November 1, 2019

Director Janet Woodcock MD for the Center for Drug Evaluation and Research issues a statement the same day stating: “Although many of these levels of NDMA observed through FDA testing are much lower than the levels some third-party scientists first claimed, some levels still exceed what the FDA considers acceptable for these medicines.

November 8, 2019

FDA alerts public to voluntary recalls of ranitidine by Aurobindo Pharma USA.

November 12, 2019

FDA alerts public to voluntary recalls of ranitidine by Amneal Pharmaceuticals LLC and American Health Packaging.

November 22, 2019

FDA alerts public to voluntary recalls of ranitidine by Golden State Medical Supply and Precision Dose Inc.

December 4, 2019

FDA announces that manufacturers of ranitidine and nizatidine products have been asked to expand their testing for NDMA to include all lots of medication before they are made available to consumers. Manufacturers must inform the federal agency of all testing that shows levels of NDMA above the acceptable daily intake limit. Investigations are ongoing to determine the reasons for NDMA in these drugs, including ways in which they behave in the human body. The FDA says there is some evidence of a link between the presence of nitrates (found in processed meats) and the formation of NDMA in the body if these drugs are also present.

December 18, 2019

FDA alerts public to voluntary recalls of ranitidine by Glenmark Pharmaceutical Inc.

January 8, 2020

FDA alerts public to voluntary recalls of ranitidine by Mylan.

January 8, 2020

FDA alerts public to voluntary recalls of ranitidine by Appco Pharma LLC and Northwind Pharmaceuticals.

February 27, 2020

FDA alerts public to additional voluntary recalls of ranitidine products by American Health Packaging and Amneal Pharmaceuticals LLC.

April 1, 2020

FDA announced its request that all Zantac brand heartburn drugs, prescription and over-the-counter, be immediately pulled from the market.

April 15, 2020

After the FDA issued its market withdrawal notice, the Defense Health Agency (DHA) advised military beneficiaries to talk to their doctors about a prescription Zantac alternative in a communication dated April 15, 2020. Zantac was a popular medication prescribed to military veterans through the VA, and veterans began filing lawsuits after getting a cancer diagnosis.

Do You Need a Lawyer?

How a Zantac Lawyer Can Help

Patients injured after taking Zantac, alleged they suffered economic losses as a direct result of the drug manufacturer’s purported concealment of dangers associated with NDMA exposure from the heartburn medication. An experienced attorney can help evaluate your case and assess your specific damages to get you the maximum compensation you need for your recovery and for your family.

Medical Bills

Medical bills fall under economic damages and can include past, present and estimated future medical expenses and co-pays for treatment, surgeries, therapies, necessary medical equipment or/and prescription medications.

Punitive Damages

Punitive damages are intended to punish the other party for intentional or willful wrongdoing or gross negligence. This conduct must go beyond mere negligence and it must be proven by clear and convincing evidence.

Pain & Suffering

Pain and suffering falls under non-economic or general damages and compensates patients for emotional distress resulting from their injury. Pain and suffering can also include loss of companionship and diminished quality of life.
Zantac Injures & Side Effects

Zantac Lawsuit Injuries We’re Investigating

FDA testing found evidence of NDMA in certain ranitidine medicines, including Zantac. NDMA exposure can potentially affect the bladder, brain, liver, kidneys, lungs and stomach, per a report by the World Health Organization (WHO).  WHO also classifies NDMA as a B2 carcinogen or “probable human carcinogen,” and the U.S. National Toxicology Program lists the known environmental contaminant as a compound that is “reasonably anticipated to be a human carcinogen.”

The acceptable daily intake of NDMA is 96 mg or 0.32 parts per million for ranitidine. Exceeding that amount can expose patients to serious health risks. WHO reported that exposure to high levels of NDMA is believed to cause stomach and colorectal cancers. It is also toxic to the liver, even in small amounts.  Zantac lawsuits show that ranitidine can break down within the body to form NDMA at levels well in excess of the permissible daily intake. Plaintiffs allege they developed cancer as a result of exposure to the high levels of NDMA formed by Zantac.

Reported Zantac Injuries & Side Effects:

  • Irregular heartbeat
  • Vision problems
  • Constipation and/or Diarrhea
  • Severe headache and/or Fever
  • Jaundice (yellowing of the eyes or skin)
  • Clay-colored stools
  • Loss of Appetite, Nausea & Vomiting
  • Reduced function of liver, kidneys and lungs
  • Muscle pain, Fatigue, and Difficulty Sleeping
  • Skin rashes (severe blistering, peeling or redness)
  • Mental confusion, depression, agitation or hallucinations
  • Blood disorders (i.e. anemia, leukemia)
  • Cancer, including stomach, small intestine, colorectal, liver, bladder, esophageal, pancreatic

If you have taken Zantac in the past and you have experienced one or more of these effects, you should speak with your doctor right away. You may also qualify to participate in a Zantac Injury Lawsuit if you have experienced any of these adverse health effects.

Zantac Injury Lawyers

The Attorneys at Taylor Martino

Have Questions?

Zantac Lawsuit FAQ's

Receiving a cancer diagnosis is troubling enough on its own. Deciding whether to file a lawsuit should not add to your stress.  Our attorneys are knowledgeable about legal claims involving drug injuries. Let us help answer your questions and get you on the road to recovery. Now is time best spent with your family.

Why Is Zantac Being Recalled?

Several manufacturers of ranitidine-containing medicines, including Zantac, are recalling their products due to the presence of a probable human carcinogen (N-nitrosodimethylamine or NDMA) in these drugs at levels higher than the acceptable daily intake.

Should I Stop Taking Zantac?

The FDA recommends patients taking Zantac or other ranitidine medicines speak with their doctor before stopping or switching drug treatments. Long-term use of Zantac can sometimes lead to withdrawal symptoms, including indigestion, if stopped suddenly. People taking OTC Zantac or other ranitidine medicines should consider alternative drug treatments. FDA testing shows no NDMA in Zantac alternatives such as Pepcid, Tagamet, Nexium, Prevacid and Prilosec.

Does NDMA Cause Cancer?

NDMA is a probable human carcinogen. It is a known environmental contaminant that is found in water and foods, including meats, dairy products and vegetables, cosmetic products like shampoo, and cigarette smoke, according to the Environmental Protection Agency (EPA) and the FDA. It was also once used in the production of rocket fuel, lubricants and other industrial products. NDMA has been shown to cause cancer in animals. But its link to cancer in humans is still relatively weak. However, in very high levels, especially over extended periods of time, NDMA exposure can lead to toxicity and other harmful effects to the liver, bladder and stomach.

Do I Qualify for a Zantac Lawsuit?

If you were injured or diagnosed with certain cancers—especially bladder or stomach cancers—after taking Zantac, you might qualify for a Zantac lawsuit. You will need to show that you developed cancer as a direct result of taking Zantac. An experienced attorney can review your case and help establish your claim.

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